Safety Study of Capecitabine With Radiation in Elderly Rectal Cancer

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase I study is designed to determine the maximum tolerant dose of capecitabine when used in preoperative concurrent chemo-radiation for locally advanced rectal patients over 75 years old.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Treatments: Capecitabine

Criteria

Inclusion Criteria:

• rectal adenocarcinoma, clinical stage II/III(T3-4 or N+, AJCC 7th).

• KPS status no less than 70; Charlson comorbidity no more than 3.

• life expectancy more than 6 months.

• hemoglobin >= 100g/L, white blood cell >= 3.5*10E9/L, neutrophil >= 1.5*10E9/L, platelet >= 100*10E9/L.Creatin normal, Total bilirubin normal, AST and AST normal, AKP normal.

• do not have allergy history to thymidine phosphorylase.

• do not receive surgery ( except palliative colostomy) or chemotherapy or other anti-cancer treatment

• no previously pelvic irradiation history

• informed consent signed

Exclusion Criteria:

• other cancer history, except curable non-melanoma skin cancer or cervix in-situ carcinoma

• previous pelvic irradiation history

• receiving surgery (except palliative colostomy), chemotherapy or other anti-cancer treatment

• allergy history to thymidine phosphorylase

• active infection existed

• severe complication, such as acute myocardial infarction in 6 months, uncontrolled diabetes ( Plasma glucose concentrations in any time of a day≥11.1mmol/L）, severe cardiac arrhythmia， etc.

• anticipate other clinical trials in four weeks before enrollment