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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-000386-38-IT
Enrollment
Unknown
Registered
2007-05-04
Start date
2007-04-26
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

GRADE II OLIGODENDORGLIOMAS AND OLIGOASTROCYTOMA AT RELAPSE OR PROGRESSION MedDRA version: 6.1 Level: PT Classification code 10030286

Interventions

Trade Name: TEMODAL*1FL 5CPS 100MG Product Name: temozolimide Pharmaceutical Form: Tablet INN or Proposed INN: Temozolomide Concentration unit: mg milligram(s) Concentration type: equal Concentration

Sponsors

AZIENDA SANITARIA OSPEDALIERA "S. GIOVANNI BATTISTA DI TORINO"
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: - HISTOLOGICAL DIAGNOSIS OF GRADE IIi OLIGODENDROGLIOMAS AND OLIGOASTROCYTOMA; - NO PROGRESSION DISEASE; - PREVOIUS RADIOTHERAPY OR CHEMOTHERAPY

Design outcomes

Primary

MeasureTime frame
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—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026