S-1, Cisplatin, and Radiation Therapy in Treating Patients With Stage IIA, Stage III, or Stage IV… (NCT00659113) | Clinical Trial Compass
UnknownPhase 2
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
South Korea32 participantsStarted 2008-03
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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, investigati…