Status:
UNKNOWN
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.
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Conditions:
LOCALLY ADVANCED UNDIFFERENTIATED CARCINOMA NASOPHARYNGEAL TYPE UCNT
Eligibility:
All Genders
15-70 years
Phase:
PHASE3
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 FOL...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 1995
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
520 Patients enrolled
Trial Details
Trial ID
NCT00180973
Start Date
February 1 1995
Last Update
September 16 2005
Active Locations (1)
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1
Institut Gustave Roussy
Villejuif, France, 94800