Phase I Study of CCRT as Adjuvant Treatment for Stage II/III Operable Rectal Cancer.

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the maximum tolerated dose and safety of S-1 plus radiotherapy for patients with rectal cancer

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

Details

• Lead Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Criteria

Inclusion Criteria:

• R0 resection of histologically proved stage II/III rectal cancer;

• 18-75 years old;

• No previous radiotherapy or chemotherapy for rectal cancer;

• Performance status of ECOG 0,1;

• Adequate organ function defined as below:

i. WBC ≥ 4,000/mm^3 ii. ANC ≥ 1,500/mm^3 iii. Hemoglobin ≥ 10g/dL iv. Platelet ≥ 100,000/m^3 v. Total bilirubin ≤ 1.5ULN vi. AST/ALT ≤ 1.5ULN vii. Serum creatinine ≤ 1.5ULN or creatinine clearance rate ≥ 60ml/min、Urea nitrogen ≤ 1.5ULN viii. Protein in urine dipstick test<1+; if the test result >1+ ,total protein in urea must <500mg within 24 hours

• Able to receive oral administration

• Informed consent

Exclusion Criteria:

• Hypersensitive to S-1 or its excipients

• Pulmonary fibrosis or interstitial pneumonitis found within 28 days prior to registration

• Significant co-morbid medical conditions, including, but not limited to, heart failure, renal failure, hepatic failure, hemorrhagic peptic ulcer, mechanical or paralytic ileus, or poorly controlled diabetes

• Received any investigational drug or anti-cancer agent

• Pregnant or lactating female or pregnancy test positive

• Severe mental disorder

• Judged ineligible by physicians for participation in the study due to safety concern.