Overview

This trial is active, not recruiting.

Condition advanced colorectal cancer
Treatments oxaliplatin, bevacizumab, capecitabine, radiotherapy
Phase phase 2
Target VEGF
Sponsor Universitaire Ziekenhuizen Leuven
Start date June 2009
End date March 2014
Trial size 80 participants
Trial identifier NCT00828672, 2007 - 007177 - 23, MO19051, s51104 - ML5194

Summary

Phase II clinical trial, open-label, randomized, two arms, multicentre (possibly multinational). Academic, investigator initiated.

To assess the activity of bevacizumab (AvastinTM) in combination with capecitabine (XelodaTM) and radiation therapy with or without oxaliplatin (EloxatinTM) in the pre-operative treatment of locally advanced rectal cancer, followed by TME (total mesorectal excision).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Oxaliplatin, Bevacizumab and Capecitabine concurrently with radiotherapy.
oxaliplatin Eloxatin
Administered on days 15,22,29,36 en 43; 50 mg/m2
bevacizumab Avastin
Administered on days 1,15,29 and 43 ; 5mg/kg
capecitabine Xeloda
825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy
radiotherapy
Total dose 45Gy
(Active Comparator)
Bevacizumab and Capecitabine concurrently with radiotherapy
bevacizumab Avastin
Administered on days 1,15,29 and 43 ; 5mg/kg
capecitabine Xeloda
825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy
radiotherapy
Total dose 45Gy

Primary Outcomes

Measure
Pathologic complete response (ypT0N0) rate
time frame: 4 months

Secondary Outcomes

Measure
Histopathologic R0 and negative CRM resection rate
time frame: 4 months
Pathologic downstaging (yp T0-2 N0) rate
time frame: 4 months
Tumor regression grade
time frame: 3 months
Clinical response rate
time frame: 3 months
Toxicity
time frame: continuous up to 1 year
Loco-regional and distant recurrence rates
time frame: up to 5 years
Progression-free and overall survival
time frame: up to 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patient is at least 18 years of age - Good organ function - Locally advanced (according to RECIST criteria) adenocarcinoma of the rectum Exclusion Criteria: - Evidence of distant metastases - Contraindication for bevacizumab - Pregnant or breastfeeding women.

Additional Information

Official title A Randomized Phase II Study of Bevacizumab, Capecitabine and Radiation Therapy With or Without Oxaliplatin in the Preoperative Treatment of Locally Advanced Rectal Cancer
Principal investigator Eric Van Cutsem, Prof. Dr.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Universitaire Ziekenhuizen Leuven.