Radiation Therapy or Temozolomide in Treating Patients With Gliomas

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective than temozolomide in treating gliomas.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to temozolomide in treating patients with gliomas.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Collaborators: British Medical Research Council; NCIC Clinical Trials Group; Trans Tasman Radiation Oncology Group; Trans-Tasman Radiation Oncology Group (TROG)
• Treatments: Dacarbazine; Temozolomide

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed low-grade glioma, including any of the following types:

• Astrocytoma (gemistocytic, fibrillary, or protoplasmatic)

• Oligoastrocytoma

• Oligodendroglioma

• WHO grade II disease

• Supratentorial tumor location only

• RTOG neurological function 0-3

• Not a candidate for surgical treatment alone

• Requires treatment, as determined by ≥ 1 of the following criteria:

• Age ≥ 40 years

• Radiologically-proven progressive lesion

• New or worsening neurological symptoms other than seizures only (e.g., focal deficits, signs of increased intracranial pressure, or mental deficits)

• Intractable seizures, defined by both of the following criteria:

• Experiences persistent seizures that interfere with everyday life activities except driving a car

• Failed 3 anti-epileptic drug regimens, including ≥ 1 combination regimen

• Tumor material (paraffin-embedded) or histopathologic slides available

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• WHO 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

Hepatic

• No chronic hepatitis B or C infection

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

• AST or ALT ≤ 2.5 times ULN

• Alkaline phosphatase ≤ 2.5 times ULN

Renal

• Creatinine ≤ 1.5 times ULN

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception during and for 6 months after completion of study treatment

• No known HIV positivity

• No other serious medical condition

• No other prior or concurrent malignancy except surgically cured carcinoma in situ of the cervix or nonmelanoma skin cancer

• No psychological, familial, sociological, or geographical condition that would preclude study participation

• No medical condition that would preclude receiving oral medication (e.g., frequent vomiting or partial bowel obstruction)

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent growth factors for elevating absolute neutrophil counts for the purpose of temozolomide administration

• No concurrent epoetin alfa

• No concurrent immunotherapy or biologic therapy

Chemotherapy

• No prior chemotherapy

• No other concurrent chemotherapy, including adjuvant chemotherapy for patients randomized to undergo radiotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy to the brain

• No concurrent integrated boost with intensity-modulated radiotherapy

Surgery

• Recovered from prior surgery

• No concurrent surgical tumor debulking

Other

• No prior randomization to this study

• No other concurrent investigational drugs

• No concurrent regular use of agents known to be radiosensitizers or radioprotectors (e.g., cyclooxygenase-2 inhibitors, thalidomide, or amifostine) during study radiotherapy

• Occasional use of nonsteroidal anti-inflammatory drugs for pain allowed