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
- Conditions
- Esophageal Cancer
- Registration Number
- NCT00659113
- Lead Sponsor
- Yonsei University
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 32
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate
- Secondary Outcome Measures
Name Time Method Overall survival Progression-free survival Toxicity Initial squamous cell carcinoma antigen and C-reactive protein correlation with response and survival
Trial Locations
- Locations (1)
Yonsei Cancer Center at Yonsei University Medical Center
🇰🇷Seoul, Korea, Republic of