LOCALLY ADVANCED UNDIFFERENTIATED CARCINOMA NASOPHARYNGEAL TYPE UCNT Clinical Trial
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.
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).
| Status | Active, not recruiting |
| Enrollment | 520 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 15 Years to 70 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Institut Gustave Roussy | Villejuif |
| Lead Sponsor | Collaborator |
|---|---|
| Gustave Roussy, Cancer Campus, Grand Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 5 year overall survival rate | |||
| Secondary | Time to progresion and local control at 2 years |