TerminatedPhase 3

Postoperative Chemotherapy With or Without Bevacizumab for Patients With Stage II or III Rectal Cancer

Stopped: The study was terminated before reaching its accrual goal due to slow accrual.

United States, Canada, Peru355 participantsStarted 2006-05-11

Plain-language summary

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 or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving more than one drug (combination chemotherapy) together with bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet known whether oxaliplatin, leucovorin, and fluorouracil is more effective with or without bevacizumab in treating rectal cancer. This randomized phase III trial is studying combination chemotherapy to see how well it works with or without bevacizumab in treating patients who have had surgery for stage II or stage III rectal cancer.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histologically confirmed adenocarcinoma of the rectum meeting 1 of the following clinical (e.g., before neoadjuvant therapy) or pathologic staging criteria: * T3, N+, M0 * T3, N0, M0 * T4, N0, M0 * Any T, N1-2, M0 * T4, N0-2, M0 disease must meet 1 of the following criteria: * Clinically fixed tumor on rectal examination with tumor adherent to the pelvic sidewall or sacrum * Hydronephrosis on Computed Tomography (CT) scan or Intravenous Pyelogram (IVP) * Ureteric or bladder invasion as documented by cystoscopy and cytology or biopsy * Invasion into prostate * Vaginal or uterine involvement * Must have undergone complete tumor resection \>= 28 days ago and able to begin treatment by day 56 * Must have undergone concurrent neoadjuvant chemoradiotherapy\* * NOTE: \*Neoadjuvant chemoradiotherapy received on protocol NSABP-R-04 allowed provided it met these criteria * Must have undergone prior radiotherapy at 40-55.8 Gy\*\* AND received 1 of the following chemotherapy regimens: * Continuous infusion of fluorouracil with or without oxaliplatin; fluorouracil and leucovorin calcium * Capecitabine with or without oxaliplatin; capecitabine with or without oxaliplatin OR a continuous infusion of fluorouracil with or without oxaliplatin received on protocol NSABP-R-04 * NOTE: \*\*Intensity-modulated radiotherapy allowed * ECOG performance status 0-1 * Platelet count \>= 100,000/mm\^3 * Absolute granulocyte count \>= 1,500/mm\^3 * Bilir…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

5-year Overall Survival Rate

Timeframe: Follow-up assessments performed every 3 months for patients < 2 years from randomization, every 6 months for patients 2-5 years from randomization, and every 12 months for patients 5-10 years from randomization

Trial details

NCT IDNCT00303628

SponsorECOG-ACRIN Cancer Research Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2015-04

Results submitted2016-01-28

View on ClinicalTrials.gov More Adenocarcinoma of the Rectum trials