Intensity Modulated Radiotherapy with Simultaneous Boost plus Temozolomide in high grade gliomas - ND

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-003714-10-IT

Enrollment

Registered

2009-03-20

Start date

2008-06-13

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

high grade gliomas MedDRA version: 9.1 Level: LLT Classification code 10018338 Term: Glioma

Interventions

Trade Name: TEMODAL Pharmaceutical Form: Capsule, hard INN or Proposed INN: Temozolomide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? high grade (III-IV), with istological proven; ? age > 18 and =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - no brain radiationtherapy - age 80 years - RPA class VI - ECOG IV-V - Residual tumor > 8cm

Design outcomes

Primary

Measure	Time frame
Main Objective: Intensity Modulated Radiotherapy with Simultaneous Boost plus Temozolomide in high grade gliomas;Secondary Objective: ? progression free survival; ? acute toxicity ? late toxicity ? early responce to treatment with TC-Pet ;Primary end point(s): global survival	—

Countries

Italy

Outcome results

None listed

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