UMIN ID: UMIN000001439
Registered date:05/01/2009
A phase II trial of concurrent chemoradiotherapy with 5-FU plus cisplatin for resectable squamous cell carcinoma of cervical esophagus
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | cervical esophageal cancer |
| Date of first enrollment | 2008/11/01 |
| Target sample size | 32 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | 5-FU(700mg/m2 d1-4)+ CDDP(70mg/m2 d1) q4w+RT(60Gy) 5-FU(800mg/m2 d1-5)+ CDDP(80mg/m2 d1) q4w |
Outcome(s)
| Primary Outcome | Overall survival |
|---|---|
| Secondary Outcome | Treatment compliance CR rate Progression free survival 3-year larynx preservation survival toxicity |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1.have lymph node metastases at neck level II area 2.have active concomitant malignancy 3.A Hbs antigen is positive 4.pregnant or may be pregnant |
Related Information
| Primary Sponsor | National Cancer Center Hospital |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Health, Labour and Welfare A grant-in-aid for cancer research plan study |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Sadamoto Zenda |
| Address | 6-5-1Kashiwanoha kashiwa chiba Japan |
| Telephone | 03-3411-1111 |
| szenda@east.ncc.go.jp | |
| Affiliation | National Cancer Center Hospital East Radiation Oncology Division |
| scientific contact | |
| Name | Masato Fujii |
| Address | 2-5-1Higashigaoka Meguro Tokyo 152-8902, Japan Japan |
| Telephone | 04-7133-1111 |
| szenda@east.ncc.go.jp | |
| Affiliation | National Tokyo Medical Center Dept. of Otolaryngology, |