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

Primary Purpose

Locally Advanced Rectal Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Dendrobium Huoshanense Granules

Pelvic Radiation

Capecitabine

Irinotecan

Placebo

About this trial

This is an interventional prevention trial for Locally Advanced Rectal Cancer focused on measuring Neoadjuvant Chemoradiotherapy, Dendrobium Huoshanense, irinotecan, capecitabine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CRT with Dendrobium Huoshanense

CRT with Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0

Secondary Outcome Measures

Impact of participants' quality of life during treatment as assessed by EQ-5D questionnaire

Impact of participants' quality of life during treatment as assessed by EORTC-QLQ-C30 questionnaire

ORR(objective response rate) includes CR(complete rate) and PR(partial rate)

Number of the concurrent chemotherapy cycles that patients can receive during radiotherapy

Full Information

NCT ID

NCT04394598

First Posted

May 13, 2020

Last Updated

May 16, 2020

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT04394598

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Unknown status

Study Start Date

March 1, 2020 (Actual)

Primary Completion Date

June 1, 2022 (Anticipated)

Study Completion Date

December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Locally Advanced Rectal Cancer

Keywords

Neoadjuvant Chemoradiotherapy, Dendrobium Huoshanense, irinotecan, capecitabine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CRT with Dendrobium Huoshanense

Arm Type

Experimental

Arm Description

Arm Title

CRT with Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Dendrobium Huoshanense Granules

Intervention Description

3g tid per day for 5weeks

Intervention Type

Radiation

Intervention Name(s)

Pelvic Radiation

Intervention Description

50Gy/25Fx

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Intervention Description

625mg/m2 bid Monday-Friday per week

Intervention Type

Drug

Intervention Name(s)

Irinotecan

Intervention Description

80mg/m2 (UGT1A1*28 6/6) or 65mg/m2 (UGT1A1*28 6/7)

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

3g tid per day for 5weeks

Primary Outcome Measure Information:

Title

the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0

Time Frame

twice weekly during the neoadjuvant chemotherapy (5 weeks)

Secondary Outcome Measure Information:

Title

Impact of participants' quality of life during treatment as assessed by EQ-5D questionnaire

Time Frame

once weekly during the neoadjuvant chemotherapy (5 weeks)

Title

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)

Title

ORR(objective response rate) includes CR(complete rate) and PR(partial rate)

Time Frame

Surgery scheduled 6-8 weeks after the end of chemoradiation

Title

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ji Zhu, MD

Phone

+86-2164175590

Ext

81607

leo.zhu@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Zhen Zhang, MD

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhen Zhang, MD

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fudan University Shanghai Cancer Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200023

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhu Ji, MD

leo.zhu@126.com

First Name & Middle Initial & Last Name & Degree

Zhen Zhang, MD

12. IPD Sharing Statement

Learn more about this trial

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

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