Clinical trial · Interventional
Phase I Study of CCRT as Adjuvant Treatment for Stage II/III Operable Rectal Cancer.
A Phase I Study of Concurrent Radiotherapy and Tegafur, Gimeracil and Oteracil Potassium Capsule(S-1) as Adjuvant Treatment for Stage II/III Operable Rectal Cancer.
NCT02277158CI-TRIAL-00016189unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the maximum tolerated dose and safety of S-1 plus radiotherapy for patients with rectal cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemoradiotherapy | Drug | Chemoradiotherapy | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemoradiotherapy
- 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
- interventionNames
- Drug: Chemoradiotherapy
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD)
- timeFrame
- 6weeks (42 days)
Secondary outcomes (2)
- measure
- Dose Limiting Toxicities (DLTs)
- timeFrame
- 6weeks (42 days)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.