Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease
Purpose
This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.
Condition
- Stage III Colon Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
The patient must have an ECOG performance status of 0 or 1. Patients must have histologically/pathologically confirmed Stage IIB, IIC, or Stage III colon adenocarcinoma with R0 resection according to AJCC 8th edition criteria. No radiographic evidence of overt metastatic disease within 45 days prior to Step 1/Study entry (CT with IV contrast or MRI imaging is acceptable and must include chest, abdomen, and pelvis). The distal extent of the tumor must be greater than or equal to 12 cm from the anal verge on colonoscopy or above the peritoneal reflection as documented during surgery or on pathology specimen (i.e., excluding rectal adenocarcinomas warranting treatment with chemoradiation). The patient must have had an en bloc complete gross resection of tumor (curative resection). Patients who have had a two-stage surgical procedure, to first provide a decompressive colostomy and then in a later procedure to have the definitive surgical resection, are eligible. The resected tumor specimen and a blood specimen from patients with Stage IIB, IIC, or Stage III colon cancer must have central testing for ctDNA using the Signatera™ assay by Natera (after Step 1/Study entry and before Step2/Randomization). Patient must have sufficient tissue to meet protocol requirements. This blood specimen for the Signatera assay must be collected after surgery (and recommended at least 14 days post surgery). Tumor must be documented as microsatellite stable or have intact mismatch repair proteins through CLIA-approved laboratory testing. Patients whose tumors are MSI-H or dMMR are excluded. The treating investigator must deem the patient a candidate for all potential agents used in this trial (5FU, LV, oxaliplatin and irinotecan). The interval between surgery (post-operative Day 7) and Step 1/Study entry must be no more than 60 days. NOTE: Step 1/Study Entry may occur as early as post operative Day 7, but it cannot occur beyond 60 days from the actual date of the patient's surgery. Availability and provision of adequate surgical tumor tissue for molecular diagnostics and confirmatory profiling. Adequate hematologic function within 28 days before Step 1/Study entry defined as follows: - Absolute neutrophil count (ANC) must be greater than or equal to 1500/mm3; - Participants with benign ethnic neutropenia (BEN): ANC less than 1300 mm3 are eligible. - BEN (also known as constitutional neutropenia) is an inherited cause of mild or moderate neutropenia that is not associated with any increased risk for infections or other clinical manifestations. BEN is referred to as ethnic neutropenia because of its increased prevalence in people of African descent and other specific ethnic groups. - Platelet count must be greater than or equal to 100,000/mm3; and - Hemoglobin must be greater than or equal to 9 g/dL. Adequate hepatic function within 28 days before Step 1/Study entry defined as follows: - total bilirubin must be less than or equal to ULN (upper limit of normal) for the lab and - alkaline phosphatase must be less than 2.5 x ULN for the lab; and - AST and ALT must be less than 2.5 x ULN for the lab. Adequate renal function within 28 days before Step 1/Study entry defined as serum creatinine less than or equal to 1.5 x ULN for the lab or measured or calculated creatinine clearance greater than or equal to 50 mL/min using the Cockroft-Gault formula for patients with creatinine levels greater than 1.5 x ULN for the lab. For Women Creatinine Clearance (mL/min) = (140 - age) x weight (kg) x 0.85 72 x serum creatinine (mg/dL) For Men Creatinine Clearance (mL/min) = (140 - age) x weight (kg) 72 x serum creatinine (mg/dL) NOTE: Adjusted body weight (AdjBW) should be used for patients that have BMI greater than or equal to 28 (less than or equal to 30% above IBW). HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Pregnancy test (urine or serum according to institutional standard) done within 14 days before Step 1/Study entry must be negative (for women of childbearing potential only). Patients receiving a coumarin-derivative anticoagulant must agree to weekly monitoring of INR if they are randomized to Arm 1 or Arm 3 and receive capecitabine. Eligibility Criteria for Cohort A Arm-2 patients on Second Randomization Patient must have developed a ctDNA +ve assay during serial monitoring. Patient's willingness to be re-randomized affirmed. The patient must continue to have an ECOG performance status of 0 or 1. No radiographic evidence of overt metastatic disease. Pregnancy test (urine or serum according to institutional standard) done within 14 days before second randomization must be negative (for women of childbearing potential only). Adequate hematologic function within 28 days before second randomization defined as follows: - Absolute neutrophil count (ANC) must be greater than or equal to 1500/mm3; - Participants with benign ethnic neutropenia (BEN): ANC less than 1300 mm3 are eligible. - BEN (also known as constitutional neutropenia) is an inherited cause of mild or moderate neutropenia that is not associated with any increased risk for infections or other clinical manifestations. BEN is referred to as ethnic neutropenia because of its increased prevalence in people of African descent and other specific ethnic groups. - Platelet count must be greater than or equal to 100,000/mm3; and - Hemoglobin must be greater than or equal to 9 g/dL. Adequate hepatic function within 28 days before second randomization defined as follows: - total bilirubin must be less than or equal to ULN (upper limit of normal) for the lab and - alkaline phosphatase must be less than 2.5 x ULN for the lab; and - AST and ALT must be less than 2.5 x ULN for the lab. Adequate renal function within 28 days before second randomization defined as serum creatinine less than or equal to 1.5 x ULN for the lab or measured or calculated creatinine clearance greater than or equal to 50 mL/min using the Cockroft-Gault formula for patients with creatinine levels greater than 1.5 x ULN for the lab. For Women Creatinine Clearance (mL/min) = (140 - age) x weight (kg) x 0.85 72 x serum creatinine (mg/dL) For Men Creatinine Clearance (mL/min) = (140 - age) x weight (kg) 72 x serum creatinine (mg/dL)
Exclusion Criteria
Colon cancer histology other than adenocarcinoma (i.e., neuroendocrine carcinoma, sarcoma, lymphoma, squamous cell carcinoma, etc.). Pathologic, clinical, or radiologic overt evidence of metastatic disease. This includes isolated, distant, or non-contiguous intra-abdominal metastases, even if resected. Tumor-related bowel perforation. History of prior invasive colon malignancy, regardless of disease-free interval. History of bone marrow or solid organ transplantation (regardless of current immunosuppressive therapy needs). Bone grafts, skin grafts, corneal transplants and organ/tissue donation are not exclusionary. Any prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer (e.g., primary colon adenocarcinomas for which treatment with neoadjuvant chemotherapy and/or radiation is warranted are not permitted). EXCEPTION: one cycle of chemotherapy (regimen per treating physicians' discretion - 5-FU or capecitabine with or without oxaliplatin) is allowed but not required after consent. The optional cycle of chemotherapy should be started greater than or equal to 4 weeks from surgery and while awaiting Step 2 randomization. Other invasive malignancy within 5 years before Step 1/Study entry. Exceptions are colonic polyps, non-melanoma skin cancer or any carcinoma-in-situ. Synchronous primary rectal and/ or colon cancers. Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better. Sensory or motor neuropathy greater than or equal to grade 2, according to CTCAE v5.0. Blood transfusion within two weeks before collection of blood for central ctDNA testing. Active seizure disorder uncontrolled by medication. Active or chronic infection requiring systemic therapy. Known homozygous DPD (dihydropyrimidine dehydrogenase) deficiency. Patients known to have Gilbert's Syndrome or homozygosity for UGT1A1*28 polymorphism. Pregnancy or lactation at the time of Step 1/Study entry. Co-morbid illnesses or other concurrent disease that would make the patient inappropriate for entry into this study (i.e., unable to tolerate 6 months of combination chemotherapy or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens or prevent required follow-up). Ineligibility Criteria for Cohort A Arm-2 patients on Second Randomization Pregnancy or lactation at the time of randomization. No longer a candidate for systemic chemotherapy (FOLFOX, CAPOX, and mFOLFIRINOX) in the opinion of the treating investigator.
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Active Comparator Cohort A - Arm 1 (ctDNA-ve) |
Oxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + 5-Fluorouracil (5-FU) 400mg/m2 bolus + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 6-12 cycles OR Oxaliplatin 130 mg/m2 IV Day 1 every 3 weeks + Capecitabine 1000 mg/m2 BID by mouth days 1-14 every 3 weeks for 4 cycles |
|
Experimental Cohort A - Arm 2 (ctDNA-ve) |
Serial ctDNA monitoring no treatment |
|
Active Comparator Cohort B - Arm 3 (ctDNA+ve) |
Oxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + 5-Fluorouracil (5-FU) 400mg/m2 bolus + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 12 cycles OR Oxaliplatin 130 mg/m2 IV Day 1 every 3 weeks + Capecitabine 1000 mg/m2 BID by mouth days 1-14 every 3 weeks for 8 cycles |
|
Experimental Cohort B - Arm 4 (ctDNA+ve) |
Oxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + Irinotecan 150 mg/m2 IV continuous infusion (30-90 minutes) + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 12 cycles |
|
Recruiting Locations
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Des Moines 4853828, Iowa 4862182 50314
Des Moines 4853828, Iowa 4862182 50314
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515-241-3305
Fort Dodge 4857486, Iowa 4862182 50501
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515-956-4132
Iowa City 4862034, Iowa 4862182 52242
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800-237-1225
Jefferson 4862482, Iowa 4862182 50129
Site Public Contact
515-956-4132
Marshalltown 4866371, Iowa 4862182 50158
Site Public Contact
515-956-4132
Sioux City 4876523, Iowa 4862182 51101
Waukee 4880981, Iowa 4862182 50263
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515-241-3305
West Des Moines 4881346, Iowa 4862182 50266
Garden City 5445439, Kansas 4273857 67846
Great Bend 4272340, Kansas 4273857 67530
Overland Park 4276873, Kansas 4273857 66213
Wichita 4281730, Kansas 4273857 67208
Wichita 4281730, Kansas 4273857 67214
Bardstown 4283133, Kentucky 6254925 40004
Corbin 4288656, Kentucky 6254925 40701
Lexington 4297983, Kentucky 6254925 40503
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859-260-6425
Lexington 4297983, Kentucky 6254925 40504
Lexington 4297983, Kentucky 6254925 40509
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866-213-3025
Lexington 4297983, Kentucky 6254925 40509
London 4298960, Kentucky 6254925 40741
Louisville 4299276, Kentucky 6254925 40202
Louisville 4299276, Kentucky 6254925 40202
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502-562-3429
Louisville 4299276, Kentucky 6254925 40217
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502-629-3465
Louisville 4299276, Kentucky 6254925 40241
Louisville 4299276, Kentucky 6254925 40245
Baton Rouge 4315588, Louisiana 4331987 70805
Baton Rouge 4315588, Louisiana 4331987 70808
Baton Rouge 4315588, Louisiana 4331987 70816
Baton Rouge 4315588, Louisiana 4331987 70836
Covington 4321005, Louisiana 4331987 70433
Marrero 4332628, Louisiana 4331987 70072
New Orleans 4335045, Louisiana 4331987 70112
New Orleans 4335045, Louisiana 4331987 70112
New Orleans 4335045, Louisiana 4331987 70121
Augusta 4957003, Maine 4971068 04330
Site Public Contact
207-626-4855
Biddeford 4958141, Maine 4971068 04005
Sanford 4977762, Maine 4971068 04073
Sanford 4977762, Maine 4971068 04073
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207-459-1600
South Portland 4979244, Maine 4971068 04106
Aberdeen 4346913, Maryland 4361885 21001
Baltimore 4347778, Maryland 4361885 21204
Site Public Contact
443-849-3706
Baltimore 4347778, Maryland 4361885 21215
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410-601-9083
Baltimore 4347778, Maryland 4361885 21229
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410-368-2910
Baltimore 4347778, Maryland 4361885 21237
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443-777-7364
Baltimore 4347778, Maryland 4361885 21239
Baltimore 4347778, Maryland 4361885 21244
Bel Air 4348240, Maryland 4361885 21014
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443-643-3010
Cumberland 4352681, Maryland 4361885 21502
Site Public Contact
240-964-1400
Frederick 4355585, Maryland 4361885 21701
Frederick 4355585, Maryland 4361885 21702
Site Public Contact
301-668-7043
Gaithersburg 4355843, Maryland 4361885 20879
Glen Burnie 4356188, Maryland 4361885 21061
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410-553-8100
Largo 4360345, Maryland 4361885 20774
Lutherville 4361379, Maryland 4361885 21093
Westminster 4373238, Maryland 4361885 21157
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410-871-6400
Beverly 4930505, Massachusetts 6254926 01915
Site Public Contact
978-922-3000
Boston 4930956, Massachusetts 6254926 02111
Boston 4930956, Massachusetts 6254926 02118
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617-638-8265
Brighton 4931353, Massachusetts 6254926 02135
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617-789-2903
Burlington 4931737, Massachusetts 6254926 01805
Foxborough 4937222, Massachusetts 6254926 02035
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877-338-7425
Gloucester 4937829, Massachusetts 6254926 01930
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978-283-4000
Methuen 4943828, Massachusetts 6254926 01844
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877-338-7425
Milford 4943958, Massachusetts 6254926 01757
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877-332-4294
Peabody 4946863, Massachusetts 6254926 01960
South Weymouth 4951568, Massachusetts 6254926 02190
Site Public Contact
781-624-5000
Ann Arbor 4984247, Michigan 5001836 48106
Ann Arbor 4984247, Michigan 5001836 48109
Battle Creek 4985153, Michigan 5001836 49017
Brighton 4986994, Michigan 5001836 48114
Brighton 4986994, Michigan 5001836 48114
Canton 4987990, Michigan 5001836 48188
Canton 4987990, Michigan 5001836 48188
Chelsea 4988628, Michigan 5001836 48118
Chelsea 4988628, Michigan 5001836 48118
Clarkston 4988997, Michigan 5001836 48346
Clarkston 4988997, Michigan 5001836 48346
Dearborn 4990510, Michigan 5001836 48124
Site Public Contact
248-551-7695
Detroit 4990729, Michigan 5001836 48236
East China Township, Michigan 5001836 48054
Escanaba 4992232, Michigan 5001836 49829
Flint 4992982, Michigan 5001836 48503
Flint 4992982, Michigan 5001836 48503
Flint 4992982, Michigan 5001836 48503
Flint 4992982, Michigan 5001836 48503
Grand Rapids 4994358, Michigan 5001836 49503
Grand Rapids 4994358, Michigan 5001836 49503
Grosse Pointe Woods 4994871, Michigan 5001836 48236
Grosse Pointe Woods 4994871, Michigan 5001836 48236
Grosse Pointe Woods 4994871, Michigan 5001836 48236
Kalamazoo 4997787, Michigan 5001836 49007
Kalamazoo 4997787, Michigan 5001836 49007
Kalamazoo 4997787, Michigan 5001836 49009
Site Public Contact
574-647-7370
Lansing 4998830, Michigan 5001836 48912
Livonia 4999837, Michigan 5001836 48154
Macomb 5000473, Michigan 5001836 48044
Macomb 5000473, Michigan 5001836 48044
Muskegon 5003132, Michigan 5001836 49444
Norton Shores 5004005, Michigan 5001836 49444
Novi 5004062, Michigan 5001836 48374
Pontiac 5006166, Michigan 5001836 48341
Pontiac 5006166, Michigan 5001836 48341
Pontiac 5006166, Michigan 5001836 48341
Pontiac 5006166, Michigan 5001836 48341
Reed City 5006946, Michigan 5001836 49677
Royal Oak 5007804, Michigan 5001836 48073
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248-551-7695
Saginaw 5007989, Michigan 5001836 48601
Saint Joseph 5008327, Michigan 5001836 49085
Southfield 5010636, Michigan 5001836 48075
Tawas City 5011900, Michigan 5001836 48764
Traverse City 5012495, Michigan 5001836 49684
Troy 5012639, Michigan 5001836 48085
Site Public Contact
248-551-7695
Warren 5014051, Michigan 5001836 48093
Warren 5014051, Michigan 5001836 48093
Warren 5014051, Michigan 5001836 48093
Wyoming 5015618, Michigan 5001836 49519
Ypsilanti 5015688, Michigan 5001836 48106
Ypsilanti 5015688, Michigan 5001836 48197
Bemidji 5017822, Minnesota 5037779 56601
Brainerd 5019116, Minnesota 5037779 56401
Burnsville 5019767, Minnesota 5037779 55337
Coon Rapids 5022025, Minnesota 5037779 55433
Deer River 5024099, Minnesota 5037779 56636
Detroit Lakes 5024237, Minnesota 5037779 56501
Duluth 5024719, Minnesota 5037779 55805
Edina 5025264, Minnesota 5037779 55435
Hibbing 5030005, Minnesota 5037779 55746
Site Public Contact
218-786-3308
Maple Grove 5036493, Minnesota 5037779 55369
Maplewood 5036588, Minnesota 5037779 55109
Maplewood 5036588, Minnesota 5037779 55109
Minneapolis 5037649, Minnesota 5037779 55407
Minneapolis 5037649, Minnesota 5037779 55415
Monticello 5038045, Minnesota 5037779 55362
Moose Lake 5038132, Minnesota 5037779 55767
Site Public Contact
218-485-4481
New Ulm 5039173, Minnesota 5037779 56073
Princeton 5042360, Minnesota 5037779 55371
Robbinsdale 5043439, Minnesota 5037779 55422
Saint Cloud 5044407, Minnesota 5037779 56303
Saint Louis Park 5045021, Minnesota 5037779 55416
Saint Paul 5045360, Minnesota 5037779 55101
Saint Paul 5045360, Minnesota 5037779 55102
Sandstone 5045908, Minnesota 5037779 55072
Shakopee 5046997, Minnesota 5037779 55379
Stillwater 5048814, Minnesota 5037779 55082
Thief River Falls 5049970, Minnesota 5037779 56701
Site Public Contact
605-312-3320
Virginia 5051468, Minnesota 5037779 55792
Waconia 5051640, Minnesota 5037779 55387
Willmar 5052916, Minnesota 5037779 56201
Woodbury 5053358, Minnesota 5037779 55125
Worthington 5053460, Minnesota 5037779 56187
Site Public Contact
605-312-3320
Wyoming 5053526, Minnesota 5037779 55092
Columbus 4422442, Mississippi 4436296 39705
Grenada 4428539, Mississippi 4436296 38901
Jackson 4431410, Mississippi 4436296 39216
Site Public Contact
601-815-6700
New Albany 4438121, Mississippi 4436296 38652
Oxford 4440076, Mississippi 4436296 38655
Southhaven 4446702, Mississippi 4436296 38671
Ballwin 4375663, Missouri 4398678 63011
Site Public Contact
888-446-3729
Bolivar 4377835, Missouri 4398678 65613
Branson 4378219, Missouri 4398678 65616
Site Public Contact
417-269-4520
Cape Girardeau 4379966, Missouri 4398678 63703
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888-446-3729
Cape Girardeau 4379966, Missouri 4398678 63703
City of Saint Peters 4407237, Missouri 4398678 63376
Columbia 4381982, Missouri 4398678 65212
Site Public Contact
573-882-7440
Creve Coeur 4382837, Missouri 4398678 63141
Farmington 4386289, Missouri 4398678 63640
Site Public Contact
314-996-5569
Joplin 4392768, Missouri 4398678 64804
Joplin 4392768, Missouri 4398678 64804
Kansas City 4393217, Missouri 4398678 64111
Lee's Summit 4394870, Missouri 4398678 64086
Rolla 4406282, Missouri 4398678 65401
Site Public Contact
573-458-6379
Rolla 4406282, Missouri 4398678 65401
Saint Joseph 4407010, Missouri 4398678 64506
Sainte Genevieve 4407294, Missouri 4398678 63670
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314-996-5569
Springfield 4409896, Missouri 4398678 65804
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417-269-4520
Springfield 4409896, Missouri 4398678 65807
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417-269-4520
St Louis 4407066, Missouri 4398678 63109
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888-446-3729
St Louis 4407066, Missouri 4398678 63110
St Louis 4407066, Missouri 4398678 63128
St Louis 4407066, Missouri 4398678 63129
St Louis 4407066, Missouri 4398678 63131
Site Public Contact
314-996-5569
St Louis 4407066, Missouri 4398678 63136
St Louis 4407066, Missouri 4398678 63141
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314-251-7066
Sullivan 4410669, Missouri 4398678 63080
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314-996-5569
Sunset Hills 4410836, Missouri 4398678 63127
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314-996-5569
Washington 4413621, Missouri 4398678 63090
Site Public Contact
636-390-1600
Anaconda 5637146, Montana 5667009 59711
Billings 5640350, Montana 5667009 59101
Billings 5640350, Montana 5667009 59102
Site Public Contact
800-648-6274
Bozeman 5641727, Montana 5667009 59715
Great Falls 5655240, Montana 5667009 59405
Great Falls 5655240, Montana 5667009 59405
Kalispell 5660340, Montana 5667009 59901
Missoula 5666639, Montana 5667009 59804
Kearney 5071348, Nebraska 5073708 68847
Lincoln 5072006, Nebraska 5073708 68516
Omaha 5074472, Nebraska 5073708 68122
Omaha 5074472, Nebraska 5073708 68124
Omaha 5074472, Nebraska 5073708 68130
Omaha 5074472, Nebraska 5073708 68131
Carson City 5501344, Nevada 5509151 89703
Henderson 5505411, Nevada 5509151 89052
Henderson 5505411, Nevada 5509151 89052
Las Vegas 5506956, Nevada 5509151 89102
Las Vegas 5506956, Nevada 5509151 89148
Las Vegas 5506956, Nevada 5509151 89148
Las Vegas 5506956, Nevada 5509151 89169
Reno 5511077, Nevada 5509151 89502
Reno 5511077, Nevada 5509151 89503
Concord 5084868, New Hampshire 5090174 03301
Site Public Contact
603-224-2556
Exeter 5085966, New Hampshire 5090174 03833
Site Public Contact
800-439-3837
Lebanon 5088597, New Hampshire 5090174 03756
Londonderry 5088905, New Hampshire 5090174 03053
Manchester 5089178, New Hampshire 5090174 03103
Site Public Contact
800-339-6484
Berkeley Heights 5095617, New Jersey 5101760 07922
Cape May Court House 4501057, New Jersey 5101760 08210
Site Public Contact
609-677-7735
Cherry Hill 4501198, New Jersey 5101760 08002
Egg Harbor 8766331, New Jersey 5101760 08234
Site Public Contact
609-748-7200
Elizabeth 5097598, New Jersey 5101760 07207
Site Public Contact
908-994-8000
Florham Park 5098095, New Jersey 5101760 07932
Hamilton 5098765, New Jersey 5101760 08690
Site Public Contact
609-631-6946
Jersey City 5099836, New Jersey 5101760 07302
Lakewood 5100280, New Jersey 5101760 08701
Livingston 5100572, New Jersey 5101760 07039
Long Branch 5100619, New Jersey 5101760 07740
Morristown 5101427, New Jersey 5101760 07960
Site Public Contact
973-971-5900
New Brunswick 5101717, New Jersey 5101760 08903
Site Public Contact
732-235-7356
Newark 5101798, New Jersey 5101760 07101
Site Public Contact
732-235-7356
Newark 5101798, New Jersey 5101760 07112
Sewell 4504048, New Jersey 5101760 08080
Somerville 5104774, New Jersey 5101760 08876
Summit 5105127, New Jersey 5101760 07902
Site Public Contact
908-522-2043
Toms River 4504476, New Jersey 5101760 08755
Albuquerque 5454711, New Mexico 5481136 87106
Albuquerque 5454711, New Mexico 5481136 87110
Las Cruces 5475352, New Mexico 5481136 88011
Rio Rancho 5487811, New Mexico 5481136 87124
Brooklyn 5110302, New York 5128638 11215
Flushing 5117472, New York 5128638 11355
Glens Falls 5118693, New York 5128638 12801
Site Public Contact
518-926-6700
Greenlawn 5119377, New York 5128638 11740
Site Public Contact
516-734-8896
Lake Success 5123853, New York 5128638 11042
Site Public Contact
516-734-8896
Middletown 5126842, New York 5128638 10940
Mount Kisco 5127744, New York 5128638 10549
New York 5128581, New York 5128638 10019
New York 5128581, New York 5128638 10029
New York 5128581, New York 5128638 10065
Site Public Contact
212-434-4460
New York 5128581, New York 5128638 10065
Site Public Contact
212-746-1848
New York 5128581, New York 5128638 10075
Site Public Contact
516-734-8896
Rego Park 5133640, New York 5128638 11374
Site Public Contact
718-312-3446
Rochester 5134086, New York 5128638 14621
Rochester 5134086, New York 5128638 14626
Rochester 5134086, New York 5128638 14642
Site Public Contact
585-275-5830
Sleepy Hollow 5138371, New York 5128638 10591
Site Public Contact
914-366-1600
Staten Island 5139568, New York 5128638 10305
Site Public Contact
718-226-8888
Stony Brook 5139865, New York 5128638 11794
Site Public Contact
800-862-2215
The Bronx 5110266, New York 5128638 10461
Webster 5143495, New York 5128638 14580
Cary 4459467, North Carolina 4482348 27518
Cary 4459467, North Carolina 4482348 27518
Chapel Hill 4460162, North Carolina 4482348 27599
Charlotte 4460243, North Carolina 4482348 28203
Site Public Contact
800-804-9376
Charlotte 4460243, North Carolina 4482348 28210
Site Public Contact
980-442-2000
Charlotte 4460243, North Carolina 4482348 28211
Site Public Contact
980-442-2000
Charlotte 4460243, North Carolina 4482348 28262
Site Public Contact
800-804-9376
Charlotte 4460243, North Carolina 4482348 28277
Site Public Contact
800-804-9376
Clinton 4461101, North Carolina 4482348 28328
Concord 4461574, North Carolina 4482348 28025
Site Public Contact
800-804-9376
Durham 4464368, North Carolina 4482348 27710
Site Public Contact
888-275-3853
Garner 4467657, North Carolina 4482348 27529
Gastonia 4467732, North Carolina 4482348 28054
Goldsboro 4468261, North Carolina 4482348 27534
Greenville 4469160, North Carolina 4482348 27834
Hendersonville 4470592, North Carolina 4482348 28791
Jacksonville 4473083, North Carolina 4482348 28546
Monroe 4479946, North Carolina 4482348 28112
Site Public Contact
980-442-2000
Pinehurst 4485272, North Carolina 4482348 28374
Raleigh 4487042, North Carolina 4482348 27607
Raleigh 4487042, North Carolina 4482348 27609
Raleigh 4487042, North Carolina 4482348 27614
Winston-Salem 4499612, North Carolina 4482348 27157
Site Public Contact
336-713-6771
Bismarck 5688025, North Dakota 5690763 58501
Fargo 5059163, North Dakota 5690763 58103
Fargo 5059163, North Dakota 5690763 58122
Fargo 5059163, North Dakota 5690763 58122
Grand Forks 5059429, North Dakota 5690763 58201
Site Public Contact
701-780-6520
Akron 5145476, Ohio 5165418 44304
Akron 5145476, Ohio 5165418 44307
Alliance 5145607, Ohio 5165418 44601
Site Public Contact
330-363-1250
Barberton 5146491, Ohio 5165418 44203
Beavercreek 4506008, Ohio 5165418 45431
Belpre 4506187, Ohio 5165418 45714
Boardman 5147784, Ohio 5165418 44512
Canton 5149222, Ohio 5165418 44708
Site Public Contact
888-293-4673
Canton 5149222, Ohio 5165418 44710
Centerville 4508204, Ohio 5165418 45459
Centerville 4508204, Ohio 5165418 45459
Chillicothe 4828890, Ohio 5165418 45601
Cincinnati 4508722, Ohio 5165418 45219
Cincinnati 4508722, Ohio 5165418 45220
Cincinnati 4508722, Ohio 5165418 45236
Cincinnati 4508722, Ohio 5165418 45242
Cincinnati 4508722, Ohio 5165418 45247
Cincinnati 4508722, Ohio 5165418 45255
Cleveland 5150529, Ohio 5165418 44109
Cleveland 5150529, Ohio 5165418 44111
Cleveland 5150529, Ohio 5165418 44195
Columbus 4509177, Ohio 5165418 43210
Columbus 4509177, Ohio 5165418 43213
Columbus 4509177, Ohio 5165418 43219
Columbus 4509177, Ohio 5165418 43222
Dayton 4509884, Ohio 5165418 45409
Dayton 4509884, Ohio 5165418 45409
Site Public Contact
937-276-8320
Dayton 4509884, Ohio 5165418 45415
Dayton 4509884, Ohio 5165418 45415
Findlay 5153924, Ohio 5165418 45840
Findlay 5153924, Ohio 5165418 45840
Findlay 5153924, Ohio 5165418 45840
Franklin 4512203, Ohio 5165418 45005-1066
Franklin 4512203, Ohio 5165418 45005
Gahanna 5155393, Ohio 5165418 43230
Greenville 5156493, Ohio 5165418 45331
Greenville 5156493, Ohio 5165418 45331
Site Public Contact
937-569-7515
Greenville 5156493, Ohio 5165418 45331
Grove City 4513409, Ohio 5165418 43123
Independence 5158404, Ohio 5165418 44131
Kettering 4515843, Ohio 5165418 45409
Kettering 4515843, Ohio 5165418 45429
Lancaster 4516233, Ohio 5165418 43130
Lima 5160783, Ohio 5165418 45801
Mansfield 5161723, Ohio 5165418 44906
Marietta 4517586, Ohio 5165418 45750
Mayfield Heights 5162188, Ohio 5165418 44124
Medina 5162512, Ohio 5165418 44256
Mount Vernon 5163799, Ohio 5165418 43050
New Albany 5164202, Ohio 5165418 43054
Newark 5164466, Ohio 5165418 43055
Newark 5164466, Ohio 5165418 43055
Perrysburg 5166516, Ohio 5165418 43551
Portsmouth 4521816, Ohio 5165418 45662
Sandusky 5170691, Ohio 5165418 44870
Springfield 4525353, Ohio 5165418 45504
Springfield 4525353, Ohio 5165418 45504
Steubenville 5173048, Ohio 5165418 43952
Site Public Contact
888-874-7000
Strongsville 5173237, Ohio 5165418 44136
Sylvania 5173572, Ohio 5165418 43560
Toledo 5174035, Ohio 5165418 43606
Toledo 5174035, Ohio 5165418 43608
Toledo 5174035, Ohio 5165418 43623
Toledo 5174035, Ohio 5165418 43623
Troy 5174358, Ohio 5165418 45373
Troy 5174358, Ohio 5165418 45373
Warren 5175865, Ohio 5165418 44484
Warrensville Heights 5175726, Ohio 5165418 44122
West Chester 4520522, Ohio 5165418 45069
Westerville 5176472, Ohio 5165418 43081
Wooster 5177358, Ohio 5165418 44691
Youngstown 5177568, Ohio 5165418 44501
Zanesville 4528923, Ohio 5165418 43701
Lawton 4540737, Oklahoma 4544379 73505
Site Public Contact
877-231-4440
Oklahoma City 4544349, Oklahoma 4544379 73104
Oklahoma City 4544349, Oklahoma 4544379 73109
Oklahoma City 4544349, Oklahoma 4544379 73120
Site Public Contact
405-752-3402
Oklahoma City 4544349, Oklahoma 4544379 73142
Site Public Contact
405-773-6613
Tulsa 4553433, Oklahoma 4544379 74146
Site Public Contact
918-505-3200
Clackamas 5719308, Oregon 5744337 97015
Newberg 5742726, Oregon 5744337 97132
Ontario 5744166, Oregon 5744337 97914
Oregon City 5744253, Oregon 5744337 97045
Portland 5746545, Oregon 5744337 97213
Portland 5746545, Oregon 5744337 97225
Portland 5746545, Oregon 5744337 97227
Allentown 5178127, Pennsylvania 6254927 18103
Altoona 5178195, Pennsylvania 6254927 16601
Beaver 5179446, Pennsylvania 6254927 15009
Bethlehem 5180225, Pennsylvania 6254927 18017
Butler 5182534, Pennsylvania 6254927 16001
Carlisle 5183234, Pennsylvania 6254927 17015
Chambersburg 4557109, Pennsylvania 6254927 17201
Site Public Contact
717-217-6020
Cranberry Township 8643098, Pennsylvania 6254927 16066
Danville 5186327, Pennsylvania 6254927 17822
East Stroudsburg 5188075, Pennsylvania 6254927 18301
Ephrata 5188815, Pennsylvania 6254927 17522
Site Public Contact
717-721-4840
Erie 5188843, Pennsylvania 6254927 16505
Erie 5188843, Pennsylvania 6254927 16544
Site Public Contact
814-452-5000
Farrell 5189377, Pennsylvania 6254927 16121
Gettysburg 4558183, Pennsylvania 6254927 17325
Site Public Contact
877-441-7957
Greensburg 5192029, Pennsylvania 6254927 15601
Site Public Contact
724-838-1900
Harrisburg 5192726, Pennsylvania 6254927 17109
Hazleton 5193011, Pennsylvania 6254927 18201
Hazleton 5193011, Pennsylvania 6254927 18201
Hershey 5193342, Pennsylvania 6254927 17033-0850
Indiana 5194868, Pennsylvania 6254927 15701
Jefferson Hills 5195297, Pennsylvania 6254927 15025
Johnstown 5195561, Pennsylvania 6254927 15901
Site Public Contact
814-534-4724
Lebanon 5197517, Pennsylvania 6254927 17042
Lewisburg 5197842, Pennsylvania 6254927 17837
McKeesport 5200499, Pennsylvania 6254927 15132
Site Public Contact
412-647-8073
Mechanicsburg 5200657, Pennsylvania 6254927 17050
Monroeville 5201734, Pennsylvania 6254927 15146
Site Public Contact
412-858-7746
Monroeville 5201734, Pennsylvania 6254927 15146
Moon Township 5201821, Pennsylvania 6254927 15108
N. Huntingdon, Pennsylvania 6254927 15642
Natrona Heights 5202903, Pennsylvania 6254927 15065
Natrona Heights 5202903, Pennsylvania 6254927 15065
Site Public Contact
724-230-3030
New Castle 5203127, Pennsylvania 6254927 16105
Philadelphia 4560349, Pennsylvania 6254927 19104
Philadelphia 4560349, Pennsylvania 6254927 19107
Philadelphia 4560349, Pennsylvania 6254927 19107
Philadelphia 4560349, Pennsylvania 6254927 19114
Phoenixville 5205849, Pennsylvania 6254927 19460
Site Public Contact
610-983-1800
Pittsburgh 5206379, Pennsylvania 6254927 15212
Site Public Contact
877-284-2000
Pittsburgh 5206379, Pennsylvania 6254927 15213
Site Public Contact
412-647-2811
Pittsburgh 5206379, Pennsylvania 6254927 15215
Site Public Contact
412-784-4900
Pittsburgh 5206379, Pennsylvania 6254927 15219
Site Public Contact
800-533-8762
Pittsburgh 5206379, Pennsylvania 6254927 15224
Site Public Contact
412-578-5000
Pittsburgh 5206379, Pennsylvania 6254927 15232
Site Public Contact
412-647-8073
Pittsburgh 5206379, Pennsylvania 6254927 15232
Site Public Contact
412-621-2334
Pittsburgh 5206379, Pennsylvania 6254927 15237
Site Public Contact
412-367-6454
Pittsburgh 5206379, Pennsylvania 6254927 15243
Site Public Contact
412-502-3920
Scranton 5211303, Pennsylvania 6254927 18510
Seneca 5211432, Pennsylvania 6254927 16346
Site Public Contact
814-676-7900
Uniontown 4561859, Pennsylvania 6254927 15401
Washington 5218069, Pennsylvania 6254927 15301
West Chester 4562144, Pennsylvania 6254927 19380
West Reading 5218867, Pennsylvania 6254927 19611
Site Public Contact
610-988-9323
Wexford 5219062, Pennsylvania 6254927 15090
Wilkes-Barre 5219488, Pennsylvania 6254927 18711
Williamsport 5219585, Pennsylvania 6254927 17754
Willow Grove 5219619, Pennsylvania 6254927 19090
York 4562407, Pennsylvania 6254927 17403
Site Public Contact
717-741-9229
York 4562407, Pennsylvania 6254927 17403
Site Public Contact
877-441-7957
York 4562407, Pennsylvania 6254927 17403
Site Public Contact
877-441-7957
York 4562407, Pennsylvania 6254927 17408
Site Public Contact
717-724-6760
Providence 5224151, Rhode Island 5224323 02908
Westerly 5225631, Rhode Island 5224323 02891
Boiling Springs 4571805, South Carolina 4597040 29316
Charleston 4574324, South Carolina 4597040 29425
Easley 4577263, South Carolina 4597040 29640
Greenville 4580543, South Carolina 4597040 29605
Greenville 4580543, South Carolina 4597040 29605
Greenville 4580543, South Carolina 4597040 29615
Greer 4580599, South Carolina 4597040 29650
Greer 4580599, South Carolina 4597040 29651
Seneca 4595346, South Carolina 4597040 29672
Spartanburg 4597200, South Carolina 4597040 29303
Union 4599214, South Carolina 4597040 29379
Aberdeen 5225857, South Dakota 5769223 57401
Mitchell 5229794, South Dakota 5769223 57301
Pierre 5767918, South Dakota 5769223 57501
Rapid City 5768233, South Dakota 5769223 57701
Sioux Falls 5231851, South Dakota 5769223 57104
Sioux Falls 5231851, South Dakota 5769223 57105
Sioux Falls 5231851, South Dakota 5769223 57117-5134
Yankton 5233053, South Dakota 5769223 57078
Collierville 4614748, Tennessee 4662168 38017
Germantown 4624601, Tennessee 4662168 38138
Memphis 4641239, Tennessee 4662168 38120
Nashville 4644585, Tennessee 4662168 37232
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Amarillo 5516233, Texas 4736286 79106
Austin 4671654, Texas 4736286 78701
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512-324-7991
Austin 4671654, Texas 4736286 78712
Conroe 4682991, Texas 4736286 77384
Dallas 4684888, Texas 4736286 75235
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Dallas 4684888, Texas 4736286 75390
Edinburg 4688275, Texas 4736286 78539
Fort Worth 4691930, Texas 4736286 76104
Galveston 4692883, Texas 4736286 77555-0565
Houston 4699066, Texas 4736286 77026-1967
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Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
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Houston 4699066, Texas 4736286 77030
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League City 4705692, Texas 4736286 77573
Richardson 4722625, Texas 4736286 75080
Sugar Land 4734825, Texas 4736286 77478
Temple 4735966, Texas 4736286 76508
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American Fork 5844096, Utah 5549030 84003
Cedar City 5536630, Utah 5549030 84720
Farmington 5774662, Utah 5549030 84025
Logan 5777544, Utah 5549030 84321
Murray 5778755, Utah 5549030 84107
Ogden 5779206, Utah 5549030 84403
Provo 5780026, Utah 5549030 84604
Riverton 5780557, Utah 5549030 84065
Salt Lake City 5780993, Utah 5549030 84106
Salt Lake City 5780993, Utah 5549030 84112
Salt Lake City 5780993, Utah 5549030 84143
South Jordan 5781770, Utah 5549030 84009
St. George 5546220, Utah 5549030 84770
Berlin Corners 5233780, Vermont 5242283 05602
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Burlington 5234372, Vermont 5242283 05401
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Burke 4749950, Virginia 6254928 22015
Chesapeake 4752186, Virginia 6254928 23320
Gloucester 4761161, Virginia 6254928 23061
Lynchburg 4771075, Virginia 6254928 24501
McLean 4772354, Virginia 6254928 22102
Newport News 4776024, Virginia 6254928 23601
Richmond 4781708, Virginia 6254928 23229
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South Hill 4786619, Virginia 6254928 23970
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Virginia Beach 4791259, Virginia 6254928 23454
Williamsburg 4793846, Virginia 6254928 23185
Woodbridge 4794457, Virginia 6254928 22192
Bellevue 5786882, Washington 5815135 98004
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Edmonds 5793427, Washington 5815135 98026
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Renton 5808189, Washington 5815135 98055
Seattle 5809844, Washington 5815135 98109
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Seattle 5809844, Washington 5815135 98122
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Silverdale 5810490, Washington 5815135 98383
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Bridgeport 4800081, West Virginia 4826850 26330
Charleston 4801859, West Virginia 4826850 25304
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Martinsburg 4813878, West Virginia 4826850 25401
Morgantown 4815352, West Virginia 4826850 26506
Parkersburg 4817641, West Virginia 4826850 26101
Wheeling 5280854, West Virginia 4826850 26003
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Antigo 5244010, Wisconsin 5279468 54409
Appleton 5244080, Wisconsin 5279468 54911
Ashland 5244247, Wisconsin 5279468 54806
Berlin 5245497, Wisconsin 5279468 54923
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Chippewa Falls 5248511, Wisconsin 5279468 54729
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Eau Claire 5251436, Wisconsin 5279468 54701
Germantown 5254218, Wisconsin 5279468 53022
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Green Bay 5254962, Wisconsin 5279468 54301
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Johnson Creek 5257996, Wisconsin 5279468 53038
Kenosha 5258393, Wisconsin 5279468 53142
La Crosse 5258957, Wisconsin 5279468 54601
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Madison 5261457, Wisconsin 5279468 53718
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Marinette 5261852, Wisconsin 5279468 54143
Marshfield 5261969, Wisconsin 5279468 54449
Medford 5262475, Wisconsin 5279468 54451
Menomonee Falls 5262630, Wisconsin 5279468 53051
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262-257-5100
Milwaukee 5263045, Wisconsin 5279468 53209
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Milwaukee 5263045, Wisconsin 5279468 53233
Minocqua 5263156, Wisconsin 5279468 54548
Mukwonago 5263965, Wisconsin 5279468 53149
Neenah 5264223, Wisconsin 5279468 54956
Neillsville 5264241, Wisconsin 5279468 54456
New Richmond 5264475, Wisconsin 5279468 54017
Oak Creek 5265228, Wisconsin 5279468 53154
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414-805-0505
Oconomowoc 5265499, Wisconsin 5279468 53066
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262-928-7878
Oconto Falls 5265522, Wisconsin 5279468 54154
Oshkosh 5265838, Wisconsin 5279468 54904
Oshkosh 5265838, Wisconsin 5279468 54904
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Rhinelander 5268720, Wisconsin 5279468 54501
Rice Lake 5268798, Wisconsin 5279468 54868
Shawano 5272873, Wisconsin 5279468 54166
Sheboygan 5272893, Wisconsin 5279468 53081
Sheboygan 5272893, Wisconsin 5279468 53081
Stevens Point 5274644, Wisconsin 5279468 54481
Stevens Point 5274644, Wisconsin 5279468 54482
Sturgeon Bay 5274867, Wisconsin 5279468 54235-1495
Summit, Wisconsin 5279468 53066
Two Rivers 5276609, Wisconsin 5279468 54241
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Waupaca 5278083, Wisconsin 5279468 54981
Wausau 5278120, Wisconsin 5279468 54401
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Wausau 5278120, Wisconsin 5279468 54401
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Weston 5278693, Wisconsin 5279468 54476
Wisconsin Rapids 5279436, Wisconsin 5279468 54494
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715-422-7718
Wisconsin Rapids 5279436, Wisconsin 5279468 54494
More Details
- NCT ID
- NCT05174169
- Status
- Recruiting
- Sponsor
- NRG Oncology
Detailed Description
Currently, there are no biomarkers validated prospectively in randomized studies for resected colon cancer to determine need for adjuvant chemotherapy. However, circulating tumor DNA (ctDNA) shed into the bloodstream represents a highly specific and sensitive approach (especially with serial monitoring) for identifying microscopic or residual tumor cells in colon cancer patients and may outperform traditional clinical and pathological features in prognosticating risk for recurrence. Colon cancer patients who do not have detectable ctDNA (ctDNA-) are at a much lower risk of recurrence and may not need adjuvant chemotherapy. Furthermore, for colon cancer pts with detectable ctDNA (ctDNA+) who are at a very high risk of recurrence, the optimal adjuvant chemotherapy regimen has not been established. We hypothesize that for pts whose colon cancer has been resected, ctDNA status may be used to risk stratify for making decisions about adjuvant chemotherapy.