NCT03702985

Radiation-protection Effect of Amifostine in Locally Advanced Rectal Cancer

A Phase II Trial of Capecitabine and Irinotecan With or Without Amifostine in Neoadjuvant Chemoradiotherapy in Locally Advanced Rectal Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Locally Advanced Rectal Cancer

Interventions

Type	Name	Description
RADIATION	Radiation	Pelvic Radiation: 50Gy/25Fx
DRUG	Capecitabine	625mg/m2 bid Monday-Friday per week
DRUG	Irinotecan	80mg/m2 (UGT1A1\*28 6/6) or 65mg/m2 (UGT1A1\*28 6/7)
DRUG	Amifostine	400mg/m2 per week

Timeline

• Start date: 2018-05-28
• Primary completion: 2019-11-01
• Completion: 2020-03-01
• First posted: 2018-10-11
• Last updated: 2019-01-23

Locations

1 site across 1 country: China