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

Running, not enrolling · Phase 3

Conditions studied: Colon Adenocarcinoma, Stage IIA Colon Cancer AJCC v7, Stage IIB Colon Cancer AJCC v7, Stage IIC Colon Cancer AJCC v7

In brief

This randomized phase III trial studies oxaliplatin, leucovorin, fluorouracil, and bevacizumab to see how well they work compared to oxaliplatin, leucovorin, and fluorouracil in treating patients who have undergone surgery for stage II colon cancer. Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving combination chemotherapy together with bevacizumab is more effective than combination chemotherapy alone in treating colon cancer.

Key facts

Study ID

NCT00217737

Run by

National Cancer Institute (NCI)

People needed

2431

Starts

2005-09-06

Expected to finish

2027-04-11

Last updated by the study team

2026-05-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• STEP 1: INITIAL REGISTRATION
• The distal extent of the tumor must be >= 12 cm from the anal verge on endoscopy; if this distance was not confirmed on endoscopy pre-operatively, then the distal extent of the tumor must be >= 12 cm from the anal verge as determined by surgical examination; colonoscopy should be performed postoperatively for those unable to have a preoperative colonoscopy to guarantee there are no synchronous lesions
• Patients must have paraffin-embedded tumor specimen available for evaluation of microsatellite instability and loss of heterozygosity at 18q, to determine high risk versus low risk
• High-risk patients will be randomized to treatment Arms A or B
• Low-risk patients will be registered to Arm C for observation
• NOTE: Every effort should be made to submit blocks (tumor and normal mucosa) to the Principal Coordinates Analysis (PCO) immediately; blocks CANNOT be accepted after day 50 (post surgery) in order to allow for molecular assessment
• Specific laboratory requirements for Step 2 must be obtained within 2 weeks prior to Step 2 randomization
• Patients must not have synchronous tumors
• Patients must not have appendiceal tumors
• Patients must not have a history of inflammatory bowel disease (IBD)
• Patients with hereditary non-polyposis colorectal cancer (HNPCC) are eligible
• Patients must have no history of isolated, distant, or non-contiguous intra-abdominal metastases, even if restricted
• Patients must have histologically confirmed adenocarcinoma of the colon that meets the criteria below:
• Stage II adenocarcinoma (pT3/pT4a/pT4b pN0 M0 according to the definitions of the American Joint Committee on Cancer, 7th Edition, 2010): the tumor invades through the muscularis propria into pericolic tissues (pT3), penetrates to the surface of the visceral peritoneum (pT4a), or directly invades other organs or structures (pT4b); patients with mesenteric tumor deposits or satellites without identifiable residual lymph node in the absence of lymph node involvement are now designated pN1c, rather than pT3; patients with such tumor deposits are not eligible for E5202; patients must have had a complete resection (R0 resection)
• Patients must have >= 8 lymph nodes evaluated and reported
• Patients must not have presented with clinical complete obstruction or perforation of the bowel
• Patients must not have had any systemic or radiation therapy initiated for this malignancy
• Patients must not have a previous or concurrent malignancy; exceptions are made for patients who meet any of the following conditions:
• Non-melanoma skin cancer, in situ cervical cancer, or breast cancer in situ
• Prior malignancy completely excised or removed and patient has been continuously disease free for > 5 years
• Patients with completely excised or removed breast cancer and disease free > 5 years, regardless of the continuation of hormonal therapy
• Patients with previous radiation therapy (RT) to the pelvic region will be ineligible
• Patients must be ≥ 18 years old
• Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• STEP 2: RANDOMIZATION (HIGH RISK PATIENTS - ARMS A AND B ONLY)

Where it is running

• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
• Clearview Cancer Institute — Huntsville, Alabama, United States
• Mobile Infirmary Medical Center — Mobile, Alabama, United States
• Providence Hospital — Mobile, Alabama, United States
• Providence Alaska Medical Center — Anchorage, Alaska, United States
• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• Banner University Medical Center - Tucson — Tucson, Arizona, United States
• Mercy Hospital Fort Smith — Fort Smith, Arkansas, United States
• NEA Baptist Memorial Hospital — Jonesboro, Arkansas, United States
• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States
• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California, United States
• Mills-Peninsula Medical Center — Burlingame, California, United States
• East Bay Radiation Oncology Center — Castro Valley, California, United States
• Eden Hospital Medical Center — Castro Valley, California, United States
• Valley Medical Oncology Consultants-Castro Valley — Castro Valley, California, United States
• John Muir Medical Center-Concord — Concord, California, United States
• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• Bay Area Breast Surgeons Inc — Emeryville, California, United States
• Valley Medical Oncology Consultants-Fremont — Fremont, California, United States
• Washington Hospital — Fremont, California, United States
• Saint Jude Medical Center — Fullerton, California, United States
• Glendale Memorial Hospital and Health Center — Glendale, California, United States
• Marin Cancer Care Inc — Greenbrae, California, United States
• Marin General Hospital — Greenbrae, California, United States
• Northeast Alabama Regional Medical Center — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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