CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 57 enrolled
Drug / intervention
Bevacizumab +6 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00321685
NCT00321685Phase 2Completed

Phase II Study of Preoperative Radiation With Concurrent Capecitabine, Oxaliplatin and Bevacizumab Followed by Surgery and Postoperative 5-FU, Leucovorin, Oxaliplatin (FOLFOX) and Bevacizumab in Patients With Locally Advanced Rectal Cancer

National Cancer Institute (NCI)·interventional·Posted May 4, 2006·Updated Mar 27, 2019

In Brief

A Phase 2 clinical trial evaluating Bevacizumab, Capecitabine, and 5 other interventions for Rectal Adenocarcinoma and 2 related conditions. Completed, enrolled 57 participants across 107 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 4, 2006
Enrollment StartJul 25, 2006
Primary CompletionAug 12, 2013
Study CompletionFeb 11, 2019
TodayJul 2, 2026
Enrollment to primary: 7.0 yearsPosted 20.2 years ago

Interventions

Bevacizumabbiological

Given IV

Capecitabinedrug

Given PO

Fluorouracildrug

Given IV

Leucovorin Calciumdrug

Given IV

Oxaliplatindrug

Given IV

Radiation Therapyradiation

Undergo radiotherapy

Therapeutic Conventional Surgeryprocedure

Undergo surgical resection