Please select the arm or intervention descriptions that belong 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: Arm Label: Calibration Arm; Type: EXPERIMENTAL; Interventions: Drug: fotemustine | Arm Label: Investigational Arm; Type: EXPERIMENTAL; Interventions: Drug: bevacizumab [Avastin] | Intervention Type: DRUG; Name: bevacizumab [Avastin]; Assigned to Arm(s): Investigational Arm | Intervention Type: DRUG; Name: fotemustine; Assigned to Arm(s): Calibration Arm
B: Arm Label: Arm I (radiation therapy, temozolomide, placebo); Type: ACTIVE_COMPARATOR; Interventions: Radiation: 3-Dimensional Conformal Radiation Therapy, Radiation: Intensity-Modulated Radiation Therapy, Other: Laboratory Biomarker Analysis, Other: Placebo, Other: Quality-of-Life Assessment, Drug: Temozolomide | Arm Label: Arm II (radiation therapy, temozolomide, bevacizumab); Type: EXPERIMENTAL; Interventions: Radiation: 3-Dimensional Conformal Radiation Therapy, Biological: Bevacizumab, Radiation: Intensity-Modulated Radiation Therapy, Other: Laboratory Biomarker Analysis, Other: Quality-of-Life Assessment, Drug: Temozolomide | Intervention Type: RADIATION; Name: 3-Dimensional Conformal Radiation Therapy; Assigned to Arm(s): Arm I (radiation therapy, temozolomide, placebo), Arm II (radiation therapy, temozolomide, bevacizumab) | Intervention Type: BIOLOGICAL; Name: Bevacizumab; Assigned to Arm(s): Arm II (radiation therapy, temozolomide, bevacizumab) | Intervention Type: RADIATION; Name: Intensity-Modulated Radiation Therapy; Assigned to Arm(s): Arm I (radiation therapy, temozolomide, placebo), Arm II (radiation therapy, temozolomide, bevacizumab) | Intervention Type: OTHER; Name: Laboratory Biomarker Analysis; Assigned to Arm(s): Arm I (radiation therapy, temozolomide, placebo), Arm II (radiation therapy, temozolomide, bevacizumab) | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Arm I (radiation therapy, temozolomide, placebo) | Intervention Type: OTHER; Name: Quality-of-Life Assessment; Assigned to Arm(s): Arm I (radiation therapy, temozolomide, placebo), Arm II (radiation therapy, temozolomide, bevacizumab) | Intervention Type: DRUG; Name: Temozolomide; Assigned to Arm(s): Arm I (radiation therapy, temozolomide, placebo), Arm II (radiation therapy, temozolomide, bevacizumab)
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: bevacizumab [Avastin], Drug: irinotecan | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: temozolomide | Intervention Type: DRUG; Name: bevacizumab [Avastin]; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: irinotecan; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: temozolomide; Assigned to Arm(s): 2
D: Arm Label: Cilengitide + Temozolomide + Radiotherapy; Type: EXPERIMENTAL; Interventions: Drug: Cilengitide, Drug: Temozolomide, Radiation: Radiotherapy | Arm Label: Temozolomide + Radiotherapy; Type: ACTIVE_COMPARATOR; Interventions: Drug: Temozolomide, Radiation: Radiotherapy | Intervention Type: DRUG; Name: Cilengitide; Assigned to Arm(s): Cilengitide + Temozolomide + Radiotherapy | Intervention Type: DRUG; Name: Temozolomide; Assigned to Arm(s): Cilengitide + Temozolomide + Radiotherapy, Temozolomide + Radiotherapy | Intervention Type: RADIATION; Name: Radiotherapy; Assigned to Arm(s): Cilengitide + Temozolomide + Radiotherapy, Temozolomide + Radiotherapy

Answer: A