Locally Advanced Rectal Cancer
Conditions
Keywords
Neoadjuvant Chemoradiotherapy, Dendrobium Huoshanense, irinotecan, capecitabine
Brief summary
To evaluates the role of Dendrobium Huoshanense Suppository for radiation proctitis in locally advanced rectal cancer treated by capecitabine and irinotecan based neoadjuvant chemoradiation.
Interventions
DRUGDendrobium Huoshanense Suppository
1.7g rectal administration per day for 5 weeks
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. pathological confirmed rectum adenocarcinoma 2. clinical stage T3-4 and/or N+ 3. the distance from anal verge less than 10 cm 4. without distance metastases 5. performance status score: 0\ 1 6. without previous anti-cancer therapy 7. able to follow the protocol during the study period 8. sign the inform consen
Exclusion criteria
1. Pregnant or breastfeeding women 2. Those with other history of malignant disease in the past 5 years, except for cured skin cancer and cervical carcinoma in situ 3. 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. 4. 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 5. Organ transplantation requires immunosuppressive therapy Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases 6. 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 7. Anyone who is allergic to any research medication 8. DPD deficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ≥Grade 2 proctitis | During chemoradiotherapy |
Countries
China
Contacts
Primary ContactJi Zhu, MD
Outcome results
None listed