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

NCT04394598 | Unknown Phase 2

• 1 other identifier: FDRT-R20
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Locally Advanced Rectal Cancer

Keywords

Neoadjuvant Chemoradiotherapy; Dendrobium Huoshanense; irinotecan; capecitabine

Outcome Measures

Primary Outcomes (1)

• the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0

  twice weekly during the neoadjuvant chemotherapy (5 weeks)

Secondary Outcomes (4)

• Impact of participants' quality of life during treatment as assessed by EQ-5D questionnaire

  once weekly during the neoadjuvant chemotherapy (5 weeks)

• Impact of participants' quality of life during treatment as assessed by EORTC-QLQ-C30 questionnaire

  once weekly during the neoadjuvant chemotherapy (5 weeks)

• ORR(objective response rate) includes CR(complete rate) and PR(partial rate)

  Surgery scheduled 6-8 weeks after the end of chemoradiation

• Number of the concurrent chemotherapy cycles that patients can receive during radiotherapy

  once weekly during neoadjuvant chemoradiation(5 weeks,each cycle is one week)

Study Arms (2)

CRT with Dendrobium Huoshanense

EXPERIMENTAL

Dendrobium Huoshanense Granules: 3g tid per day for 5weeks Concurrent Chemoradiotherapy: Radiation: 50Gy/25Fx; Capecitabine: 625mg/m2 bid Monday-Friday per week; Irinotecan: 80mg/m2 (UGT1A1\*28 6/6) or 65mg/m2 (UGT1A1\*28 6/7) Chemotherapy in Interval Between CRT and Surgery: Capecitabine: 1000mg/m2 bid d1-14; Irinotecan: 200mg/m2 d1 Surgery: Scheduled 6-8 weeks after the completion of CRT Adjuvant Chemotherapy: depends on patients pathological review.

Drug: Dendrobium Huoshanense Granules; Radiation: Pelvic Radiation; Drug: Capecitabine; Drug: Irinotecan

CRT with Placebo

PLACEBO COMPARATOR

Placebo: 3g tid per day for 5weeks Concurrent Chemoradiotherapy: Radiation: 50Gy/25Fx; Capecitabine: 625mg/m2 bid Monday-Friday per week; Irinotecan: 80mg/m2 (UGT1A1\*28 6/6) or 65mg/m2 (UGT1A1\*28 6/7) Chemotherapy in Interval Between CRT and Surgery: Capecitabine: 1000mg/m2 bid d1-14; Irinotecan: 200mg/m2 d1 Surgery: Scheduled 6-8 weeks after the completion of CRT Adjuvant Chemotherapy: depends on patients pathological review.

Radiation: Pelvic Radiation; Drug: Capecitabine; Drug: Irinotecan; Other: Placebo

Interventions

Dendrobium Huoshanense Granules DRUG

3g tid per day for 5weeks

CRT with Dendrobium Huoshanense

Pelvic Radiation RADIATION

50Gy/25Fx

CRT with Dendrobium Huoshanense; CRT with Placebo

Capecitabine DRUG

625mg/m2 bid Monday-Friday per week

CRT with Dendrobium Huoshanense; CRT with Placebo

Irinotecan DRUG

80mg/m2 (UGT1A1\*28 6/6) or 65mg/m2 (UGT1A1\*28 6/7)

CRT with Dendrobium Huoshanense; CRT with Placebo

Placebo OTHER

3g tid per day for 5weeks

CRT with Placebo

Eligibility Criteria

• Age: 18 Years - 70 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
• 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

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
• UGT1A1\*28 7/7

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200023, China

RECRUITING

MeSH Terms

Interventions

Capecitabine; Irinotecan

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Camptothecin; Alkaloids

Study Officials

• Zhen Zhang, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ji Zhu, MD

CONTACT

+86-2164175590; leo.zhu@126.com

Zhen Zhang, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 19, 2020
• Study Start: March 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 19, 2020

Record last verified: 2020-05

Locations

CN (1)