Dendrobium Huoshanense Suppository in Rectal Cancer

Sponsor

Zhejiang Cancer Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05079438

Collaborator

(none)

168

Enrollment

Location

Arms

35.8

Anticipated Duration (Months)

4.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Locally Advanced Rectal Cancer	Drug: Dendrobium Huoshanense Suppository	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

168 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 7, 2021

Anticipated Primary Completion Date :

Jul 30, 2023

Anticipated Study Completion Date :

Aug 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CRT with Dendrobium huoshanense Suppository 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 (UGT1A128 and 6: 6/6+GG) or 65mg/m2 (UGT1A128 and 6 ：6/7+GG or 6/6+GA) or 50mg/m2 （UGT1A128 and 6 ：7/7+GG or 6/6+AA or 6/7+GA）.	Drug: Dendrobium Huoshanense Suppository 1.7g rectal administration per day for 5 weeks
No Intervention: CRT with Placebo 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 (UGT1A128 and 6: 6/6+GG) or 65mg/m2 (UGT1A128 and 6 ：6/7+GG or 6/6+GA) or 50mg/m2 （UGT1A128 and 6 ：7/7+GG or 6/6+AA or 6/7+GA）.

Arm

Intervention/Treatment

Experimental: CRT with Dendrobium huoshanense Suppository

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）.

Drug: Dendrobium Huoshanense Suppository

1.7g rectal administration per day for 5 weeks

No Intervention: CRT with Placebo

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）.

Outcome Measures

Primary Outcome Measures

≥Grade 2 proctitis [During chemoradiotherapy]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 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
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ji Zhu	Hangzhou	Zhejiang	China	310022

Sponsors and Collaborators

Zhejiang Cancer Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

zhuji, Professor, Zhejiang Cancer Hospital

ClinicalTrials.gov Identifier:

NCT05079438

Other Study ID Numbers:

CARTOnG-2103

First Posted:

Oct 15, 2021

Last Update Posted:

Oct 15, 2021

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by zhuji, Professor, Zhejiang Cancer Hospital

Neoadjuvant Chemoradiotherapy

Dendrobium Huoshanense

irinotecan

capecitabine

Additional relevant MeSH terms:

Rectal Neoplasms

Study Results

No Results Posted as of Oct 15, 2021