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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00180973
Other study ID # VUMCA2
Secondary ID CSET 94/346
Status Active, not recruiting
Phase Phase 3
First received September 13, 2005
Last updated September 13, 2005
Start date February 1995

Study information

Verified date September 2005
Source Gustave Roussy, Cancer Campus, Grand Paris
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

MULTICENTRIC INTERNATIONAL RANDOMIZED PHASE III TRIAL COMPARING, NEOADJUVANT CHEMOTHERAPY (BEC REGIMEN) FOLLOWED BY STANDARD RADIOTHERAPY (70 Gy / 7 WEEKS) VERSUS THE SAME NEOADJUVANT CHEMOTHERAPY FOLLOWED BY STANDARD RADIOTHERAPY ASSOCIATED WITH DAILY HYDROXYUREA IN THE TREATMENT OF LOCALLY ADVANCED UNDIFFERENTIATED CARCINOMA NASOPHARYNGEAL TYPE (UCNT).


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Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Hydroxyurea


Locations

Country Name City State
France Institut Gustave Roussy Villejuif

Sponsors (1)

Lead Sponsor Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 5 year overall survival rate
Secondary Time to progresion and local control at 2 years