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.

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00180973

Enrollment

520

Registered

2005-09-16

Start date

1995-02-28

Completion date

Unknown

Last updated

2005-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

LOCALLY ADVANCED UNDIFFERENTIATED CARCINOMA NASOPHARYNGEAL TYPE UCNT

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 FOLLOWED BY STANDARD RADIOTHERAPY ASSOCIATED WITH DAILY HYDROXYUREA IN THE TREATMENT OF LOCALLY ADVANCED UNDIFFERENTIATED CARCINOMA NASOPHARYNGEAL TYPE (UCNT).

Interventions

DRUGHydroxyurea

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame
5 year overall survival rate	—

Secondary

Measure	Time frame
Time to progresion and local control at 2 years	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026