Evaluating primary chemotherapy with temozolomide continuative low dose in patients with low grade gliomas grade II WHO - Continuative temozolomide in low grade gliomas

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-001545-34-IT

Enrollment

Registered

2006-04-21

Start date

2006-03-22

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

First line chemotherapy in low grade glioma MedDRA version: 6.1 Level: PT Classification code 10060971

Interventions

Trade Name: TEMODAL 5 CPS 20 MG Pharmaceutical Form: Capsule, hard INN or Proposed INN: Temozolomide CAS Number: 85622-93-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histologically proven low grade diffuse glioma Astrocytoma WHO grade II gemistocytic, fibrillary and protoplasmatic , Oligoastrocytoma WHO grade II and oligodendroglioma WHO II; Newly diagnosed; Requiring treatment as demonstrated by at least one of the following criteria 1. measurable disease after surgery or biopsy 2. Prior radiotherapy, if any, have to be completed at least 8 weeks before enrollment 3. Neurological symptoms others than seizures only focal deficits, signs of increased intracranial pressure, mental deficits ; 4. Intractable/drug-resistent seizures; 5. Age 40 years; Karnofsky PS 60; Adequate hematological, renal and hepatic function; No prior chemotherapy; Written informed consent 1p/19q FISH analysis 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: Recurrent/progressive low grade astrocytoma with histological or radiological signs of anaplastic progression.

Design outcomes

Primary

Measure	Time frame
Main Objective: Progression free survival;Secondary Objective: Clinical benefit Toxicity;Primary end point(s): Progression free survival 12-24 months	—

Countries

Italy

Outcome results

None listed

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