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Spots Global Cancer Trial Database for Chemoradiation for Locally Advanced and Low Rectal Cancers: Avastin-Capecitabine-Oxaliplatin-Radiation REctal Cancer Trial

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Trial Identification

Brief Title: Chemoradiation for Locally Advanced and Low Rectal Cancers: Avastin-Capecitabine-Oxaliplatin-Radiation REctal Cancer Trial

Official Title: Phase II Study of Chemoradiation for Locally Advanced and Low Rectal Cancers: Avastin-Capecitabine-Oxaliplatin-Radiation REctal Cancer Trial

Study ID: NCT00386828

Interventions

Bevacizumab:

Study Description

Brief Summary: This phase II study will evaluate the effect of bevacizumab, capecitabine and oxaliplatin with radiation on rectal cancer. Researchers will also evaluate the tolerability (how it makes the patient feel) and safety of this combination by watching for harmful side-effects.It is hoped that by adding bevacizumab to the capecitabine/oxaliplatin treatment in combination with radiation before surgery will improve response rate.

Detailed Description: Improved pre-operative therapy is required in the management of high risk rectal cancer in order to decrease local recurrence and increase the rate of sphincter sparing surgery. Capecitabine, oxaliplatin and bevacizumab represent new systemic agents and have been given safely in phase I and II trials concurrently with radiation with promising improvements in pCR rates of 15 -24% compared to historic rates of 8-14% achieved with 5-FU alone. Improvements in pCR rates have not been associated with an increase in post-operative complication rates. A trial of all three of these agents is justified due to their enhanced efficacy when given in combination as well as their non-overlapping treatment toxicity profile. This is a one-armed, multi-centred, Phase II study in patients with T3/4 locally advanced and T3/4 low lying rectal cancer, to study the efficacy and safety of the addition of bevacizumab to a regimen of capecitabine and oxaliplatin in combination with pre-operative radiation.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Tom Baker Cancer Centre, Calgary, Alberta, Canada

Cross Cancer Institute, Edmonton, Alberta, Canada

BCCA - Centre for Southern Interior, Kelowna, British Columbia, Canada

BC Cancer Agency - Vancouver Centre, Vancouver, British Columbia, Canada

CancerCare Manitoba, Winnipeg, Manitoba, Canada

Sunnybrook Odette Cancer Centre, Toronto, Ontario, Canada

Contact Details

Name: Hagen Kennecke, MD

Affiliation: BC Cancer Agency -Vancouver Centre

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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