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.
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.
2 other identifiers
interventional
520
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 1995
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedSeptember 16, 2005
September 1, 2005
September 13, 2005
September 13, 2005
Conditions
Outcome Measures
Primary Outcomes (1)
5 year overall survival rate
Secondary Outcomes (1)
Time to progresion and local control at 2 years
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Histologic types other than type II - III of the WHO classification
- T1 - T2 N0 - N1 or patients with metastatic
- Aged \< 15 or \> 70.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institut Gustave Roussy
Villejuif, 94800, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
François ESCHWEGE, MD
Gustave Roussy, Cancer Campus, Grand Paris
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 16, 2005
Study Start
February 1, 1995
Last Updated
September 16, 2005
Record last verified: 2005-09