The purpose of this study is to determine the pathological complete response rate of addition of bevacizumab to induction therapy (xelox) and concomitant treatment (capecitabine+radiotherapy), followed by surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
1. -Induction treatment. 4 cycles (every 3 weeks) of bevacizumab (7,5mg/kg day 1) + oxaliplatin (130mg/m2 day 1) + capecitabine (1000mg/m2/12h days 1-14) 2. -Concomitant (CT+RT) treatment (3 weeks later): bevacizumab (5mg/kg day 1 of 1st, 3th and 5th weeks) + capecitabine (825mg/m2/12h daily during radiotherapy treatment) + radiotherapy (45Gy (25fractions of 1,8Gy/day over 5weeks) followed by boost 5.4Gy (1,8Gy/day over 3days)) 3. -Surgery (6-8 weeks after last bevacizumab dose) 4. -Adjuvant treatment: It will be individual decision of each investigator, but it's recommended 4 cycles of XELOX (equal dose at induction treatment)
ACROSS
Barcelona, Spain
RECRUITINGPathologic Complete Response Rate
Time frame: after concomitant CT-RT treatment
Complete Resection (R0) Rate
Time frame: after surgery
Disease Free Survival
Time frame: from complete response to relapse or disease-related death
Time to Failure Treatment
Time frame: from first treatment dose to drop out of the study
Metastatic or Local Recurrence
Time frame: during study
Toxicity Evaluation
Time frame: during study
Surgical Morbility
Time frame: during surgery
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