Clinical trial · Interventional
S-1, Cisplatin, and Radiation Therapy in Treating Patients With Stage IIA, Stage III, or Stage IVA Esophageal Cancer That Can Be Removed by Surgery
A Phase II Trial of a TS-1/Cisplatin Based Definitive Chemoradiotherapy for Resectable Esophageal Cancer
- 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)
RATIONALE: Drugs used in chemotherapy, such as S-1 and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy together with more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving S-1 and cisplatin together with radiation therapy works in treating patients with stage IIA, stage III, or stage IVA esophageal cancer that can be removed by surgery.
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 |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| cytology specimen collection procedure | Other | — | UNRESOLVED |
| endoscopic biopsy | Procedure | — | UNRESOLVED |
| tegafur-gimeracil-oteracil potassium | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response rate
Secondary outcomes (4)
- measure
- Overall survival
- measure
- Progression-free survival
- measure
- Toxicity
- measure
- Initial squamous cell carcinoma antigen and C-reactive protein correlation with response and survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed carcinoma of the esophagus * Stage IIA-IVA disease * Resectable disease * Measurable disease, defined as at least 1 measurable lesion by RECIST criteria * No known brain metastasis PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy \> 3 months * ANC ≥ 1,500/uL * Hemoglobin ≥ 9.0 g/dL (transfusion correction allowed) * Platelets ≥ 100,000/uL * Creatinine \< 1.5 mg/dL * Total bilirubin \< 2 times upper limit of normal (ULN) * ALT/AST \< 3 times ULN * Fertile patients must use effective contraception * Not pregnant or nursing * Able to take oral medication * No active peptic ulcer disease * No known hypersensitivity to study drugs * No serious uncontrolled systemic intercurrent illness, including the following: * Poorly controlled diabetes * Active infection * No history of significant neurological or mental disorder, including seizures or dementia * No malignancy within the past 5 years, except carcinoma in situ of the cervix, or nonmelanomatous carcinoma of the skin * No active cardiac disease uncontrolled by therapy * No myocardial infarction within the past 12 months * No interstitial lung disease or extended fibrosis of lung PRIOR CONCURRENT THERAPY: * No prior chemotherapy or radiotherapy for esophageal cancer * No prior surgical procedure affecting absorption * No concurrent flucytosine or other fluoropyrimidine-group anticancer drugs * No concurrent systemic chemotherapy, investigational drug, or radiotherapy
References
Publications (0)
Data not yet available