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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

520 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-02-28

Brief Summary

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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).

Detailed Description

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Conditions

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LOCALLY ADVANCED UNDIFFERENTIATED CARCINOMA NASOPHARYNGEAL TYPE UCNT

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Hydroxyurea

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

15 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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François ESCHWEGE, MD

Role: PRINCIPAL_INVESTIGATOR

Gustave Roussy, Cancer Campus, Grand Paris

Locations

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Institut Gustave Roussy

Villejuif, , France

Site Status

Countries

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France

Other Identifiers

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CSET 94/346

Identifier Type: -

Identifier Source: secondary_id

VUMCA2