PRIMARY CHEMOTHERAPY WITH AN EXTENDED SCHEDULE OF TEMOZOLOMIDE (1 WWEK ON / 1 WEEK OFF) FOR LOW GRADE OLIGODENDROGLIAL TUMORS AT RELAPSE OR PROGRESSION AFTER SURGERY: PHASE II TRIAL - ND
- Conditions
- GRADE II OLIGODENDORGLIOMAS AND OLIGOASTROCYTOMA AT RELAPSE OR PROGRESSIONMedDRA version: 6.1Level: PTClassification code 10030286
- Registration Number
- EUCTR2007-000386-38-IT
- Lead Sponsor
- AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- HISTOLOGICAL DIAGNOSIS OF GRADE II OLIGODENDROGLIOMAS AND OLIGOASTROCYTOMA;
- RELAPSE OR PROGRESSION OF DISEASE;
- AGE > 18 YEARS;
- ENHANCING MISURABLE LESION OF AT LEAST 1 CM IN MRI
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- HISTOLOGICAL DIAGNOSIS OF GRADE IIi OLIGODENDROGLIOMAS AND OLIGOASTROCYTOMA;
- NO PROGRESSION DISEASE;
- PREVOIUS RADIOTHERAPY OR CHEMOTHERAPY
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: VERIFY THE EFFICACY AND THE TOXICITY OF AN EXTENDED SCHEDULE OF TEMOZOLOMIDE (1 WEEK ON / 1 WEEK OFF) FOR LOW GRADE OLIGODENDROGLIAL TUMORS AT RELAPSE OR PROGRESSION AFTER SURGERY;Secondary Objective: VERIFY IF FUNCTIONAL NEUROIMMAGING TECHNIQUES AND MOLECOLAR MARKERS ARE ABLE TO DEFINE THE RESPONSE TO CHEMOTHERAPY AND SURVIVAL;Primary end point(s): RESPONSE TO CHEMOTHERAPY BASED ON MCDONAD AND HOANG-XUAN CRITERIA
- Secondary Outcome Measures
Name Time Method