Radiation Therapy or Temozolomide in Treating Patients With Gliomas

Phase 3

Active, not recruiting

• Conditions: Brain and Central Nervous System Tumors; Cancer - Brain

• Registration Number: ACTRN12607000427471
• Lead Sponsor: European Organisation for Research and Tretment of Cancer (EORTC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-08-22
• Last Update Posted: 13 March 2023

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 709

Inclusion Criteria

At registration:
- Histologically proven low grade diffuse glioma astrocytoma WHO grade II (gemistocytic, fibrillary and protoplasmatic)
oligoastrocytoma WHO grade II oligodendroglioma WHO II
- Supratentorial location only
- WHO performance status = 2
- Not candidate for treatment exclusively by surgery
- RTOG neurological function 0-3
- Results of genetic testing (1p) available
- Adequate haematological, renal and hepatic function
- Histopathologic slides available for central pathology review
- Tumour material (paraffin-embedded) and blood available for molecular testing
- Written informed consent
At randomisation:
Same as above PLUS
- Requiring treatment as demonstrated by at least one of the following criteria (1-4):
1. Age = 40 years
2. Radiologically proven progressive lesion
3. New or worsening neurological symptoms other than seizures only (focal deficits, signs of raised intracranial pressure, mental deficits)
4. Intractable seizures, defined as having both:
persistent seizures interfering with everyday life activities other than driving a car
AND
failed three lines of anti-epileptic drug regimen, including at least one combination regimen
- RTOG Neurological Function 0-3
- Not candidate for treatment exclusively with surgery
- Must have recovered from any prior surgery
- 1p test result available (for stratification: 1p deleted versus 1p normal versus undeterminable)
- Baseline quality of life questionnaires (QLQ-C30 + BN20) completed
- Prepared to use effective contraception for the duration of the treatment and for 6 months after(applies to all patients with reproductive potential - male and female)

Exclusion Criteria

- Previous irradiation of the brain
- Previous chemotherapy
- Previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-situ of the cervix and non-melanoma skin cancer
- Known HIV infection, chronic hepatitis B or hepatitis C infection
- Any other serious medical contraindication as per the judgment of the treating physician
- Any medical condition which could interfere with oral medication intake (e.g. frequent vomiting, partial bowel obstruction)
- Female pregnant or lactating
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule as discussed with the patient before randomization

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS) - PFS is the time interval between the date of randomization and the date of disease progression or death, whichever comes first. If neither event has been observed, then the patient is censored at the date of the last follow up examination.[The first follow-up (FU) will be performed 3 months after the start of therapy, then at 3-monthly intervals until progression. After progression patients are followed every 6 months for survival until death.]

Secondary Outcome Measures

Name	Time	Method
Overall survival[Measured every 3 months until progression and then every 6 months until death];Quality of Life[Measured by QLQ-C30 v3.0 and EORTC BN-20 every 3 months until progression, and then every 6 months until death];Mini Mental State Examination[Measured every 3 months until progression and then every 6 months until death];Adverse Events[As measured by CTCAE v3.0 every 3 months until progression and then every 6 months until death.]