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

Phase 1

• Conditions: Rectal Cancer
• Interventions: Drug: Chemoradiotherapy

• Registration Number: NCT02277158
• Lead Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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 To evaluate safety, data on adverse events will be collected from the time of enrollment until withdrawn of complete whole study.

Study Timeline

• Study First Submitted: 2014-10-22
• Study First Submitted QC: 2014-10-26
• Study First Posted: 2014-10-28
• Status Verified: 2014-11
• Study Start: 2014-11
• Last Update Submitted: 2014-11-30
• Last Update Posted: 2014-12-02
• Primary Completion: 2015-06
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chemoradiotherapy	Chemoradiotherapy	There are four dose levels and one arm only. Level 1: S-1, 50 mg/m2, Day 1-14, 22-35; RT Total dose 50.4Gy/28fractions/6 weeks Level 2: S-1, 65 mg/m2, Day 1-14, 22-35; RT Total dose 50.4Gy/28fractions/6 weeks Level 3: S-1, 80 mg/m2, Day 1-14, 22-35; RT Total dose 50.4Gy/28fractions/6 weeks Level 4: S-1, 90 mg/m2, Day 1-14, 22-35; RT Total dose 50.4Gy/28fractions/6 weeks

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD)	6weeks (42 days)

Secondary Outcome Measures

Name	Time	Method
Dose Limiting Toxicities (DLTs)	6weeks (42 days)
Quality of Life	6weeks (42 days)

Trial Locations

Locations (1)

Zhenzhou-Yang; 🇨🇳 Chongqing, Chongqing, China