At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 39 enrolled
Drug / intervention
Aflibercept +3 moredrug
Likely dose
Not stated in 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.
A Phase II Study of 5-Fluorouracil (5-FU), Aflibercept, and Radiation for the Preoperative and Adjuvant Treatment of Patients With Stage II/III Rectal Cancer
In Brief
A Phase 2 clinical trial evaluating Radiation, Aflibercept, and 2 other interventions for Rectal Cancer. Completed, enrolled 39 participants across 11 sites.
Detailed Summary
The purpose of this Phase II study will be to investigate the antiangiogenic agent, aflibercept, in combination with chemoradiation as preoperative treatment for patients with stage II/III rectal cancer, followed by 4 months of FOLFOX6 plus aflibercept adjuvantly.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRectal Cancer
CountriesUnited States
CollaboratorsSanofi
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 2012
Enrollment StartJan 2013
Primary CompletionSep 2015
TodayJul 2026
First PostedDec 17, 2012
Enrollment StartJan 1, 2013
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 13.5 years ago
Interventions
Radiationradiation
Afliberceptdrug
Surgeryprocedure
Abdominoperineal or low anterior resection with total mesorectal excision, per standard treatment guidelines
FOLFOX6drug