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
|ClinicalTrials.gov Identifier: NCT00659113|
Recruitment Status : Unknown
Verified December 2008 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : April 16, 2008
Last Update Posted : December 6, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer||Drug: cisplatin Drug: tegafur-gimeracil-oteracil potassium Other: cytology specimen collection procedure Procedure: endoscopic biopsy||Phase 2|
- To evaluate response rate in patients with stage IIA-IVA resectable esophageal cancer treated with chemoradiotherapy comprising S-1, cisplatin, and radiotherapy.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of a TS-1/Cisplatin Based Definitive Chemoradiotherapy for Resectable Esophageal Cancer|
|Study Start Date :||March 2008|
- Response rate
- Overall survival
- Progression-free survival
- Initial squamous cell carcinoma antigen and C-reactive protein correlation with response and survival
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00659113
|Korea, Republic of|
|Yonsei Cancer Center at Yonsei University Medical Center||Recruiting|
|Seoul, Korea, Republic of, 120-752|
|Contact: Joo-Hang Kim, MD 82-2-2228-8131 firstname.lastname@example.org|
|Study Chair:||Joo-Hang Kim, MD||Yonsei University|