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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
160
Pelvic Radiation: 50Gy/25Fx
625mg/m2 bid Monday-Friday per week
80mg/m2 (UGT1A1\*28 6/6) or 65mg/m2 (UGT1A1\*28 6/7)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGthe morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0
Time frame: during neoadjuvant chemoradiation.
Impact of participants' quality of life during treatment as assessed by EQ-5D questionnaire and EORTC-QLQ-C30 questionnaire
Time frame: during neoadjuvant chemoradiation.
pathological response rate
Time frame: Surgery scheduled 6-8 weeks after the end of chemoradiation.
the morbidity of late radiation proctitis
Time frame: late radiation proctitis is measured 9 months after the end of chemoradiation.
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400mg/m2 per week