Esophageal Cancer Clinical Trial
Official title:
A Phase II Trial of a TS-1/Cisplatin Based Definitive Chemoradiotherapy for Resectable Esophageal Cancer
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.
OBJECTIVES:
Primary
- To evaluate response rate in patients with stage IIA-IVA resectable esophageal cancer
treated with chemoradiotherapy comprising S-1, cisplatin, and radiotherapy.
Secondary
- To evaluate overall survival of these patients.
- To evaluate progression-free survival of these patients.
- To evaluate toxicity in these patients.
- To correlate initial squamous cell carcinoma antigen and C-reactive protein with
response and survival in these patients.
OUTLINE: Patients receive oral S-1 twice weekly, cisplatin IV over 2 hours on day 1, and
undergo radiotherapy 5 days a week in weeks 1 and 2. Treatment repeats every 3 weeks for 2
courses.
Tumor tissue samples are collected by esophagoscopy with biopsy and brushings for analysis
of initial squamous cell carcinoma antigen and C-reactive protein correlation with response
and survival.
After completion of study treatment, patients are followed for 6 months.
;
Masking: Open Label, Primary Purpose: Treatment
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