Preoperative Chemoradiotherapy With Raltitrexed for Intermediate or Locally Advanced Rectal Cancer in the Fit Elderly

• Status: Completed
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this multicenter phase II study is to evaluate the response rate, local control, disease-free survival and treatment-related toxicity of preoperative chemoradiation for intermediate or locally advanced rectal cancer in the fit elderly.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

• Inclusion Criteria:

• Rectal adenocarcinoma, clinical stage II/III(T3-4 or N+, AJCC 7th), and fulfils the intermediate or locally advanced risk category standard of ESMO recal cancer clinical practice guidelines 2013.

• KPS status no less than 70; Charlson comorbidity no more than 2; Fit status evaluated by CGA.

• 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 receive surgery ( except palliative colostomy) or chemotherapy or other anti-cancer treatment.

• No previously pelvic irradiation history.

• Through MDT discussion, the patient is considered to be candidate for preoperative CRT followed by surgery.

• Informed consent signed.

• Exclusion Criteria:

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

• Allergy history to analog of quinazoline folate.

• 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.