The study evaluates the addition of Chinese Herbal Compound Dendrobium Huoshanense Granules to capecitabine and irinotecan in neoadjuvant chemoradiation(CRT) in locally advanced rectal cancer. Half of participants will receive CRT with Dendrobium Huoshanense Granules, while the others will receive CRT with placebo. We will evaluate whether Dendrobium Huoshanense Granules can enhance the immune function and alleviate symptoms caused by the tumor and CRT .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
210
3g tid per day for 5weeks
50Gy/25Fx
625mg/m2 bid Monday-Friday per week
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: twice weekly during the neoadjuvant chemotherapy (5 weeks)
Impact of participants' quality of life during treatment as assessed by EQ-5D questionnaire
Time frame: once weekly during the neoadjuvant chemotherapy (5 weeks)
Impact of participants' quality of life during treatment as assessed by EORTC-QLQ-C30 questionnaire
Time frame: once weekly during the neoadjuvant chemotherapy (5 weeks)
ORR(objective response rate) includes CR(complete rate) and PR(partial rate)
Time frame: Surgery scheduled 6-8 weeks after the end of chemoradiation
Number of the concurrent chemotherapy cycles that patients can receive during radiotherapy
Time frame: once weekly during neoadjuvant chemoradiation(5 weeks,each cycle is one week)
Zhen Zhang, MD
CONTACT
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80mg/m2 (UGT1A1\*28 6/6) or 65mg/m2 (UGT1A1\*28 6/7)
3g tid per day for 5weeks