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.
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Institut Gustave Roussy.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Institut Gustave Roussy
Information provided by:
Institut Gustave Roussy
ClinicalTrials.gov Identifier:
NCT00180973
First received: September 13, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
LOCALLY ADVANCED UNDIFFERENTIATED CARCINOMA NASOPHARYNGEAL TYPE UCNT |
Drug: Hydroxyurea |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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. |
Resource links provided by NLM:
Further study details as provided by Institut Gustave Roussy:
Eligibility| Ages Eligible for Study: | 15 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00180973 History of Changes |
| Other Study ID Numbers: | VUMCA2, CSET 94/346 |
| Study First Received: | September 13, 2005 |
| Last Updated: | September 13, 2005 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Carcinoma Nasopharyngeal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Neoplasms by Site Nasopharyngeal Diseases Pharyngeal Diseases |
Stomatognathic Diseases Otorhinolaryngologic Diseases Hydroxyurea Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antisickling Agents Hematologic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013