Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Non Comparative Phase II Trial With Bevacizumab and Fotemustine in the Treatment of Recurrent Glioblastoma
Brief Summary: This randomized, non-comparative study will evaluate the efficacy and safety of Avastin (bevacizumab) in patients with recurrent glioblastoma. Patients will be randomized to receive Avastin 10 mg/kg intravenously every 2 weeks or fotemustine 75 mg/m2 on days 1, 8 and 15, followed by, after a 5 weeks interval, 100 mg/m2 intravenously every 3 weeks. Treatment with fotemustine serves as a calibration arm and no formal efficacy comparison will be made between the two treatment arms. The anticipated time of study treatment is until disease progression or unacceptable toxicity.


Options:
A: Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Diagnosis of recurrent glioblastoma multiforme (Grade IV)
* Previous treatment with temozolomide and radiotherapy
* First recurrence after standard adjuvant treatment (surgery, followed by radiotherapy and chemotherapy)
* Adequate hematological, biochemical and organ functions

Exclusion Criteria:

* Previous treatment with Avastin or other anti-angiogenic drugs
* Residual relevant toxicity resulting from previous therapy
* Radiotherapy within the 3 months prior to the diagnosis of disease progression
* Chemotherapy in the previous 4 weeks
* Other active or inactive malignancies (except for carcinoma in situ of the cervix, of the prostate or basal cell carcinoma)
* Clinically significant cardiovascular diseases
B: Inclusion Criteria:

* Supratentorial Glioblastoma diagnosed by biopsy.
* Patients aged ≥ 70 years
* KPS \>30 and \< 70
* Life expectancy \> or = 8 weeks
* Patients were enrolled at least 14 days after stereotactic biopsy and 28 days after surgical biopsy.
* CT or brain MRI was performed within 4 weeks before treatment to rule out haemorrhage.
* Included to health social security system
* Medical assessment previous to inclusion
* Informed consent form

Exclusion Criteria:

* Previous treatment with Surgical resection, RT or chemotherapy to the tumor.
* Hemoglobin level \< 9 g%
* Absolute neutrophil count \< 1500
* Platelet count \< 100.000
* ASAT or ALAT levels more than 3 times the upper limit of normal.
* Bilirubin levels more than 2 times the upper limit of normal
* Creatinin more than 1.5 times the upper limit of normal
* Untreated high blood pressure \>150/100 mmHg
* Congestive cardiac failure
* Proteinuria \> 1 gr/24h
* INR \> 1.5 the upper limit of normal
* Recent symptomatic haemorrhage
* History of abnormal wound healing
* Gastrointestinal fistula
* Haemoptysis \> grade 2 (NCI-CTC)
* Intracranial abscess
* Coagulation disorder
* Active infection requiring intravenous antibiotics
* Vascular disease (including myocardial infarction, unstable angina, cerebrovascular disease, peripheral arterial or aortic disease) in the previous 6 months
* Malignancy diagnosed in the previous 5 years (except basocellular skin cancer and in situ cervix cancer)
* Allergy to dacarbazine, Bevacizumab, Temozolomide or their excipients, recombinant human monoclonal antibodies, or ovarian cells of Chinese hamsters.
C: Key Inclusion Criteria:

* newly diagnosed glioblastoma
* World Health Organization (WHO) performance status less than or equal to (\<=2)
* stable or decreasing corticosteroid dose within 5 days prior to randomization

Key Exclusion Criteria:

* evidence of recent hemorrhage on postoperative magnetic resonance imaging (MRI) of brain
* any prior chemotherapy or immunotherapy for glioblastomas and low grade astrocytomas
* any prior radiotherapy to brain
* clinically significant cardiovascular disease
* history of greater than or equal to (\>=) grade 2 hemoptysis within 1 month prior to randomization
* previous centralized screening for Methylguanine-DNA methyltransferase (MGMT) status for enrollment into a clinical trial
D: Inclusion Criteria:

* Radiological suspicion of a unilocular malignant glioma with distinct ring- or garland-shaped contrast agent-accumulating tumour structures and a core of reduced intensity in the MRI (central necroses) with no significant non-staining tumour tissue (exclusion of a secondary malignant glioma).
* Indication for surgical tumour resection. If radical resection is planned, the location of the contrast agent-accumulating tumour should allow complete resection.
* First operation of the tumour, no other tumour-specific pretreatment
* Karnofsky at least 70 %
* Patient's written informed consent
* Age 18-72 years

Exclusion Criteria:

* Tumour location in the midline, basal ganglia, cerebellum or brain stem
* More than one contrast agent-accumulating lesion unrelated to the primary tumour or extracerebral metastases
* Porphyria, hypersensitivity to porphyrins
* Renal insufficiency: Creatinine \> 2.0 mg/dl
* Hepatic insufficiency: Bilirubin \> 3 mg/dl
* Quick test \< 60 %
* gamma-GT \> 70 U/I
* Malignancies other than basaliomas
* Existing or planned pregnancy or lactation, or inadequate contraception
* Simultaneous participation in another clinical trial or participation in another clinical trial in the 30 days preceding randomisation

Answer: A