A Multicenter Phase II Trial of Docetaxel Combined With Cisplatin (CDDP) as a Neo-Adjuvant Chemotherapy in Patients With Loco Regionally Advanced Undifferentiated Carcinoma of Nasopharyngeal Type (UCNT)
Sponsor study identifier
interventional
66
3 countries
3
Study Start
July 2002
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2005
Actual (reported)Study Completion
November 2005
Actual (reported)Primary Objective: To estimate the overall response rate after neo-adjuvant chemotherapy of Docetaxel 75 mg/m2 in combination with Cisplatin 75 mg/m2 given for 3 cycles, and followed by conventional radiotherapy in UCNT. Secondary Objectives: To evaluate:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2005
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2002
Date type not reportedThis date has not been verified as actual or estimated.
November 2005
Actual (reported)November 2005
Actual (reported)June 5, 2009
Actual (reported)June 9, 2009
Actual (reported)Evaluation of tumor response in patients with measurable disease according to RECIST criteria
on day 21 of each treatment cycle for neoadjuvant chemotherapy, on day 64 and day 71 (3 to 4 weeks after the third chemotherapy)
Evaluation of the radiological response after chemotherapy and radiotherapy
from baseline to the end of the study
Evaluation of the pathological response after chemotherapy
between day 64 and day 71 of the treatment
Overall response duration
from baseline to the end of the study
Estimation of the time to progression
from baseline to the end of the study
Overall survival
from baseline to the end of the study
docetaxel 75mg/m2 in combination with cisplatin 75mg/m2 given every 3 weeks for 3 cycles
docetaxel 75mg/m2 by intravenous infusion over 60 minutes on Day 1 of a 3-week cycle
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Sanofi-Aventis Administrative Office
Algiers, Algeria
Sanofi-Aventis Administrative Office
Casablanca, Morocco
Sanofi-Aventis Administrative Office
Mégrine, Tunisia
Christian Fassotte
Sanofi
66 participants (actual enrollment reported by the registry).
First Submitted
June 5, 2009
First Posted
June 9, 2009
Study Start
July 2002
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
November 2005
Actual (reported)Study Completion
November 2005
Actual (reported)Last Updated
June 24, 2009
Record last verified: 2009-06
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Source: ClinicalTrials.gov.
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