Status:
UNKNOWN
Phase I Study of CCRT as Adjuvant Treatment for Stage II/III Operable Rectal Cancer.
Lead Sponsor:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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
Detailed Description
This stage I study is designed to evaluate the appropriate dose of S-1 plus radiotherapy for patients with R0 resection of rectal cancer for stage II-III patients(AJCC 7th). To evaluate safety, data o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2015
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT02277158
Start Date
November 1 2014
End Date
December 1 2015
Last Update
December 2 2014
Active Locations (1)
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1
Zhenzhou-Yang
Chongqing, Chongqing Municipality, China