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Adjuvant Chemotherapy After Preoperative Chemoradiotherapy to Treat Rectal Cancer

NCT00807911 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 322

Last updated 2024-10-23

Study results available
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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.

Conditions

Interventions

DRUG

Adjuvant FL

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

DRUG

Adjuvant FOLFOX

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

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Tae Won Kim, Professor · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-01
Primary Completion
2013-06-30
Completion
2014-09-05

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00807911 on ClinicalTrials.gov