Locally Advanced Rectal Cancer
Conditions
Keywords
Neoadjuvant Chemoradiotherapy, Dendrobium Huoshanense, irinotecan, capecitabine
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 .
Interventions
DRUGIrinotecan
80mg/m2 (UGT1A1\*28 6/6) or 65mg/m2 (UGT1A1\*28 6/7)
OTHERPlacebo
3g tid per day for 5weeks
DRUGDendrobium Huoshanense Granules
3g tid per day for 5weeks
RADIATIONPelvic Radiation
50Gy/25Fx
DRUGCapecitabine
625mg/m2 bid Monday-Friday per week
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0 | twice weekly during the neoadjuvant chemotherapy (5 weeks) |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
Countries
China
Contacts
Primary ContactJi Zhu, MD
Backup ContactZhen Zhang, MD
Outcome results
None listed