Primary chemotherapy with temozolomide vs. radiotherapy in patients with low grade gliomas after stratification for genetic 1p loss: a phase III study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002714-11-AT

Enrollment

699

Registered

2005-05-02

Start date

2005-06-06

Completion date

Unknown

Last updated

2014-06-02

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

Conditions

Histologically proven low-grade glioma ? Astrocytoma WHO grade II (gemistocytic, fibrillary and protoplasmatic) ? Oligoastrocytoma WHO grade II ? Oligodendroglioma WHO grade II MedDRA version: 7.1 Level: LLT Classification code 10025783

Interventions

Product Name: Temodal Pharmaceutical Form: Capsule, hard INN or Proposed INN: temozolomide CAS Number: 85622-93-1 Current Sponsor code: SCH#052365 Concentration unit: mg milligram(s) Concentration typ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: At the time of registration •Histologically proven low-grade glioma •Astrocytoma WHO grade II (gemistocytic, fibrillary and protoplasmatic) •Oligoastrocytoma WHO grade II •Oligodendroglioma WHO grade II •Supratentorial tumor location only •WHO performance status = 1.5 x109/l •Platelets >=100x109/l •Serum creatinine =1.5 times upper limit of laboratory normal •Total serum bilirubin = 1.5 times upper limit of laboratory normal •ASAT(AST) or ALAT(ALT) = 2.5 times upper limit of laboratory normal •Alkaline phosphatase of = 2.5 times upper limit of laboratory normal •Absence of known HIV infection, chronic hepatitis B or hepatitis C infection •Absence of any other serious medical condition according to the m

Exclusion criteria

Exclusion criteria: See above

Design outcomes

Primary

Measure	Time frame
Secondary Objective: to assess: • whether OS can be prolonged by primary chemotherapy with temozolomide • whether the incidence of late toxicity can be decreased by using primary chemotherapy • the toxicity profile of the two treatments and the quality of life of the patients Cytogenetic objective The impact of 1p deletions in low-grade gliomas: prognostic effect of cytogenetic deletions detected in tumors on PFS overall and by treatment group. Benefit for patients with LGGs and deletions treated with TMZ compared to radiotherapy alone with respect to survival. Interaction between treatment and cytogenetic features. ;Main Objective: To demonstrate a difference in progression-free survival for primary treatment with temozolomide versus primary irradiation.;Primary end point(s): Progression-free survival	—

Measure

Time frame

Secondary Objective: to assess: • whether OS can be prolonged by primary chemotherapy with temozolomide • whether the incidence of late toxicity can be decreased by using primary chemotherapy • the toxicity profile of the two treatments and the quality of life of the patients Cytogenetic objective The impact of 1p deletions in low-grade gliomas: prognostic effect of cytogenetic deletions detected in tumors on PFS overall and by treatment group. Benefit for patients with LGGs and deletions treated with TMZ compared to radiotherapy alone with respect to survival. Interaction between treatment and cytogenetic features. ;Main Objective: To demonstrate a difference in progression-free survival for primary treatment with temozolomide versus primary irradiation.;Primary end point(s): Progression-free survival

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Countries

Austria, Belgium, Denmark, Germany, Greece, Hungary, Italy, Portugal, Spain, Sweden, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 12, 2026