Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Phase III Study of Short Course (One-week) Radiation Therapy Versus Standard Course (Three-week) Radiation Therapy in Elderly and/or Frail Patients With Newly Diagnosed Glioblastoma Multiforme
Brief Summary: This is a multi-centre prospective, non-inferiority trial. Patients will be randomized to two treatment groups in a 1:1 ratio and will be stratified by age, Karnofsky Performance Status and extent of the surgical resection.

This study will assess the effect of a one-week radiotherapy regimen in comparison with a three-week radiotherapy regimen on the survival of elderly and/or frail patients with glioblastoma multiforme (Frail: ≥\>50 years old and with a KPS of 50% or less50%-70%; Elderly and frail: ≥65 years and with a KPS of 50% - 70%; Elderly: ≥65 years and with a KPS of 80% - 100%).


Options:
A: Inclusion Criteria:

* Histopathologically confirmed newly diagnosed glioblastoma multiforme (GBM, WHO grade IV). The histological diagnosis must have been made locally after biopsy or neurosurgical tumour resection.
* Initial surgery/biopsy at diagnosis performed \< 6 weeks (42 days) prior to randomization.
* Patient's age is 50 years or older.
* Karnofsky performance status is 50% or higher.
* Patients may have received and continue to receive corticosteroids, but they have to be on a stable or decreasing dose for at least 14 days prior to randomization.
* Patients must not have received prior chemotherapy or radiotherapy.
* Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in either English or any other language the questionnaire is officially translated into. The baseline assessment (prior to start of radiotherapy) must already have been completed. Inability (illiteracy, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the study. In centres where patients are not able to read or write, proxy interviews will be conducted in-person or via telephone by the nurse at that particular centre.
* Patient consent must be obtained according to local institutional policy. It will be the responsibility of the local participating investigators to obtain the necessary local clearance, and to indicate in writing to the IAEA Study Coordinator that such clearance has been obtained, before the trial can commence in that centre. A copy of the initial full board ERB approval and approved consent form must be sent to the Project Officer at IAEA. The patient must sign the consent form prior to randomization or registration.
* Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
* Protocol treatment is to begin within 2 weeks of patient randomization.

Exclusion Criteria:

* Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for 3 or more years.
* Patients with a serious active infection or other serious underlying medical conditions that would impair the ability of the patient to receive protocol treatment or comply with protocol.
B: Inclusion Criteria:

* Histologically confirmed supratentorial anaplastic astrocytoma or glioblastoma
* Age \> 65
* Karnofsky performance score \> 60%
* Neutrophilic granulocyte count \> 1500/µl
* Platelet count \> 100 000/µl
* Hemoglobin \> 10 g/dl
* Serum creatinine \< 1.5 times the lab's upper normal limit
* AST or ALT \< 3 times the lab's upper normal limit
* Alkaline phosphatase \< 3 times the lab's upper normal limit
* No previous systemic chemotherapy
* No previous radiotherapy to the brain
* Written consent

Exclusion Criteria:

* Serious medical or neurological condition with a poor prognosis
* HIV infection
* Second cancer requiring radiotherapy or chemotherapy (contact the study coordinat if necessary)
* Hypersensitivity to temozolomide
* Conditions associated with regular vomiting that might affect oral administration of the drugs
* Psychological, familial, social or geographical circumstances with major implications for compliance with the study visit schedule
* Patient was taking part in other intervention studies within a month of starting this study
C: DISEASE CHARACTERISTICS: Newly diagnosed oligodendroglioma or oligoastrocytoma (with at least 25% oligodendral elements) Low-grade oligodendroastrocytoma or oligodendroglioma that is recurrent after surgery without radiotherapy is allowed Prior partial or gross total resection of tumor (or biopsy only in case of no further surgical option) required At least 3 of the following histologic anaplastic features: High cellularity Endothelial abnormalities Nuclear abnormalities Necrosis Mitoses

PATIENT CHARACTERISTICS: Age: 16 to 69 Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.4 mg/dL Renal: Creatinine no greater than 1.3 mg/dL Creatinine clearance at least 60 mL/min Other: Not pregnant or nursing Fertile patients must use effective contraception No active or uncontrolled infection No other disease, including malignancy, that would preclude study No neurologic or psychiatric disturbance that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy to the skull Surgery: See Disease Characteristics
D: DISEASE CHARACTERISTICS:

* Histologically proven unifocal or multifocal, supratentorial, pure or mixed anaplastic oligodendroglioma

  * Prior suspected or proven low-grade glioma allowed if current histologic proof of pure or mixed anaplastic oligodendroglioma
* Tumor must contain an unequivocal (at least 25%) oligodendroglial element and have 2 or more anaplastic features, 1 of which must be frequent mitoses or endothelial proliferation

  * For mixed tumors, the non-oligodendroglial element must be astrocytic and the oligodendroglial or astroglial component may be anaplastic
* No evidence of spinal drop metastasis or spread to noncontiguous meninges

  * MRI of spine not required for asymptomatic patients and patients not excluded based on pathologic evidence of local meningeal infiltration by underlying tumor
* No tumor that is predominantly located in the posterior fossa (i.e., brainstem or cerebellum)
* No spinal cord tumors

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 60-100%

Life expectancy:

* Not specified

Hematopoietic:

* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 150,000/mm\^3

Hepatic:

* Bilirubin no greater than 2 times normal
* Serum glutamate oxaloacetate transaminase (SGOT) no greater than 2 times normal
* Alkaline phosphatase no greater than 2 times normal

Renal:

* Creatinine no greater than 1.5 times normal

Pulmonary:

* No chronic lung disease unless diffusion capacity of lung for carbon monoxide (DLCO) is at least 60% predicted

Other:

* No active infection
* No other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy

Endocrine therapy:

* No concurrent steroids as antiemetics
* Concurrent steroids allowed to control central nervous system (CNS) symptoms due to tumor-associated or radiotherapy-associated cerebral edema

Radiotherapy:

* No prior radiotherapy to brain or head/neck

Surgery:

* Prior surgery allowed

Answer: A