Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| LOCALLY ADVANCED UNDIFFERENTIATED CARCINOMA NASOPHARYNGEAL TYPE UCNT | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hydroxyurea | Drug | Hydroxyurea | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 5 year overall survival rate
Secondary outcomes (1)
- measure
- Time to progresion and local control at 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available