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

Locally Advanced Rectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04394598
• Other study ID #: FDRT-R20
• Status: Recruiting
• Phase: Phase 2
• Start date: March 1, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: May 2020
• Source: Fudan University
• Contact: Ji Zhu, MD
• Phone: +86-2164175590
• Email: leo.zhu[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: December 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Locally Advanced Rectal Cancer
• Rectal Neoplasms

Intervention

Drug:
• Dendrobium Huoshanense Granules
3g tid per day for 5weeks

Radiation:
• Pelvic Radiation
50Gy/25Fx

Drug:
• Capecitabine
625mg/m2 bid Monday-Friday per week
• Irinotecan
80mg/m2 (UGT1A1*28 6/6) or 65mg/m2 (UGT1A1*28 6/7)

Other:
• Placebo
3g tid per day for 5weeks

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0		twice weekly during the neoadjuvant chemotherapy (5 weeks)
Secondary	Impact of participants' quality of life during treatment as assessed by EQ-5D questionnaire		once weekly during the neoadjuvant chemotherapy (5 weeks)
Secondary	Impact of participants' quality of life during treatment as assessed by EORTC-QLQ-C30 questionnaire		once weekly during the neoadjuvant chemotherapy (5 weeks)
Secondary	ORR(objective response rate) includes CR(complete rate) and PR(partial rate)		Surgery scheduled 6-8 weeks after the end of chemoradiation
Secondary	Number of the concurrent chemotherapy cycles that patients can receive during radiotherapy		once weekly during neoadjuvant chemoradiation(5 weeks,each cycle is one week)