A Study of Chinese Herbal Compound Dendrobium Huoshanense Granules in NCRT for Patients With Locally Advanced Rectal Cancer

Sponsor

Fudan University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04394598

Collaborator

(none)

210

Enrollment

Location

Arms

Anticipated Duration (Months)

6.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 .

Condition or Disease	Intervention/Treatment	Phase
Locally Advanced Rectal Cancer	Drug: Dendrobium Huoshanense Granules Radiation: Pelvic Radiation Drug: Capecitabine Drug: Irinotecan Other: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

210 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Mar 1, 2020

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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 (UGT1A128 6/6) or 65mg/m2 (UGT1A128 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.	Drug: Dendrobium Huoshanense Granules 3g tid per day for 5weeks Radiation: Pelvic Radiation 50Gy/25Fx Drug: Capecitabine 625mg/m2 bid Monday-Friday per week Drug: Irinotecan 80mg/m2 (UGT1A128 6/6) or 65mg/m2 (UGT1A128 6/7)
Placebo Comparator: 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 (UGT1A128 6/6) or 65mg/m2 (UGT1A128 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.	Radiation: Pelvic Radiation 50Gy/25Fx Drug: Capecitabine 625mg/m2 bid Monday-Friday per week Drug: Irinotecan 80mg/m2 (UGT1A128 6/6) or 65mg/m2 (UGT1A128 6/7) Other: Placebo 3g tid per day for 5weeks

Arm

Intervention/Treatment

Experimental: 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.

Drug: Dendrobium Huoshanense Granules

3g tid per day for 5weeks

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)

Placebo Comparator: 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.

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)

Other: Placebo

3g tid per day for 5weeks

Outcome Measures

Primary Outcome Measures

the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0 [twice weekly during the neoadjuvant chemotherapy (5 weeks)]

Secondary Outcome Measures

Impact of participants' quality of life during treatment as assessed by EQ-5D questionnaire [once weekly during the neoadjuvant chemotherapy (5 weeks)]
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]
Number of the concurrent chemotherapy cycles that patients can receive during radiotherapy [once weekly during neoadjuvant chemoradiation(5 weeks,each cycle is one week)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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