Bevacizumab, Radiation Therapy, and Combination Chemotherapy in Treating Patients Who Are Undergoing Surgery for Locally Advanced Nonmetastatic Rectal Cancer
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- National Cancer Institute (NCI)
- Study ID
- NCT00321685
- Phase
- PHASE2
- Status
- Completed
Conditions
- Rectal Adenocarcinoma
- Stage II Rectal Cancer AJCC v7
- Stage III Rectal Cancer AJCC v7
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Bevacizumab — BIOLOGICALGiven IV
- Capecitabine — DRUGGiven PO
- Fluorouracil — DRUGGiven IV
- Leucovorin Calcium — DRUGGiven IV
- Oxaliplatin — DRUGGiven IV
- Radiation Therapy — RADIATIONUndergo radiotherapy
- Therapeutic Conventional Surgery — PROCEDUREUndergo surgical resection
Study Details
This phase II trial studies how well giving bevacizumab, radiation therapy, and combination chemotherapy works in treating patients who are undergoing surgery for locally advanced nonmetastatic rectal cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as capecitabine, may make tumor cells more sensitive to radiation therapy. Drugs used in chemotherapy, such as capecitabine, oxaliplatin, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with radiation therapy and combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving bevacizumab together with combination chemotherapy after surgery may kill any tumor cells that remain after surgery.
Key Dates
- First listed
- May 4, 2006
- Start date
- Jul 25, 2006
- Status verified
- Mar 2019
- Primary completion
- Aug 12, 2013
- Completion
- Feb 11, 2019
Study Design
- Enrollment
- 57 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (bevacizumab and chemoradiotherapy)See Detailed Description
Primary Outcome Measure
Pathologic Complete Response Rate [ Time Frame: Assessed at surgery time ]
Locations (107)
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