CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 322 enrolled
Drug / intervention
Adjuvant FL +1 moredrug
Likely dose
Adjuvant FL 380 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/NCT00807911
NCT00807911Phase 2Completed
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Randomized Phase II Study of Adjuvant Chemotherapy With 5-FU/Leucovorin vs. Oxaliplatin/5-FU/Leucovorin After Preoperative Chemoradiotherapy With Fluoropyrimidines Followed by Surgery in Patients With Locally Advanced Rectal Cancer

Asan Medical Center·interventional·Posted Dec 12, 2008·Updated Oct 23, 2024

In Brief

A Phase 2 clinical trial evaluating Adjuvant FL and Adjuvant FOLFOX for Rectal Cancer. Completed, enrolled 322 participants across 6 sites.

Detailed Summary

The purpose of this study is to evaluate the disease-free survival in patients with locally advanced rectal cancer treated with preoperative chemoradiotherapy with fluoropyrimidines and surgery followed by adjuvant combination chemotherapy with oxaliplatin/5-FU/Leucovorin vs 5-FU/Leucovorin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRectal Cancer
CountriesSouth Korea
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 12, 2008
Enrollment StartNov 1, 2008
Primary CompletionJun 30, 2013
Study CompletionSep 5, 2014
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 17.6 years ago

Interventions

Adjuvant FLdrug

5-Fluorouracil 380 mg/m2, leucovorin 20 mg/m2 on D1-5 q 4 weeks X 4 cycles

Adjuvant FOLFOXdrug

oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 on D1, 5-Fluorouracil bolus 400 mg/m2 on D1, 5-Fluorouracil continuous infusion 2400 mg/m2 for 46 hours q 2 weeks X 8 cycles