Trial of Docetaxel, Cisplatin, Fluorouracil (5-FU) for Unresectable Advanced Esophageal Squamous Cell Carcinoma (ESCC)
|ClinicalTrials.gov Identifier: NCT00915850|
Recruitment Status : Unknown
Verified September 2010 by Wakayama Medical University.
Recruitment status was: Recruiting
First Posted : June 8, 2009
Last Update Posted : September 9, 2010
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer||Drug: DCF||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Trial of Combination Chemotherapy With Docetaxel, Cisplatin and 5-FU for Unresectable Advanced Esophageal Cancer.|
|Study Start Date :||August 2007|
|Estimated Primary Completion Date :||August 2010|
|Estimated Study Completion Date :||August 2015|
Experimental: Anticancer drug
docetaxel, cisplatin and 5-FU
docetaxel, Cisplatin and 5-FU
Other Name: docetaxel+Cisplatin+5-FU
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00915850
|Contact: Makoto Iwahashi, MDemail@example.com|
|Wakayama Medical University||Recruiting|
|Wakayama, Japan, 641-8510|
|Contact: Makoto Iwahashi, MD 81-73-441-0613 firstname.lastname@example.org|
|Study Director:||Makoto Iwahashi, M.D.||Second Department of Surgery, Wakayama Medical University|