Trial of Capecitabine With or Without Irinotecan Driven by UGT1A1

Sponsor
Fudan University
Study ID
NCT02605265
Phase
PHASE3
Status
Completed

Conditions

  • Locally Advanced Rectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Radiation — RADIATION
    Pelvic Radiation: 50Gy/25Fx
  • Capecitabine — DRUG
  • Irinotecan — DRUG
  • Oxaliplatin — DRUG

Study Details

The study evaluate the addition of Irinotecan in neoadjuvant chemoradiation. Half of participants will receive capecitabine alone together with neoadjuvant CRT, followed by a cycle of XELOX, while the other will receive capecitabine and irinotecan during CRT, followed by a cycle of XELIRI. All participants will be scheduled to receive surgery 6-8 weeks after the completion of CRT, then 5 cycles of adjuvant chemotherapy of XELOX.

Key Dates

Start date
Oct 31, 2015
Status verified
Aug 2025
Primary completion
Dec 31, 2017
Completion
Jun 30, 2023

Study Design

Enrollment
356 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Capecitabine Alone
    Concurrent Chemoradiotherapy: Radiation: 50Gy/25Fx; Capecitabine: 825mg/m2 bid Monday-Friday per week Chemotherapy in Interval Between CRT and Surgery: Capecitabine: 1000mg/m2 bid d1-14; Oxaliplatin: 130mg/m2 d1 Surgery: Scheduled 6-8 weeks after the completion of CRT Adjuvant Chemotherapy: Capecitabine: 1000mg/m2 bid d1-14; Oxaliplatin: 130mg/m2 d1; q3w, 5cycles
  • Experimental: Capecitabine with Irinotecan
    Concurrent Chemoradiotherapy: Radiation: 50Gy/25Fx; Capecitabine: 625mg/m2 bid Monday-Friday per week; Irinotecan: 80mg/m2 (UGT1A1\*28 6/6) or 65mg/m2 (UGT1A1\*28 6/7) Chemotherapy in Interval Between CRT and Surgery: Capecitabine: 1000mg/m2 bid d1-14; Irinotecan: 200mg/m2 d1 Surgery: Scheduled 6-8 weeks after the completion of CRT Adjuvant Chemotherapy: Capecitabine: 1000mg/m2 bid d1-14; Oxaliplatin: 130mg/m2 d1; q3w, 5cycles

Primary Outcome Measure

Pathologic Complete Response [ Time Frame: Surgery scheduled 6-8 weeks after the end of chemoradiation ]

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