A phase II trial of definitive chemoradiotherapy with docetaxel, cisplatin, and 5-fluorouracil (DCF-R) for advanced esophageal carcinoma (KDOG 0501 P2)

UMIN ID: UMIN000002029

Registered date:01/06/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: locally advanced esophageal carcinoma
• Date of first enrollment: 2005/03/01
• Target sample size: 35
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Patients receive an infusion of docetaxel (35 mg/m2) and an infusion of cisplatin (40 mg/m2) on days 1, 15, and 29 plus a continuous infusion of 5-fluorouracil (400 mg/m2/day) on days 1-5, 15-19, and 29-33. And patients receive 50.4 Gy/28 fractions of concurrent radiotherapy.

Outcome(s)

• Primary Outcome: complete response rate
• Secondary Outcome: Response rate Adverse events Progression free survival(PFS) Overall Survival(OS)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1. History of serious drug hypersensitivity 2. Active gastrointestinal bleeding 3. Active infection 4. Severe complication (interstitial pneumonia or pulmonary fibrosis, poorly controlled diabetes mellitus, heart failure, renal failure, liver cirrhosis or etc) 5. Active synchronous or metachronous malignancy other than carcinoma in situ. 6. Mental disorders being treated with antipsychotic agents or requiring treatment 7. Pregnant or lactation women, or women with the possibility of the pregnancy 8. Men who want let to pregnancy 9. Patients who are judged inappropriate for the entry into the study by the investigater

Related Information

• Primary Sponsor: Kitasato University School of Medicine
• Source(s) of Monetary Support: Kitasato University School of Medicine, Department of Gastroenterology