Radiation-protection Effect of Amifostine in Locally Advanced Rectal Cancer

Sponsor
Fudan University
Study ID
NCT03702985
Phase
PHASE2
Status
Unknown

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
    625mg/m2 bid Monday-Friday per week
  • Irinotecan — DRUG
    80mg/m2 (UGT1A1\*28 6/6) or 65mg/m2 (UGT1A1\*28 6/7)
  • Amifostine — DRUG
    400mg/m2 per week

Study Details

The study evaluates the addition of Amifostine to capecitabine and irinotecan in neoadjuvant chemoradiation(CRT) in locally advanced rectal cancer. Half of participants will receive capecitabine and along with neoadjuvant radiotherapy, followed by a cycle of XELIRI, while the others will receive capecitabine and irinotecan added by amifostine 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 it will depends which regimens the patient would receive according to his or her pathological results.

Key Dates

Start date
May 28, 2018
Status verified
Oct 2018
Primary completion
Nov 1, 2019
Completion
Mar 1, 2020

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Capecitabine and Irinotecan without Amifostine
    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: depends on patients pathological review.
  • Experimental: Capecitabine and Irinotecan with Amifostine
    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) Amifostine: 400mg/m2 per week 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: depends on patients pathological review.

Primary Outcome Measure

the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0 [ Time Frame: during neoadjuvant chemoradiation. ]

Central Contacts

Related Studies