CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 84 enrolled
Drug / intervention
Oxaliplatin +3 moredrug
Likely dose
Oxaliplatin 50 mg/m2from 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/NCT00828672
NCT00828672Phase 2Completed
CompareCT.gov

A Randomized Phase II Study of Bevacizumab, Capecitabine and Radiation Therapy With or Without Oxaliplatin in the Preoperative Treatment of Locally Advanced Rectal Cancer

Universitaire Ziekenhuizen KU Leuven·interventional·Posted Jan 26, 2009·Updated Jul 10, 2019

In Brief

A Phase 2 clinical trial evaluating Oxaliplatin, Bevacizumab, and 2 other interventions for Locally Advanced Rectal Cancer. Completed, enrolled 84 participants across 9 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLocally Advanced Rectal Cancer
CountriesBelgium
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 26, 2009
Enrollment StartJun 1, 2009
Primary CompletionMar 1, 2014
Study CompletionMar 1, 2019
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 17.4 years ago

Interventions

Oxaliplatindrug

Administered on days 15,22,29,36 en 43; 50 mg/m2

Bevacizumabdrug

Administered on days 1,15,29 and 43 ; 5mg/kg

Capecitabinedrug

825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy

radiotherapyradiation

Total dose 45Gy