PHASE III TRIAL COMPARING, NEOADJUVANT CHEMOTHERAPY FOLLO... | NCT00180973

Studies
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.

NCT00180973

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Status

Unknown status

Last Update Posted

Sep 16, 2005Estimated

Enrollment

520

Phase

Phase 3

Conditions

LOCALLY ADVANCED UNDIFFERENTIATED CARCINOMA NASOPHARYNGEAL TYPE UCNT

Interventions

Hydroxyurea

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
CSET 94/346

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1995

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2005

Last Update Posted Date

Sep 16, 2005Estimated

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

520

Name	Type	Description	Arm Group Labels	Other Names
Hydroxyurea	Drug

Measure	Description	Time Frame
5 year overall survival rate

Measure	Description	Time Frame
Time to progresion and local control at 2 years

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D014508	Urea
D000577	Amides
D009930	Organic Chemicals