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Dendrobium Huoshanense Suppository in Rectal Cancer

Primary Purpose

Locally Advanced Rectal Cancer

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Dendrobium Huoshanense Suppository

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 - 75 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
without previous anti-cancer therapy
able to follow the protocol during the study period
sign the inform consen

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

Sites / Locations

Ji ZhuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CRT with Dendrobium huoshanense Suppository

CRT with Placebo

Arm Description

Dendrobium huoshanense Suppository: 1.7g rectal administration per day for 5 weeks Concurrent Chemoradiotherapy: Radiation: 50Gy/25Fx; Capecitabine: 625mg/m2 bid Monday-Friday per week; Irinotecan: 80mg/m2 (UGT1A1*28 and *6: 6/6+GG) or 65mg/m2 (UGT1A1*28 and *6 ：6/7+GG or 6/6+GA) or 50mg/m2 （UGT1A1*28 and *6 ：7/7+GG or 6/6+AA or 6/7+GA）.

Placebo: 1.7g rectal administration per day for 5 weeks Concurrent Chemoradiotherapy: Radiation: 50Gy/25Fx; Capecitabine: 625mg/m2 bid Monday-Friday per week; Irinotecan: 80mg/m2 (UGT1A1*28 and *6: 6/6+GG) or 65mg/m2 (UGT1A1*28 and *6 ：6/7+GG or 6/6+GA) or 50mg/m2 （UGT1A1*28 and *6 ：7/7+GG or 6/6+AA or 6/7+GA）.

Outcomes

Primary Outcome Measures

≥Grade 2 proctitis

Secondary Outcome Measures

Full Information

NCT ID

NCT05079438

First Posted

October 1, 2021

Last Updated

October 1, 2021

Sponsor

Zhejiang Cancer Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05079438

Brief Title

Dendrobium Huoshanense Suppository in Rectal Cancer

Official Title

A Multicenter Randomized Controlled Stage III Clinical Study of Dendrobium Huoshanense Suppository in Locally Advanced Rectal Cancer Patients Treated by Neoadjuvant Chemoradiotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Recruiting

Study Start Date

September 7, 2021 (Actual)

Primary Completion Date

July 30, 2023 (Anticipated)

Study Completion Date

August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zhejiang Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

To evaluates the role of Dendrobium Huoshanense Suppository for radiation proctitis in locally advanced rectal cancer treated by capecitabine and irinotecan based neoadjuvant chemoradiation.

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 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CRT with Dendrobium huoshanense Suppository

Arm Type

Experimental

Arm Description

Arm Title

CRT with Placebo

Arm Type

No Intervention

Arm Description

Intervention Type

Drug

Intervention Name(s)

Dendrobium Huoshanense Suppository

Intervention Description

1.7g rectal administration per day for 5 weeks

Primary Outcome Measure Information:

Title

≥Grade 2 proctitis

Time Frame

During chemoradiotherapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 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 without previous anti-cancer therapy able to follow the protocol during the study period sign the inform consen 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

Central Contact Person:

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

Ji Zhu, MD

Phone

571-88128142

Ext

+86

leo.zhu@126.com

Facility Information:

Facility Name

Ji Zhu

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310022

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

JI Zhu, MD

Phone

571-88128142

Ext

+86

leo.zhu@126.com

12. IPD Sharing Statement

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Dendrobium Huoshanense Suppository in Rectal Cancer

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