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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.


Phase 3
15 Years
70 Years
Open (Enrolling)
Both
LOCALLY ADVANCED UNDIFFERENTIATED CARCINOMA NASOPHARYNGEAL TYPE UCNT

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Trial Information

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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

5 year overall survival rate

Principal Investigator

François ESCHWEGE, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

VUMCA2

NCT ID:

NCT00180973

Start Date:

February 1995

Completion Date:

Related Keywords:

  • LOCALLY ADVANCED UNDIFFERENTIATED CARCINOMA NASOPHARYNGEAL TYPE UCNT
  • Carcinoma
  • Nasopharyngeal Neoplasms

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