A Study of Neoadjuvant Chemoradiotherapy With 5-FU/Leucovorin (FL) vs. TS-1/Irinotecan in Patients With Locally Advanced Rectal Cancer

Sponsor
Yonsei University
Study ID
NCT01269216
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 5-FU with leucovorin — DRUG
    5FU 400mg/m2/day with Leucovorin 20mg/m2/day IV on day 1 and day29
  • TS-1 with Irinotecan — DRUG
    Irinotecan 40mg/m2/day IV on day 1,8,15,22 and 29 with TS-1 70mg/m2/day PO for 25 days

Study Details

This is an open-label, randomized phase II study. Patients will be randomly assigned to either FL or TS-1/irinotecan preoperative chemotherapy regimens by stratification. Patients in FL group will be treated with bolus injections of 5-FU 400 mg/m2/day and LV 20 mg/m2/day for 3 consecutive days every 4 weeks for 2 cycles, and patients in TS-1/irinotecan will be treated with irinotecan 40 mg/m2/day on days 1, 8, 15, 22, 29. TS-1 at a dose of 35mg/m2 was administered orally twice a day after a meal on the day of irradiation (Monday-Friday) concurrent with radiotherapy.

Key Dates

Start date
Oct 31, 2008
Status verified
Jan 2015
Primary completion
Sep 30, 2014
Completion
Sep 30, 2014

Study Design

Enrollment
136 participants (actual)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 5-FU with leucovorin
  • Active Comparator: TS-1 with Irinotecan

Primary Outcome Measure

pathologic complete response rate [ Time Frame: every 4 weeks in FL group, every 2 weeks in TS-1/irinotecan group ]

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