Overview

This trial is active, not recruiting.

Condition locally advanced undifferentiated carcinoma nasopharyngeal type ucnt
Treatment hydroxyurea
Phase phase 3
Sponsor Gustave Roussy, Cancer Campus, Grand Paris
Start date February 1995
Trial size 520 participants
Trial identifier NCT00180973, CSET 94/346, VUMCA2

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
5 year overall survival rate
time frame:

Secondary Outcomes

Measure
Time to progresion and local control at 2 years
time frame:

Eligibility Criteria

Male or female participants from 15 years up to 70 years old.

Inclusion Criteria: - of either sex - aged *15 and * 70 years - never previously treated with radiotherapy, chemotherapy or surgery for malignant disease (except neck adenectomy/diagnosis) - with aWHO performance status * 2. - amenable to regular follow-up - capable of receiving chemotherapy and radiotherapy : in particular, with no contraindications to the use of anthracyclines, bleomycin or cisplatinum. - with informed consent at entry time, in writing or witnessed oral informed consent, in accordance with local legislation requirements. - Laboratory requirement : *Baseline hematologic status : Neutrophil count * 2000 /mm3 Platelet count * 150,000 /mm3 Hemoglobin * 10 g / dl Exclusion Criteria: - Histologic types other than type II - III of the WHO classification - T1 - T2 N0 - N1 or patients with metastatic - Aged < 15 or > 70. - Patients in whom chemotherapy is contraindicated: history of myocardial infarction over the last 6 months before inclusion, or clinically present cardiac pathology. - WHO Performance status >2 - History of prior malignancies (other than non melanoma skin cancer or excised cervical carcinoma in situ). - Uncontrolled infection, - Patients refusing participation. - Patients who, for social, familial or geographic reasons are unlikely to comply with a long term follow-up.

Additional Information

Official title MULTICENTRIC INTERNATIONAL RANDOMIZED PHASE III TRIAL COMPARING, NEOADJUVANT CHEMOTHERAPY FOLLOWED BY STANDARD RADIOTHERAPY VERSUS THE SAME NEOADJUVANT CHEMOTHERAPY FOLLOWED BY STANDARD RADIOTHERAPY ASSOCIATED WITH DAILY HYDROXYUREA IN THE TREATMENT OF LOCALLY ADVANCED UNDIFFERENTIATED CARCINOMA NASOPHARYNGEAL TYPE.
Principal investigator François ESCHWEGE, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2005.
Information provided to ClinicalTrials.gov by Gustave Roussy, Cancer Campus, Grand Paris.