Study of Postoperative Concurrent Chemo-radiation With Capecitabine in Elderly Rectal Cancer Patients

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

Summary

The purpose of this study is to seek the proper dose of capecitabine in post-operative concurrent chemotherapy for stage II/III elderly rectal cancer patients receiving radical surgery, and evaluate the toleration of this modality in such patients.

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

Details

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

Criteria

Inclusion Criteria:

• rectal adenocarcinoma, pathological stage II/III(T3-4 or N+, UICC 2002), radical surgery received.

• interval between surgery and enrollment no less than two week and no more than 3 months.

• KPS status no less than 70; life expectancy no less than 6 months.

• without life-threatening complications, such as severe hypertension, coronary heart disease, cerebral vascular disease, uncontrolled diabetes, etc.

• without severe drug allergy history.

• hemoglobin >= 100g/L, white blood cell >= 3.5*10E9/L, neutrophil >= 1.5*10E9/L, platelet >= 100*10E9/L.

• Creatin <= 1.5* ULN(upper limit of normal), Total bilirubin <= 2.5 ULN, AST and AST <= 2.5* ULN, AKP <= 2.5*ULN

• do not receive chemotherapy before six months from enrollment.

• no previously pelvic irradiation history

• informed consent signed

Exclusion Criteria:

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

• allergy history to thymidine phosphorylase

• previous pelvic irradiation history

• receiving adjuvant chemotherapy in six months before enrollment

• 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.

• life expectancy less than 6 months

• estimated cannot finish treatment

• attend other clinical trials in four weeks before enrollment

• receive other anti-cancer treatment currently

• other conditions which regarded illegal by censors with full reasons. for example, some conditions may conflict from the protocol.