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Fluorouracil, Leucovorin, and Oxaliplatin With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II or Stage III Colon Cancer

Primary Purpose

Colon Adenocarcinoma, Stage IIA Colon Cancer AJCC v7, Stage IIB Colon Cancer AJCC v7

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Bevacizumab
Fluorouracil
Leucovorin Calcium
Oxaliplatin
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients must consent to be in the study and must have signed and dated an IRB approved consent form conforming to federal and institutional guidelines Randomization must occur during the three-week interval beginning on postoperative day 29 and ending on postoperative day 50 The distal extent of the tumor must be >= 12 cm from the anal verge on endoscopy; if the patient is not a candidate for endoscopy, then the distal extent of the tumor must be >= 12 cm from the anal verge as determined by surgical examination The patient must have had an en bloc complete gross resection of tumor (curative resection) by open laparotomy or laparoscopically-assisted colectomy; 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 Patients must have histologically confirmed adenocarcinoma of the colon that meets one of the criteria below: Stage II carcinoma (T3,4 N0 M0); the tumor invades through the muscularis propria into the subserosa or into non-peritonealized pericolic or perirectal tissues (T3); or directly invades other organs or structures, and/or perforates visceral peritoneum (T4) Stage III carcinoma (any T N1,2 M0); the tumor has invaded to any depth, with involvement of regional lymph nodes Patients with T4 tumors that have involved an adjacent structure (e.g., bladder, small intestine, ovary, etc.) by direct extension from the primary tumor are eligible if all of the following conditions are met: All or a portion of the adjacent structure was removed en bloc with the primary tumor In the opinion of the surgeon, all grossly visible tumor was completely resected ("curative resection") Histologic evaluation by the pathologist confirms the margins of the resected specimen are not involved by malignant cells; and Local radiation therapy will not be utilized Patients with more than one synchronous primary colon tumor are eligible; (staging classification will be based on the more advanced primary tumor) Patients must have an ECOG performance status of 0 or 1 At the time of randomization, postoperative absolute granulocyte count (AGC) must be >= 1500/mm^3 (or < 1500/mm^3, if in the opinion of the investigator, this represents an ethnic or racial variation of normal) At the time of randomization, the postoperative platelet count must be >= 100,000/mm^3 Bilirubin must be =< ULN for the lab unless the patient has a chronic grade 1 bilirubin elevation due to Gilbert's disease or similar syndrome due to slow conjugation of bilirubin Alkaline phosphatase must be < 2.5 x ULN for the lab AST must be < 1.5 x ULN for the lab If AST is > ULN, serologic testing for hepatitis B and C must be performed and results must be negative Serum creatinine =< 1.5 x ULN for the lab Urine protein/creatinine (UPC) ratio of < 1.0; patients with a UPC ratio >= 1.0 must undergo a 24-hour urine collection, which must be an adequate collection and must demonstrate < 1 gm of protein in the 24-hour urine collection in order to participate in the study Patients with prior malignancies, including colorectal cancers, are eligible if they have been disease-free for >= 5 years and are deemed by their physician to be at low risk for recurrence; patients with squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum that have been effectively treated are eligible, even if these conditions were diagnosed within 5 years prior to randomization Exclusion Criteria: Patients < 18 years old Colon tumor other than adenocarcinoma, i.e., sarcoma, lymphoma, carcinoid, etc Rectal tumors, i.e. a tumor located < 12 cm from the anal verge on endoscopy, or by surgical exam if the patient is not a candidate for endoscopy Isolated, distant, or non-contiguous intra-abdominal metastases, even if resected Any systemic or radiation therapy initiated for this malignancy Any significant bleeding that is not related to the primary colon tumor within 6 months before study entry Serious or non-healing wound, skin ulcers, or bone fracture Gastroduodenal ulcer(s) determined by endoscopy to be active Invasive procedures defined as follows: Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization Anticipation of need for major surgical procedures during the course of the study Core biopsy or other minor procedure, excluding placement of a vascular access device, within 7 days prior to randomization Uncontrolled blood pressure defined as > 150/90 mmHg History of TIA or CVA History of arterial thrombotic event within 12 months before study entry Symptomatic peripheral vascular disease PT/INR > 1.5, unless the patient is on therapeutic doses of warfarin. If so, the following criteria must be met for enrollment: The subject must have an in-range INR (usually between 2 and 3) on a stable dose of warfarin The subject must not have active bleeding or a pathological condition that is associated with a high-risk of bleeding Concomitant halogenated antiviral agents Clinically significant peripheral neuropathy at the time of randomization (defined in the NCI Common Terminology Criteria for Adverse Events Version 3.0 [CTCAE v3.0] as grade 2 or greater neurosensory or neuromotor toxicity) Non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude any of the study therapy drugs; specifically excluded are the following cardiac conditions: New York Heart Association Class III or IV cardiac disease History of myocardial infarction within 12 months before study entry Unstable angina within 12 months before study entry; and Symptomatic arrhythmia History of chronic or persistent viral hepatitis or other chronic liver disease Pregnancy or lactation at the time of proposed randomization; eligible patients of reproductive potential (both sexes) must agree to use adequate contraceptive methods during study therapy and for at least 3 months after the completion of bevacizumab Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements

Sites / Locations

  • National Surgical Adjuvant Breast and Bowel Project

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm I (mFOLFOX6)

Arm II (bevacizumab, mFOLFOX6)

Arm Description

Patients receive adjuvant chemotherapy comprising concurrent oxaliplatin and leucovorin calcium IV over 2 hours on day 1. Patients also receive adjuvant fluorouracil IV over 2-4 minutes on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 14 days for 12 courses in the absence of disease progression or unacceptable toxicity.

Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive adjuvant oxaliplatin, leucovorin calcium, and fluorouracil as in arm I. Treatment repeats every 14 days for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of adjuvant chemotherapy, patients continue to receive bevacizumab alone every 14 days for 6 months in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Disease-free Survival
Where events are defined as recurrence, second primary cancer, or death from any cause

Secondary Outcome Measures

Survival
Percentage of patients who did not experience an event where events are defined as death from any cause.

Full Information

First Posted
November 9, 2004
Last Updated
July 17, 2019
Sponsor
National Cancer Institute (NCI)
Collaborators
NSABP Foundation Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00096278
Brief Title
Fluorouracil, Leucovorin, and Oxaliplatin With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II or Stage III Colon Cancer
Official Title
A Phase III Clinical Trial Comparing Infusional 5-Fluorouracil (5-FU), Leucovorin, and Oxaliplatin (mFOLFOX6) Every Two Weeks With Bevacizumab to the Same Regimen Without Bevacizumab for the Treatment of Patients With Resected Stages II and III Carcinoma of the Colon
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 15, 2004 (Actual)
Primary Completion Date
March 12, 2009 (Actual)
Study Completion Date
December 31, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)
Collaborators
NSABP Foundation Inc

4. Oversight

5. Study Description

Brief Summary
This randomized phase III trial is studying giving oxaliplatin, leucovorin, and fluorouracil together with bevacizumab to see how well it works compared to oxaliplatin, leucovorin, and fluorouracil alone in treating patients who have undergone surgery for stage II or stage III colon cancer. Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Bevacizumab may also stop the growth of tumor cells by stopping blood flow to the tumor. Giving chemotherapy together with bevacizumab may kill more tumor cells. It is not yet known whether treatment with oxaliplatin, leucovorin, and fluorouracil is more effective with or without bevacizumab in treating patients who have undergone surgery for colon cancer.
Detailed Description
PRIMARY OBJECTIVES: I. To compare the relative efficacy of mFOLFOX6 + bevacizumab with that of mFOLFOX6 alone in prolonging disease-free survival (DFS). SECONDARY OBJECTIVES: I. To compare the relative efficacy of mFOLFOX6 + bevacizumab with that of mFOLFOX6 alone in prolonging survival (S). TERTIARY OBJECTIVES: I. To assess the persistence of proteinuria following the discontinuation of bevacizumab. II. To correlate the development of proteinuria with clinical sequelae. III. To evaluate the risk factors for development of proteinuria. IV. To determine the effect of discontinuation of bevacizumab on hypertension. V. To estimate the incidence of delayed vascular events such as myocardia infarction, CNS ischemia, and thrombosis in patients receiving chemotherapy + bevacizumab. VI. To assess the effect of bevacizumab on ovarian function in premenopausal women. VII. To assess the incidence rate of immunogenicity and examine post-treatment serum levels of bevacizumab in patients receiving bevacizumab. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive adjuvant chemotherapy comprising concurrent oxaliplatin and leucovorin calcium IV over 2 hours on day 1. Patients also receive adjuvant fluorouracil IV over 2-4 minutes on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 14 days for 12 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive adjuvant oxaliplatin, leucovorin calcium, and fluorouracil as in arm I. Treatment repeats every 14 days for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of adjuvant chemotherapy, patients continue to receive bevacizumab alone every 14 days for 6 months in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Adenocarcinoma, Stage IIA Colon Cancer AJCC v7, Stage IIB Colon Cancer AJCC v7, Stage IIC Colon Cancer AJCC v7, Stage IIIA Colon Cancer AJCC v7, Stage IIIB Colon Cancer AJCC v7, Stage IIIC Colon Cancer AJCC v7

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2710 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (mFOLFOX6)
Arm Type
Active Comparator
Arm Description
Patients receive adjuvant chemotherapy comprising concurrent oxaliplatin and leucovorin calcium IV over 2 hours on day 1. Patients also receive adjuvant fluorouracil IV over 2-4 minutes on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 14 days for 12 courses in the absence of disease progression or unacceptable toxicity.
Arm Title
Arm II (bevacizumab, mFOLFOX6)
Arm Type
Experimental
Arm Description
Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive adjuvant oxaliplatin, leucovorin calcium, and fluorouracil as in arm I. Treatment repeats every 14 days for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of adjuvant chemotherapy, patients continue to receive bevacizumab alone every 14 days for 6 months in the absence of disease progression or unacceptable toxicity.
Intervention Type
Biological
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF rhuMAb, Avastin, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Bevacizumab Biosimilar CBT 124, Bevacizumab Biosimilar FKB238, Bevacizumab Biosimilar HD204, Bevacizumab Biosimilar HLX04, Bevacizumab Biosimilar IBI305, Bevacizumab Biosimilar LY01008, Bevacizumab Biosimilar MIL60, Bevacizumab Biosimilar QL 1101, Bevacizumab Biosimilar SCT501, HD204, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF, SCT501
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Fluorouracil
Other Intervention Name(s)
5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-FU, 5FU, AccuSite, Carac, Fluoro Uracil, Fluouracil, Flurablastin, Fluracedyl, Fluracil, Fluril, Fluroblastin, Ribofluor, Ro 2-9757, Ro-2-9757
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Leucovorin Calcium
Other Intervention Name(s)
Adinepar, Calcifolin, Calcium (6S)-Folinate, Calcium Folinate, Calcium Leucovorin, Calfolex, Calinat, Cehafolin, Citofolin, Citrec, citrovorum factor, Cromatonbic Folinico, Dalisol, Disintox, Divical, Ecofol, Emovis, Factor, Citrovorum, Flynoken A, Folaren, Folaxin, FOLI-cell, Foliben, Folidan, Folidar, Folinac, Folinate Calcium, folinic acid, Folinic Acid Calcium Salt Pentahydrate, Folinoral, Folinvit, Foliplus, Folix, Imo, Lederfolat, Lederfolin, Leucosar, leucovorin, Rescufolin, Rescuvolin, Tonofolin, Wellcovorin
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
1-OHP, Ai Heng, Aiheng, Dacotin, Dacplat, Diaminocyclohexane Oxalatoplatinum, Eloxatin, Eloxatine, JM-83, Oxalatoplatin, Oxalatoplatinum, RP 54780, RP-54780, SR-96669
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Disease-free Survival
Description
Where events are defined as recurrence, second primary cancer, or death from any cause
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Survival
Description
Percentage of patients who did not experience an event where events are defined as death from any cause.
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
Bevacizumab Immunogenicity and Post-treatment Serum Levels of Bevacizumab in Patients Receiving Bevacizumab
Time Frame
Group 2: Pre-therapy, every 2 weeks during chemotherapy/bevacizumab therapy, every 6 weeks during bevacizumab therapy and at 3 and 6 months after completion of bevacizumab therapy
Title
Ovarian Function in Premenopausal Women as Measured by Serum Ovarian Function Test
Time Frame
Group 2: Measured pre-therapy and then every 6 months for 2 years following randomization
Title
Delayed Vascular Events Such as Myocardial Infarction, Central Nervous System (CNS) Ischemia, and Thrombosis in Patients Receiving Chemotherapy + Bevacizumab
Time Frame
Events measured regularly during chemotherapy and bevacizumab therapy
Title
As Measured by Blood Pressure and Antihypertensive Medication Hypertension
Time Frame
Group 2, every 3 months for one year post treatment
Title
The Risk Factors for Development of Proteinuria
Time Frame
For Groups 1 and 2 at the end of every 3 cycles of chemotherapy plus or minus bevacizumab; for Group 2 patients, every 6 weeks for 6 months. If UPC ratio is greater than or equal to 1.0 at the end of therapy then test every 3 months for 12 months
Title
Proteinuria With Clinical Sequelae
Time Frame
For Groups 1 and 2 at the end of every 3 cycles of chemotherapy plus or minus bevacizumab; for Group 2 patients, every 6 weeks for 6 months. If UPC ratio is greater than or equal to 1.0 at the end of therapy then test every 3 months for 12 months
Title
Proteinuria After Completion of Bevacizumab
Time Frame
For Groups 1 and 2 at the end of every 3 cycles of chemotherapy plus or minus bevacizumab; for Group 2 patients, every 6 weeks for 6 months. If UPC ratio is greater than or equal to 1.0 at the end of therapy then test every 3 months for 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must consent to be in the study and must have signed and dated an IRB approved consent form conforming to federal and institutional guidelines Randomization must occur during the three-week interval beginning on postoperative day 29 and ending on postoperative day 50 The distal extent of the tumor must be >= 12 cm from the anal verge on endoscopy; if the patient is not a candidate for endoscopy, then the distal extent of the tumor must be >= 12 cm from the anal verge as determined by surgical examination The patient must have had an en bloc complete gross resection of tumor (curative resection) by open laparotomy or laparoscopically-assisted colectomy; 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 Patients must have histologically confirmed adenocarcinoma of the colon that meets one of the criteria below: Stage II carcinoma (T3,4 N0 M0); the tumor invades through the muscularis propria into the subserosa or into non-peritonealized pericolic or perirectal tissues (T3); or directly invades other organs or structures, and/or perforates visceral peritoneum (T4) Stage III carcinoma (any T N1,2 M0); the tumor has invaded to any depth, with involvement of regional lymph nodes Patients with T4 tumors that have involved an adjacent structure (e.g., bladder, small intestine, ovary, etc.) by direct extension from the primary tumor are eligible if all of the following conditions are met: All or a portion of the adjacent structure was removed en bloc with the primary tumor In the opinion of the surgeon, all grossly visible tumor was completely resected ("curative resection") Histologic evaluation by the pathologist confirms the margins of the resected specimen are not involved by malignant cells; and Local radiation therapy will not be utilized Patients with more than one synchronous primary colon tumor are eligible; (staging classification will be based on the more advanced primary tumor) Patients must have an ECOG performance status of 0 or 1 At the time of randomization, postoperative absolute granulocyte count (AGC) must be >= 1500/mm^3 (or < 1500/mm^3, if in the opinion of the investigator, this represents an ethnic or racial variation of normal) At the time of randomization, the postoperative platelet count must be >= 100,000/mm^3 Bilirubin must be =< ULN for the lab unless the patient has a chronic grade 1 bilirubin elevation due to Gilbert's disease or similar syndrome due to slow conjugation of bilirubin Alkaline phosphatase must be < 2.5 x ULN for the lab AST must be < 1.5 x ULN for the lab If AST is > ULN, serologic testing for hepatitis B and C must be performed and results must be negative Serum creatinine =< 1.5 x ULN for the lab Urine protein/creatinine (UPC) ratio of < 1.0; patients with a UPC ratio >= 1.0 must undergo a 24-hour urine collection, which must be an adequate collection and must demonstrate < 1 gm of protein in the 24-hour urine collection in order to participate in the study Patients with prior malignancies, including colorectal cancers, are eligible if they have been disease-free for >= 5 years and are deemed by their physician to be at low risk for recurrence; patients with squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum that have been effectively treated are eligible, even if these conditions were diagnosed within 5 years prior to randomization Exclusion Criteria: Patients < 18 years old Colon tumor other than adenocarcinoma, i.e., sarcoma, lymphoma, carcinoid, etc Rectal tumors, i.e. a tumor located < 12 cm from the anal verge on endoscopy, or by surgical exam if the patient is not a candidate for endoscopy Isolated, distant, or non-contiguous intra-abdominal metastases, even if resected Any systemic or radiation therapy initiated for this malignancy Any significant bleeding that is not related to the primary colon tumor within 6 months before study entry Serious or non-healing wound, skin ulcers, or bone fracture Gastroduodenal ulcer(s) determined by endoscopy to be active Invasive procedures defined as follows: Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization Anticipation of need for major surgical procedures during the course of the study Core biopsy or other minor procedure, excluding placement of a vascular access device, within 7 days prior to randomization Uncontrolled blood pressure defined as > 150/90 mmHg History of TIA or CVA History of arterial thrombotic event within 12 months before study entry Symptomatic peripheral vascular disease PT/INR > 1.5, unless the patient is on therapeutic doses of warfarin. If so, the following criteria must be met for enrollment: The subject must have an in-range INR (usually between 2 and 3) on a stable dose of warfarin The subject must not have active bleeding or a pathological condition that is associated with a high-risk of bleeding Concomitant halogenated antiviral agents Clinically significant peripheral neuropathy at the time of randomization (defined in the NCI Common Terminology Criteria for Adverse Events Version 3.0 [CTCAE v3.0] as grade 2 or greater neurosensory or neuromotor toxicity) Non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude any of the study therapy drugs; specifically excluded are the following cardiac conditions: New York Heart Association Class III or IV cardiac disease History of myocardial infarction within 12 months before study entry Unstable angina within 12 months before study entry; and Symptomatic arrhythmia History of chronic or persistent viral hepatitis or other chronic liver disease Pregnancy or lactation at the time of proposed randomization; eligible patients of reproductive potential (both sexes) must agree to use adequate contraceptive methods during study therapy and for at least 3 months after the completion of bevacizumab Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen J Allegra
Organizational Affiliation
NSABP Foundation Inc
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Surgical Adjuvant Breast and Bowel Project
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212-5234
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33356421
Citation
Cohen R, Taieb J, Fiskum J, Yothers G, Goldberg R, Yoshino T, Alberts S, Allegra C, de Gramont A, Seitz JF, O'Connell M, Haller D, Wolmark N, Erlichman C, Zaniboni A, Lonardi S, Kerr R, Grothey A, Sinicrope FA, Andre T, Shi Q. Microsatellite Instability in Patients With Stage III Colon Cancer Receiving Fluoropyrimidine With or Without Oxaliplatin: An ACCENT Pooled Analysis of 12 Adjuvant Trials. J Clin Oncol. 2021 Feb 20;39(6):642-651. doi: 10.1200/JCO.20.01600. Epub 2020 Dec 23.
Results Reference
derived
PubMed Identifier
31811950
Citation
Penney KL, Banbury BL, Bien S, Harrison TA, Hua X, Phipps AI, Sun W, Song M, Joshi AD, Alberts SR, Allegra CJ, Atkins J, Colangelo LH, George TJ, Goldberg RM, Lucas PC, Nair SG, Shi Q, Sinicrope FA, Wolmark N, Yothers G, Peters U, Newcomb PA, Chan AT. Genetic Variant Associated With Survival of Patients With Stage II-III Colon Cancer. Clin Gastroenterol Hepatol. 2020 Nov;18(12):2717-2723.e3. doi: 10.1016/j.cgh.2019.11.046. Epub 2019 Dec 4.
Results Reference
derived
PubMed Identifier
31268130
Citation
Taieb J, Shi Q, Pederson L, Alberts S, Wolmark N, Van Cutsem E, de Gramont A, Kerr R, Grothey A, Lonardi S, Yoshino T, Yothers G, Sinicrope FA, Zaanan A, Andre T. Prognosis of microsatellite instability and/or mismatch repair deficiency stage III colon cancer patients after disease recurrence following adjuvant treatment: results of an ACCENT pooled analysis of seven studies. Ann Oncol. 2019 Sep 1;30(9):1466-1471. doi: 10.1093/annonc/mdz208.
Results Reference
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PubMed Identifier
28006055
Citation
Sinicrope FA, Shi Q, Allegra CJ, Smyrk TC, Thibodeau SN, Goldberg RM, Meyers JP, Pogue-Geile KL, Yothers G, Sargent DJ, Alberts SR. Association of DNA Mismatch Repair and Mutations in BRAF and KRAS With Survival After Recurrence in Stage III Colon Cancers : A Secondary Analysis of 2 Randomized Clinical Trials. JAMA Oncol. 2017 Apr 1;3(4):472-480. doi: 10.1001/jamaoncol.2016.5469.
Results Reference
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PubMed Identifier
23233715
Citation
Allegra CJ, Yothers G, O'Connell MJ, Sharif S, Petrelli NJ, Lopa SH, Wolmark N. Bevacizumab in stage II-III colon cancer: 5-year update of the National Surgical Adjuvant Breast and Bowel Project C-08 trial. J Clin Oncol. 2013 Jan 20;31(3):359-64. doi: 10.1200/JCO.2012.44.4711. Epub 2012 Dec 10.
Results Reference
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PubMed Identifier
21997132
Citation
Yothers G, Sargent DJ, Wolmark N, Goldberg RM, O'Connell MJ, Benedetti JK, Saltz LB, Dignam JJ, Blackstock AW; ACCENT Collaborative Group. Outcomes among black patients with stage II and III colon cancer receiving chemotherapy: an analysis of ACCENT adjuvant trials. J Natl Cancer Inst. 2011 Oct 19;103(20):1498-506. doi: 10.1093/jnci/djr310. Epub 2011 Oct 12.
Results Reference
derived

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Fluorouracil, Leucovorin, and Oxaliplatin With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II or Stage III Colon Cancer

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