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 colon adenocarcinoma (T1-3, N1/N1c) with R0 resection accordingly to AJCC 8th edition criteria. NOTE: Patients with pathologic stages II or IIIC colon adenocarcinoma with R0 resection who have a commercially obtained Signatera™ ctDNA+ve assay result post-operatively meeting all timelines and eligibility requirements otherwise, are eligible for enrollment and inclusion in Cohort B. No radiographic evidence of overt metastatic disease within 28 days prior to 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 IIIA or Stage IIIB colon cancer must have central testing for ctDNA using the Signatera™ assay by Natera. NOTE: Patients with stage IIIA or IIIB colon cancer who otherwise meet eligibility criteria and have had ctDNA status checked with the Signatera™ assay as routine care outside of the study, are allowed to be enrolled, and will be retested and placed in either Cohort A or Cohort B depending on the central ctDNA testing result. NOTE: Patients with stage II or IIIC colon cancer who otherwise meet eligibility criteria and have had ctDNA status checked with the Signatera™ assay as routine care outside of the study AND have a ctDNA+ve result, are allowed to be enrolled. Patients will have central ctDNA testing, confirmed to be ctDNA+ve, and placed in Cohort B. 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 study entry must be no more than 60 days. Availability and provision of adequate surgical tumor tissue for molecular diagnostics and confirmatory profiling. Adequate hematologic function within 28 days before study entry defined as follows: - Absolute neutrophil count (ANC) must be greater than or equal to 1500/mm3; - 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 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 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) 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 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 study entry must be negative (for women of childbearing potential only). Adequate hematologic function within 28 days before randomization defined as follows: - Absolute neutrophil count (ANC) must be greater than or equal to 1500/mm3; - 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 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 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). Other invasive malignancy within 5 years before 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 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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New Brunswick, New Jersey 08903
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732-235-7356
Newark, New Jersey 07101
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732-235-7356
Newark, New Jersey 07112
Somerville, New Jersey 08876
Toms River, New Jersey 08755
Albuquerque, New Mexico 87102
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
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518-926-6700
Greenlawn, New York 11740
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516-734-8896
Lake Success, New York 11042
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516-734-8896
Middletown, New York 10940
Mount Kisco, New York 10549
New York, New York 10021
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516-734-8896
New York, New York 10029
New York, New York 10065
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212-434-4460
New York, New York 10065
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212-746-1848
Rego Park, New York 11374
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718-312-3446
Rochester, New York 14642
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585-275-5830
Sleepy Hollow, New York 10591
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914-366-1600
Stony Brook, New York 11794
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800-862-2215
Webster, New York 14580
Cary, North Carolina 27518
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919-781-7070
Cary, North Carolina 27518
Chapel Hill, North Carolina 27599
Clinton, North Carolina 28328
Durham, North Carolina 27710
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888-275-3853
Garner, North Carolina 27529
Goldsboro, North Carolina 27534
Hendersonville, North Carolina 28791
Jacksonville, North Carolina 28546
Raleigh, North Carolina 27607
Raleigh, North Carolina 27609
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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 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
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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
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937-276-8320
Dayton, Ohio 45409
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
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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
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419-226-9617
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 45505
Steubenville, Ohio 43952
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888-874-7000
Strongsville, Ohio 44136
Toledo, Ohio 43608
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
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73109
Oklahoma City, Oklahoma 73120
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405-752-3402
Oklahoma City, Oklahoma 73142
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405-773-6613
Tulsa, Oklahoma 74146
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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
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717-217-6020
Cranberry Township, Pennsylvania 16066
East Stroudsburg, Pennsylvania 18301
Ephrata, Pennsylvania 17522
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717-721-4840
Erie, Pennsylvania 16505
Erie, Pennsylvania 16544
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814-452-5000
Farrell, Pennsylvania 16121
Gettysburg, Pennsylvania 17325
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877-441-7957
Greensburg, Pennsylvania 15601
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724-838-1900
Harrisburg, Pennsylvania 17109
Hazleton, Pennsylvania 18201
Hershey, Pennsylvania 17033-0850
Indiana, Pennsylvania 15701
Jefferson Hills, Pennsylvania 15025
Johnstown, Pennsylvania 15901
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814-534-4724
Lebanon, Pennsylvania 17042
McKeesport, Pennsylvania 15132
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412-647-8073
Mechanicsburg, Pennsylvania 17050
Monroeville, Pennsylvania 15146
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412-858-7746
Monroeville, Pennsylvania 15146
Moon, Pennsylvania 15108
N. Huntingdon, Pennsylvania 15642
Natrona Heights, Pennsylvania 15065
Natrona Heights, Pennsylvania 15065
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724-230-3030
New Castle, Pennsylvania 16105
Philadelphia, Pennsylvania 19104
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800-474-9892
Philadelphia, Pennsylvania 19107
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800-789-7366
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19114
Philadelphia, Pennsylvania 19148
Pittsburgh, Pennsylvania 15212
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877-284-2000
Pittsburgh, Pennsylvania 15213
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412-647-2811
Pittsburgh, Pennsylvania 15215
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412-784-4900
Pittsburgh, Pennsylvania 15219
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800-533-8762
Pittsburgh, Pennsylvania 15224
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412-578-5000
Pittsburgh, Pennsylvania 15232
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412-647-8073
Pittsburgh, Pennsylvania 15232
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412-621-2334
Pittsburgh, Pennsylvania 15237
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412-367-6454
Pittsburgh, Pennsylvania 15243
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412-502-3920
Sellersville, Pennsylvania 18960
Seneca, Pennsylvania 16346
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814-676-7900
Uniontown, Pennsylvania 15401
Washington, Pennsylvania 15301
West Chester, Pennsylvania 19380
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610-431-5297
West Reading, Pennsylvania 19611
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610-988-9323
Wexford, Pennsylvania 15090
Williamsport, Pennsylvania 17754
Willow Grove, Pennsylvania 19090
York, Pennsylvania 17403
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877-441-7957
York, Pennsylvania 17403
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877-441-7957
York, Pennsylvania 17408
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717-724-6760
Westerly, Rhode Island 02891
Aberdeen, South Dakota 57401
Pierre, South Dakota 57501
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
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800-811-8480
Austin, Texas 78701
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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
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713-566-5000
Houston, Texas 77030
Houston, Texas 77030
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713-873-2000
Houston, Texas 77030
Houston, Texas 77079
League City, Texas 77573
Richardson, Texas 75080
Sugar Land, Texas 77478
Farmington, Utah 84025
Salt Lake City, Utah 84112
South Jordan, Utah 84009
Berlin, Vermont 05602
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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
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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
Bremerton, Washington 98310
Kennewick, Washington 99336
Renton, Washington 98055
Yakima, Washington 98902
Martinsburg, West Virginia 25401
Morgantown, West Virginia 26506
Parkersburg, West Virginia 26101
Wheeling, West Virginia 26003
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304-243-6442
Antigo, Wisconsin 54409
Appleton, Wisconsin 54911
Berlin, Wisconsin 54923
Burlington, Wisconsin 53105
Chippewa Falls, Wisconsin 54729
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
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800-622-8922
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.