Dendrobium Huoshanense Suppository in Rectal Cancer

NCT05079438 | Unknown Phase 3

• 1 other identifier: CARTOnG-2103
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced Rectal Cancer

Keywords

Neoadjuvant Chemoradiotherapy; Dendrobium Huoshanense; irinotecan; capecitabine

Outcome Measures

Primary Outcomes (1)

• ≥Grade 2 proctitis

  During chemoradiotherapy

Study Arms (2)

CRT with Dendrobium huoshanense Suppository

EXPERIMENTAL

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

CRT with Placebo

NO INTERVENTION

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）.

Interventions

Dendrobium Huoshanense Suppository DRUG

1.7g rectal administration per day for 5 weeks

CRT with Dendrobium huoshanense Suppository

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Ji Zhu

Hangzhou, Zhejiang, 310022, China

RECRUITING

Central Study Contacts

Ji Zhu, MD

CONTACT

571-88128142; leo.zhu@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 15, 2021
• Study Start: September 7, 2021
• Primary Completion: July 30, 2023
• Study Completion: August 31, 2024
• Last Updated: October 15, 2021

Record last verified: 2021-10

Locations

CN (1)