A Phase II Randomized Study of the Protection Effect of Chinese Herbal Compound Dendrobium Huoshanense Granules in NCRT for Patients With Locally Advanced Rectal Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0
研究概览
简要总结
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 .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pathological confirmed rectum adenocarcinoma
- •clinical stage T3-4 and/or N+
- •the distance from anal verge less than 10 cm
- •without distance metastases
- •performance status score: 0~1
- •UGT1A1*28 6/6 or 6/7
- •without previous anti-cancer therapy
- •able to follow the protocol during the study period
- •sign the inform consent
排除标准
- •Pregnant or breastfeeding women
- •Those with other history of malignant disease in the past 5 years, except for cured skin cancer and cervical carcinoma in situ
- •If there is an uncontrolled history of epilepsy, central nervous system disease or mental disorder, the investigator may determine that the clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance.
- •Clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring medication intervention (see appendix 12), or a history of myocardial infarction in the last 12 months
- •Organ transplantation requires immunosuppressive therapy
- •Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases
- •Subject blood routine and biochemical indicators do not meet the following criteria: hemoglobin ≥ 90g / L; absolute neutrophil count (ANC) ≥ 1.5 × 109 / L; Alanine transaminase (ALT), aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal; alkaline phosphatase (ALP) ≤2.5 times the normal upper limit; serum total bilirubin <1.5 times the normal upper limit; serum creatinine <1 times the normal upper limit; serum albumin ≥ 30g / L
- •Anyone who is allergic to any research medication
- •DPD deficiency
- •UGT1A1*28 7/7
研究组 & 干预措施
CRT with Dendrobium Huoshanense
Dendrobium Huoshanense Granules: 3g tid per day for 5weeks
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.
干预措施: Dendrobium Huoshanense Granules (Drug)
CRT with Dendrobium Huoshanense
Dendrobium Huoshanense Granules: 3g tid per day for 5weeks
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.
干预措施: Pelvic Radiation (Radiation)
CRT with Dendrobium Huoshanense
Dendrobium Huoshanense Granules: 3g tid per day for 5weeks
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.
干预措施: Capecitabine (Drug)
CRT with Dendrobium Huoshanense
Dendrobium Huoshanense Granules: 3g tid per day for 5weeks
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.
干预措施: Irinotecan (Drug)
CRT with Placebo
Placebo: 3g tid per day for 5weeks
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.
干预措施: Pelvic Radiation (Radiation)
CRT with Placebo
Placebo: 3g tid per day for 5weeks
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.
干预措施: Capecitabine (Drug)
CRT with Placebo
Placebo: 3g tid per day for 5weeks
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.
干预措施: Irinotecan (Drug)
CRT with Placebo
Placebo: 3g tid per day for 5weeks
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.
干预措施: Placebo (Other)
结局指标
主要结局
the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0
时间窗: twice weekly during the neoadjuvant chemotherapy (5 weeks)
次要结局
- Impact of participants' quality of life during treatment as assessed by EORTC-QLQ-C30 questionnaire(once weekly during the neoadjuvant chemotherapy (5 weeks))
- ORR(objective response rate) includes CR(complete rate) and PR(partial rate)(Surgery scheduled 6-8 weeks after the end of chemoradiation)
- Impact of participants' quality of life during treatment as assessed by EQ-5D questionnaire(once weekly during the neoadjuvant chemotherapy (5 weeks))
- Number of the concurrent chemotherapy cycles that patients can receive during radiotherapy(once weekly during neoadjuvant chemoradiation(5 weeks,each cycle is one week))