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

May 16, 2020 updated by: Zhu Ji, Fudan University

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

210

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Zhen Zhang, MD

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200023
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
          • Zhen Zhang, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0
Time Frame: twice weekly during the neoadjuvant chemotherapy (5 weeks)
twice weekly during the neoadjuvant chemotherapy (5 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Impact of participants' quality of life during treatment as assessed by EQ-5D questionnaire
Time Frame: once weekly during the neoadjuvant chemotherapy (5 weeks)
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)
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
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)
once weekly during neoadjuvant chemoradiation(5 weeks,each cycle is one week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2020

Primary Completion (ANTICIPATED)

June 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

May 13, 2020

First Submitted That Met QC Criteria

May 16, 2020

First Posted (ACTUAL)

May 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 19, 2020

Last Update Submitted That Met QC Criteria

May 16, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDRT-R20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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