Trial of Docetaxel, Cisplatin, Fluorouracil (5-FU) for Unresectable Advanced Esophageal Squamous Cell Carcinoma (ESCC)
Recruitment status was: Recruiting
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Trial of Combination Chemotherapy With Docetaxel, Cisplatin and 5-FU for Unresectable Advanced Esophageal Cancer.|
- Safety (Phase I: toxicities as assessed by NCI CTCAE version3) and efficacy (Phase II: Feasibility as evaluated by RECIST) [ Time Frame: 1 month ]
- To determine the recommended phase II dose of docetaxel (Phase I) [ Time Frame: 1 month ]
- To determine the clinical effectiveness in the patients with measurable disease (Phase I) [ Time Frame: 1 month ]
- To analyze the toxicity (Phase II) [ Time Frame: 1 month ]
- Time to progression (Phase II) [ Time Frame: 5 years ]
- median survival time (Phase II) [ Time Frame: 5 years ]
|Study Start Date:||August 2007|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
Experimental: Anticancer drug
docetaxel, cisplatin and 5-FU
docetaxel, Cisplatin and 5-FU
Other Name: docetaxel+Cisplatin+5-FU
To establish the safety of combination chemotherapy comprising docetaxel (escalating doses: 25,30,35,40 mg/m2,day1 and day8), cisplatin (12mg/m2,day1-5), and fluorouracil (600mg/m2,day1-5) (DCF) in unresectable advanced esophageal cancer.
To observe the efficacy of this regimen in these patients.
To assess the response rate of combination chemotherapy comprising docetaxel (recommended dose determined in phase I study,day1 and day8), cisplatin (12 mg/m2, day1-5), and fluorouracil (600 mg/m2, day1-5) (DCF) in unresectable advanced esophageal cancer.
To determine the adverse reactions of this regimen in these patients. To determine TTP(Time to progression) of patients treated with this regimen. To determine MST(Median survival time) of patients treated with this regimen.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00915850
|Wakayama Medical University|
|Wakayama, Japan, 641-8510|
|Study Director:||Makoto Iwahashi, M.D.||Second Department of Surgery, Wakayama Medical University|