Rectal Cancer
Conditions
Keywords
Rectal cancer, S-1, Chemoradiotherapy, Phase I
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 To evaluate safety, data on adverse events will be collected from the time of enrollment until withdrawn of complete whole study.
Interventions
DRUGChemoradiotherapy
S-1 CCRT
Sponsors
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Tolerated Dose (MTD) | 6weeks (42 days) |
Secondary
| Measure | Time frame |
|---|---|
| Dose Limiting Toxicities (DLTs) | 6weeks (42 days) |
| Quality of Life | 6weeks (42 days) |
Countries
China
Contacts
Primary ContactZhenzhou Yang, MD, PhD
Outcome results
None listed