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
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|