A Study of Chinese Herbal Compound Dendrobium Huoshanense Granules in NCRT for Patients With Locally Advanced Rectal Cancer
NCT ID: NCT04394598
Last Updated: 2020-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
210 participants
INTERVENTIONAL
2020-03-01
2022-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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CRT with Dendrobium Huoshanense
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.
Dendrobium Huoshanense Granules
3g tid per day for 5weeks
Pelvic 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)
CRT with Placebo
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.
Pelvic 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)
Placebo
3g tid per day for 5weeks
Interventions
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Dendrobium Huoshanense Granules
3g tid per day for 5weeks
Pelvic 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)
Placebo
3g tid per day for 5weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Zhu Ji
Clinical Professor
Principal Investigators
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Zhen Zhang, MD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Zhen Zhang, MD
Role: CONTACT
Facility Contacts
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Zhen Zhang, MD
Role: backup
Other Identifiers
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FDRT-R20
Identifier Type: -
Identifier Source: org_study_id
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