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.

Gustave Roussy

Status and phase

Unknown

Phase 3

Conditions

LOCALLY ADVANCED UNDIFFERENTIATED CARCINOMA NASOPHARYNGEAL TYPE UCNT

Treatments

Drug: Hydroxyurea

Study type

Interventional

Funder types

Other

Identifiers

NCT00180973

VUMCA2

CSET 94/346

Details and patient eligibility

About

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).

Sex

All

Ages

15 to 70 years old

Volunteers

No Healthy Volunteers

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.