Clinical trial NCT04394598: A Study of Chinese Herbal Compound Dendrobium Huoshanense Granules in NCRT for Patients With Locally Advanced Rectal Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Locally Advanced Rectal Cancer
Keywords: Neoadjuvant Chemoradiotherapy
Dendrobium Huoshanense
irinotecan
capecitabine
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 .


Eligibility criteria: 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

Primary outcomes:
measure: the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0
timeFrame: twice weekly during the neoadjuvant chemotherapy (5 weeks)
Secondary outcomes:
measure: Impact of participants' quality of life during treatment as assessed by EQ-5D questionnaire
timeFrame: once weekly during the neoadjuvant chemotherapy (5 weeks)
measure: Impact of participants' quality of life during treatment as assessed by EORTC-QLQ-C30 questionnaire
timeFrame: once weekly during the neoadjuvant chemotherapy (5 weeks)
measure: ORR(objective response rate) includes CR(complete rate) and PR(partial rate)
timeFrame: Surgery scheduled 6-8 weeks after the end of chemoradiation
measure: Number of the concurrent chemotherapy cycles that patients can receive during radiotherapy
timeFrame: once weekly during neoadjuvant chemoradiation(5 weeks,each cycle is one week)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Zhen Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: