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

Conditions

• Adenocarcinoma of the Rectum
• Stage II Rectal Cancer
• Stage III Rectal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• oxaliplatin — DRUG
  Given IV
• fluorouracil — DRUG
  Given IV
• leucovorin calcium — DRUG
  Given IV
• bevacizumab — DRUG
  Given IV

Study Details

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.

Key Dates

First listed

Mar 17, 2006

Start date

May 11, 2006

Status verified

Jun 2023

Primary completion

Apr 30, 2015

Completion

Feb 11, 2019

Study Design

Enrollment

355 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm I
  Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses.
• Experimental: Arm II
  Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I.

Primary Outcome Measure

5-year Overall Survival Rate [ Time Frame: 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 ]

Locations (600)

Find similar trials in Mobile, AL

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