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

Army Medical University of People's Liberation Army

Status and phase: Unknown; Phase 1

Conditions: Rectal Cancer

Treatments: Drug: Chemoradiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02277158

DP03182014

Details and patient eligibility

About

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

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 To evaluate safety, data on adverse events will be collected from the time of enrollment until withdrawn of complete whole study.

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Chemoradiotherapy

Experimental group

Description:

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

Treatment:

Drug: Chemoradiotherapy