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 Genders
- 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 |
|
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314-996-5569
Washington, Missouri 63090
Site Public Contact
636-390-1600
Anaconda, Montana 59711
Billings, Montana 59101
Billings, Montana 59102
Site Public Contact
800-648-6274
Bozeman, Montana 59715
Great Falls, Montana 59405
Great Falls, Montana 59405
Kalispell, Montana 59901
Missoula, Montana 59804
Kearney, Nebraska 68847
Lincoln, Nebraska 68516
Omaha, Nebraska 68122
Omaha, Nebraska 68124
Omaha, Nebraska 68130
Omaha, Nebraska 68131
Carson City, Nevada 89703
Henderson, Nevada 89052
Henderson, Nevada 89052
Las Vegas, Nevada 89102
Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
Las Vegas, Nevada 89169
Reno, Nevada 89502
Reno, Nevada 89503
Concord, New Hampshire 03301
Site Public Contact
603-224-2556
Exeter, New Hampshire 03833
Site Public Contact
800-439-3837
Lebanon, New Hampshire 03756
Londonderry, New Hampshire 03053
Manchester, New Hampshire 03103
Site Public Contact
800-339-6484
Elizabeth, New Jersey 07207
Site Public Contact
908-994-8000
Hamilton, New Jersey 08690
Site Public Contact
609-631-6946
Jersey City, New Jersey 07302
Lakewood, New Jersey 08701
Livingston, New Jersey 07039
Long Branch, New Jersey 07740
Morristown, New Jersey 07960
Site Public Contact
973-971-5900
New Brunswick, New Jersey 08903
Site Public Contact
732-235-7356
Newark, New Jersey 07101
Site Public Contact
732-235-7356
Newark, New Jersey 07112
Somerville, New Jersey 08876
Summit, New Jersey 07902
Site Public Contact
908-522-2043
Toms River, New Jersey 08755
Albuquerque, New Mexico 87106
Albuquerque, New Mexico 87110
Las Cruces, New Mexico 88011
Rio Rancho, New Mexico 87124
Bronx, New York 10461
Brooklyn, New York 11215
Flushing, New York 11355
Glens Falls, New York 12801
Site Public Contact
518-926-6700
Greenlawn, New York 11740
Site Public Contact
516-734-8896
Lake Success, New York 11042
Site Public Contact
516-734-8896
Middletown, New York 10940
Mount Kisco, New York 10549
New York, New York 10021
Site Public Contact
516-734-8896
New York, New York 10029
New York, New York 10065
Site Public Contact
212-434-4460
New York, New York 10065
Site Public Contact
212-746-1848
Rego Park, New York 11374
Site Public Contact
718-312-3446
Rochester, New York 14621
Rochester, New York 14626
Rochester, New York 14642
Site Public Contact
585-275-5830
Sleepy Hollow, New York 10591
Site Public Contact
914-366-1600
Stony Brook, New York 11794
Site Public Contact
800-862-2215
Webster, New York 14580
Cary, North Carolina 27518
Site Public Contact
919-781-7070
Cary, North Carolina 27518
Chapel Hill, North Carolina 27599
Clinton, North Carolina 28328
Durham, North Carolina 27710
Site Public Contact
888-275-3853
Garner, North Carolina 27529
Goldsboro, North Carolina 27534
Greenville, North Carolina 27834
Hendersonville, North Carolina 28791
Jacksonville, North Carolina 28546
Raleigh, North Carolina 27607
Raleigh, North Carolina 27609
Site Public Contact
919-862-5400
Raleigh, North Carolina 27614
Winston-Salem, North Carolina 27157
Site Public Contact
336-713-6771
Bismarck, North Dakota 58501
Fargo, North Dakota 58103
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Akron, Ohio 44304
Akron, Ohio 44307
Avon, Ohio 44011
Site Public Contact
800-641-2422
Barberton, Ohio 44203
Beachwood, Ohio 44122
Beavercreek, Ohio 45431
Belpre, Ohio 45714
Boardman, Ohio 44512
Canton, Ohio 44708
Site Public Contact
888-293-4673
Centerville, Ohio 45459
Centerville, Ohio 45459
Chardon, Ohio 44024
Chillicothe, Ohio 45601
Cincinnati, Ohio 45219
Cincinnati, Ohio 45220
Cincinnati, Ohio 45236
Cincinnati, Ohio 45242
Cincinnati, Ohio 45247
Cincinnati, Ohio 45255
Cleveland, Ohio 44106
Cleveland, Ohio 44109
Cleveland, Ohio 44111
Cleveland, Ohio 44195
Columbus, Ohio 43210
Columbus, Ohio 43213
Columbus, Ohio 43219
Columbus, Ohio 43222
Dayton, Ohio 45409
Dayton, Ohio 45409
Site Public Contact
937-276-8320
Dayton, Ohio 45415
Dayton, Ohio 45415
Findlay, Ohio 45840
Findlay, Ohio 45840
Findlay, Ohio 45840
Franklin, Ohio 45005-1066
Franklin, Ohio 45005
Gahanna, Ohio 43230
Greenville, Ohio 45331
Greenville, Ohio 45331
Site Public Contact
937-569-7515
Greenville, Ohio 45331
Grove City, Ohio 43123
Independence, Ohio 44131
Kettering, Ohio 45409
Kettering, Ohio 45429
Lancaster, Ohio 43130
Lima, Ohio 45801
Mansfield, Ohio 44906
Marietta, Ohio 45750
Mayfield Heights, Ohio 44124
Medina, Ohio 44256
Mentor, Ohio 44060
Middleburg Heights, Ohio 44130
Mount Vernon, Ohio 43050
New Albany, Ohio 43054
Newark, Ohio 43055
Newark, Ohio 43055
Parma, Ohio 44129
Perrysburg, Ohio 43551
Portsmouth, Ohio 45662
Ravenna, Ohio 44266
Sandusky, Ohio 44870
Springfield, Ohio 45504
Springfield, Ohio 45504
Steubenville, Ohio 43952
Site Public Contact
888-874-7000
Strongsville, Ohio 44136
Sylvania, Ohio 43560
Toledo, Ohio 43606
Toledo, Ohio 43608
Toledo, Ohio 43623
Toledo, Ohio 43623
Troy, Ohio 45373
Troy, Ohio 45373
Wadsworth, Ohio 44281
Warrensville Heights, Ohio 44122
Warren, Ohio 44484
West Chester, Ohio 45069
Westerville, Ohio 43081
Westlake, Ohio 44145
Wooster, Ohio 44691
Youngstown, Ohio 44501
Zanesville, Ohio 43701
Lawton, Oklahoma 73505
Site Public Contact
877-231-4440
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73109
Oklahoma City, Oklahoma 73120
Site Public Contact
405-752-3402
Oklahoma City, Oklahoma 73142
Site Public Contact
405-773-6613
Tulsa, Oklahoma 74146
Site Public Contact
918-505-3200
Clackamas, Oregon 97015
Clackamas, Oregon 97015
Newberg, Oregon 97132
Ontario, Oregon 97914
Oregon City, Oregon 97045
Portland, Oregon 97213
Portland, Oregon 97225
Portland, Oregon 97227
Allentown, Pennsylvania 18103
Altoona, Pennsylvania 16601
Beaver, Pennsylvania 15009
Bethlehem, Pennsylvania 18017
Butler, Pennsylvania 16001
Carlisle, Pennsylvania 17015
Chambersburg, Pennsylvania 17201
Site Public Contact
717-217-6020
Cranberry Township, Pennsylvania 16066
East Stroudsburg, Pennsylvania 18301
Ephrata, Pennsylvania 17522
Site Public Contact
717-721-4840
Erie, Pennsylvania 16505
Erie, Pennsylvania 16544
Site Public Contact
814-452-5000
Farrell, Pennsylvania 16121
Gettysburg, Pennsylvania 17325
Site Public Contact
877-441-7957
Greensburg, Pennsylvania 15601
Site Public Contact
724-838-1900
Harrisburg, Pennsylvania 17109
Hazleton, Pennsylvania 18201
Hershey, Pennsylvania 17033-0850
Indiana, Pennsylvania 15701
Jefferson Hills, Pennsylvania 15025
Johnstown, Pennsylvania 15901
Site Public Contact
814-534-4724
Lancaster, Pennsylvania 17601
Lancaster, Pennsylvania 17602
Lebanon, Pennsylvania 17042
McKeesport, Pennsylvania 15132
Site Public Contact
412-647-8073
Mechanicsburg, Pennsylvania 17050
Monroeville, Pennsylvania 15146
Site Public Contact
412-858-7746
Monroeville, Pennsylvania 15146
Moon, Pennsylvania 15108
N. Huntingdon, Pennsylvania 15642
Natrona Heights, Pennsylvania 15065
Natrona Heights, Pennsylvania 15065
Site Public Contact
724-230-3030
New Castle, Pennsylvania 16105
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19114
Philadelphia, Pennsylvania 19148
Pittsburgh, Pennsylvania 15212
Site Public Contact
877-284-2000
Pittsburgh, Pennsylvania 15213
Site Public Contact
412-647-2811
Pittsburgh, Pennsylvania 15215
Site Public Contact
412-784-4900
Pittsburgh, Pennsylvania 15219
Site Public Contact
800-533-8762
Pittsburgh, Pennsylvania 15224
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412-578-5000
Pittsburgh, Pennsylvania 15232
Site Public Contact
412-647-8073
Pittsburgh, Pennsylvania 15232
Site Public Contact
412-621-2334
Pittsburgh, Pennsylvania 15237
Site Public Contact
412-367-6454
Pittsburgh, Pennsylvania 15243
Site Public Contact
412-502-3920
Sellersville, Pennsylvania 18960
Seneca, Pennsylvania 16346
Site Public Contact
814-676-7900
Uniontown, Pennsylvania 15401
Washington, Pennsylvania 15301
West Chester, Pennsylvania 19380
West Reading, Pennsylvania 19611
Site Public Contact
610-988-9323
Wexford, Pennsylvania 15090
Williamsport, Pennsylvania 17754
Willow Grove, Pennsylvania 19090
York, Pennsylvania 17403
Site Public Contact
717-741-9229
York, Pennsylvania 17403
Site Public Contact
877-441-7957
York, Pennsylvania 17403
Site Public Contact
877-441-7957
York, Pennsylvania 17408
Site Public Contact
717-724-6760
Westerly, Rhode Island 02891
Boiling Springs, South Carolina 29316
Site Public Contact
864-241-6251
Easley, South Carolina 29640
Greenville, South Carolina 29605
Site Public Contact
864-241-6251
Greenville, South Carolina 29605
Site Public Contact
864-241-6251
Greenville, South Carolina 29615
Site Public Contact
864-241-6251
Greer, South Carolina 29650
Site Public Contact
864-241-6251
Greer, South Carolina 29651
Seneca, South Carolina 29672
Site Public Contact
864-241-6251
Spartanburg, South Carolina 29303
Aberdeen, South Dakota 57401
Pierre, South Dakota 57501
Rapid City, South Dakota 57701
Sioux Falls, South Dakota 57104
Sioux Falls, South Dakota 57105
Sioux Falls, South Dakota 57117-5134
Collierville, Tennessee 38017
Germantown, Tennessee 38138
Memphis, Tennessee 38120
Nashville, Tennessee 37232
Site Public Contact
800-811-8480
Austin, Texas 78701
Site Public Contact
512-324-7991
Austin, Texas 78712
Conroe, Texas 77384
Dallas, Texas 75235
Dallas, Texas 75237
Dallas, Texas 75390
Edinburg, Texas 78539
Fort Worth, Texas 76104
Galveston, Texas 77555-0565
Houston, Texas 77026-1967
Site Public Contact
713-566-5000
Houston, Texas 77030
Houston, Texas 77030
Site Public Contact
713-873-2000
Houston, Texas 77030
Houston, Texas 77079
League City, Texas 77573
Richardson, Texas 75080
Sugar Land, Texas 77478
Temple, Texas 76508
Site Public Contact
254-724-5407
American Fork, Utah 84003
Cedar City, Utah 84720
Farmington, Utah 84025
Logan, Utah 84321
Murray, Utah 84107
Ogden, Utah 84403
Provo, Utah 84604
Riverton, Utah 84065
Saint George, Utah 84770
Salt Lake City, Utah 84106
Salt Lake City, Utah 84112
Salt Lake City, Utah 84143
South Jordan, Utah 84009
Berlin, Vermont 05602
Site Public Contact
802-225-5400
Burlington, Vermont 05401
Saint Johnsbury, Vermont 05819
Burke, Virginia 22015
Chesapeake, Virginia 23320
Gloucester, Virginia 23061
Lynchburg, Virginia 24501
McLean, Virginia 22102
Site Public Contact
240-632-4284
Newport News, Virginia 23601
Richmond, Virginia 23229
Richmond, Virginia 23235
Richmond, Virginia 23298
South Hill, Virginia 23970
Suffolk, Virginia 23435
Virginia Beach, Virginia 23454
Williamsburg, Virginia 23185
Woodbridge, Virginia 22192
Bellevue, Washington 98004
Site Public Contact
425-454-2148
Kennewick, Washington 99336
Kirkland, Washington 98034
Site Public Contact
425-899-6000
Renton, Washington 98055
Seattle, Washington 98109
Site Public Contact
800-804-8824
Seattle, Washington 98133
Site Public Contact
206-606-5800
Seattle, Washington 98195
Site Public Contact
800-804-8824
Silverdale, Washington 98383
Yakima, Washington 98902
Bridgeport, West Virginia 26330
Martinsburg, West Virginia 25401
Morgantown, West Virginia 26506
Parkersburg, West Virginia 26101
Wheeling, West Virginia 26003
Site Public Contact
304-243-6442
Antigo, Wisconsin 54409
Appleton, Wisconsin 54911
Ashland, Wisconsin 54806
Berlin, Wisconsin 54923
Burlington, Wisconsin 53105
Chippewa Falls, Wisconsin 54729
Cudahy, Wisconsin 53110
Eau Claire, Wisconsin 54701
Eau Claire, Wisconsin 54701
Germantown, Wisconsin 53022
Grafton, Wisconsin 53024
Green Bay, Wisconsin 54301
Green Bay, Wisconsin 54303
Green Bay, Wisconsin 54311
Janesville, Wisconsin 53548
Johnson Creek, Wisconsin 53038
Kenosha, Wisconsin 53142
La Crosse, Wisconsin 54601
Ladysmith, Wisconsin 54848
Madison, Wisconsin 53792
Marinette, Wisconsin 54143
Marshfield, Wisconsin 54449
Medford, Wisconsin 54451
Milwaukee, Wisconsin 53209
Milwaukee, Wisconsin 53215
Milwaukee, Wisconsin 53233
Minocqua, Wisconsin 54548
Mukwonago, Wisconsin 53149
Neenah, Wisconsin 54956
Neillsville, Wisconsin 54456
New Richmond, Wisconsin 54017
Oconomowoc, Wisconsin 53066
Site Public Contact
262-928-7878
Oconto Falls, Wisconsin 54154
Oshkosh, Wisconsin 54904
Oshkosh, Wisconsin 54904
Racine, Wisconsin 53406
Rhinelander, Wisconsin 54501
Rice Lake, Wisconsin 54868
Shawano, Wisconsin 54166
Sheboygan, Wisconsin 53081
Stevens Point, Wisconsin 54481
Stevens Point, Wisconsin 54482
Sturgeon Bay, Wisconsin 54235-1495
Summit, Wisconsin 53066
Two Rivers, Wisconsin 54241
Waukesha, Wisconsin 53188
Waupaca, Wisconsin 54981
Wausau, Wisconsin 54401
Site Public Contact
877-405-6866
Wausau, Wisconsin 54401
Wauwatosa, Wisconsin 53226
West Allis, Wisconsin 53227
Weston, Wisconsin 54476
Wisconsin Rapids, Wisconsin 54494
Site Public Contact
715-422-7718
Wisconsin Rapids, Wisconsin 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.