Dendrobium Huoshanense Suppository in Rectal Cancer

Locally Advanced Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05079438
• Other study ID #: CARTOnG-2103
• Status: Recruiting
• Phase: Phase 3
• Start date: September 7, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: October 2021
• Source: Zhejiang Cancer Hospital
• Contact: Ji Zhu, MD
• Phone: 571-88128142
• Email: leo.zhu[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: August 31, 2024
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. pathological confirmed rectum adenocarcinoma

2. clinical stage T3-4 and/or N+

3. the distance from anal verge less than 10 cm

4. without distance metastases

5. performance status score: 0~1

6. without previous anti-cancer therapy

7. able to follow the protocol during the study period

8. sign the inform consen

Exclusion Criteria:

1. Pregnant or breastfeeding women

2. Those with other history of malignant disease in the past 5 years, except for cured skin cancer and cervical carcinoma in situ

3. 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.

4. 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

5. Organ transplantation requires immunosuppressive therapy Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases

6. 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

7. Anyone who is allergic to any research medication

8. DPD deficiency

Related Conditions & MeSH terms

• Locally Advanced Rectal Cancer
• Rectal Neoplasms

Intervention

Drug:
• Dendrobium Huoshanense Suppository
1.7g rectal administration per day for 5 weeks

Locations

Country	Name	City	State
China	Ji Zhu	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	=Grade 2 proctitis		During chemoradiotherapy