CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
preoperative induction chemotherapy in combination with bevacizumab followed by combined radiochemotherapy with capecitabinedrug
Likely dose
preoperative induction chemotherapy in combination with bevacizumab followed by combined radiochemotherapy with capecitabine 1000mgfrom 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/NCT01434147
NCT01434147Phase 2Completed
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Preoperative Induction Chemotherapy in Combination With Bevacizumab Followed by Combined Chemoradiotherapy in Locally Advanced Rectal Cancer With High Risk of Recurrence- Phase II Pilot Study With Preoperative Administration of Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avastin) Followed by Capecitabine (Xeloda) Plus Radiotherapy (RTx)

Austrian Breast & Colorectal Cancer Study Group·interventional·Posted Sep 14, 2011·Updated Mar 7, 2014

In Brief

A Phase 2 clinical trial evaluating preoperative induction chemotherapy in combination with bevacizumab followed by combined radiochemotherapy with capecitabine for Rectal Cancer. Completed, enrolled 25 participants across 7 sites.

Detailed Summary

Phase II pilot study of a preoperative induction chemotherapy in combination with Bevacizumab followed by combined radiochemotherapy for patients with locally advanced rectal carcinoma

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRectal Cancer
CountriesAustria
CollaboratorsHoffmann-La Roche

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 14, 2011
Enrollment StartOct 1, 2011
Primary CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.8 years ago

Interventions

preoperative induction chemotherapy in combination with bevacizumab followed by combined radiochemotherapy with capecitabinedrug

Therapy start: Capecitabine 1000mg/ m² bid during 14 days(d1-14), oxaliplatin 130mg/m² and Bevacizumab 7.5mg/kg body weight d1, repetition day 22 and 43 (3 cycles) Radiotherapy: Followed by 5 x 5 days 1.8 Gy after 1 week of concluded 3rd cycle of induction chemotherapy Chemotherapy: Capecitabine 825 mg/m2 bid (on each therapy day of first 4 therapy weeks)