CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
Bevacizumab +4 moredrug
Likely dose
Bevacizumab 5 mg/kgfrom 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/NCT01858649
NCT01858649Phase 2Completed

Randomized Phase 2 Study Comparing Pathological Responses on Colorectal Cancer Metastases After Preoperative Treatment Combining Bevacizumab With FOLFOX or FOLFIRI

Cliniques universitaires Saint-Luc- Université Catholique de Louvain·interventional·Posted May 21, 2013·Updated Oct 22, 2020

In Brief

A Phase 2 clinical trial evaluating Metastases resection, Bevacizumab, and 3 other interventions for Metastatic Colorectal Cancer. Completed, enrolled 60 participants across 11 sites.

Detailed Summary

The study is designed to analyze the pathological tumor response on resected colorectal cancer metastases after preoperative treatment with bevacizumab combined with FOLFOX or FOLFIRI regimen in a prospective cohort and to correlate this response with patient's outcome.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 21, 2013
Enrollment StartMay 1, 2013
Primary CompletionMay 1, 2019
TodayJul 2, 2026
Enrollment to primary: 6 yearsPosted 13.1 years ago

Interventions

Metastases resectionprocedure

Surgery of colorectal cancer metastases will be proceeded after 3 to 6 cycles of chemotherapy ( folfox or folfiri) + bevacizumab .

Bevacizumabdrug

Bevacizumab 5 mg/kg in 100 ml NaCl 0.9% IV infusion 3 to 5 cycles. No bevacizumab for ultimate cycle .

5 FUdrug

Leucovorin L (levoleucovorin) 200 mg/m2 (or folinic acid 400 mg/m²) in 250 ml glucose 5%, IV infusion 3 to 6 cycles 5-FU bolus 400 mg/m2, IV bolus 3 to 6 cycles 5-FU continuous infusion 2400 mg/m2, 46-hour cont. IV infusion 3 to 6 cycles

Oxaliplatindrug

oxaliplatin 85 mg/m² in 150 ml NaCl 0.9%, IV infusion 3 to 6 cycles

Irinotecandrug

Irinotecan 180 mg/m² in 150 ml NaCl 0.9%, IV infusion 3 to 6 cycles