Clinical Trial Finder

Inclusion Criteria:

• - Histologically proven newly diagnosis of glioblastoma (WHO grade IV) - The tumor must have a supratentorial component.

• - The patient must have recovered from the effects of surgery, postoperative infection, and other complications before initial chemoradiation treatment.

• - Documentation of steroid doses within 14 days prior to initial chemoradiation treatment.

• - Karnofsky performance status ≥ 70; - Age ≥ 18.

• - Adequate renal function,hepatic function.

• - Systolic blood pressure ≤ 160 mg Hg or diastolic pressure ≤ 90 mg Hg within 14 days prior to initial chemoradiation treatment.

• - Patient must provide study specific informed consent prior to study entry.

• - Women of childbearing potential and male participants must practice adequate contraception.

• - For females of child-bearing potential, negative serum pregnancy test within 14 days prior to initial chemoradiation treatment.

Exclusion Criteria:

• - Cancer-Related Exclusion Criteria.

• - Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥3 years.

• - Recurrent or multifocal malignant gliomas.

• - Metastases detected below the tentorium or beyond the cranial vault.

• - Prior chemotherapy or radiosensitizers for cancers of the head and neck region; note that prior chemotherapy for a different cancer is allowable, except prior temozolomide or bevacizumab.

Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted.

• - Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields.

• - Haematologic, Biochemical, Organ Function and other general exclusion criteria.

• - Unstable angina and/or congestive heart failure within the last 6 months.

• - Transmural myocardial infarction within the last 6 months.

• - Evidence of recent myocardial infarction or ischemia by the findings of S-T elevations of ≥ 2mm using the analysis of an EKG performed within 14 days of initial chemoradiation treatment.

• - New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to initial chemoradiation treatment.

• - History of stroke, cerebral vascular accident (CVA) or transient ischemic attack within 6 months.

• - Serious and inadequately controlled cardiac arrhythmia.

• - Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.

• - Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of initial chemoradiation treatment.

• - Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however,that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol.

• - Inability to undergo MRI (e.g., due to safety reasons,such as presence of a pacemaker) or PET.

- Contradiction to Bevacizumab treatment

20 patients with newly diagnosed histopathologically confirmed glioblastoma (WHO Grade IV) after surgery will be enrolled in the study. All of the patients will receive conventional concurrent chemoradiation and adjuvant temozolomide plus bevacizumab begin > 3 weeks and ≤ 5 weeks after surgery.

Arms

Experimental: Chemoradiation & Adjuvant Therapy:

- Concurrent chemoradiation Therapy: - Radiation therapy:2 Gy will be given daily 5 days per week for a total of 60 Gy over 6 weeks. - Temozolomide from day 1 of radiotherapy to the last day of radiation at a daily oral dose of 75 mg/m2 for a maximum of 49 days. - Bevacizumab will be administered intravenously on days 1 and 15 of each 28-day cycle,at the beginning of the 4th week of radiation. The dose will be 10 mg/kg. - Adjuvant Therapy: - Temozolomide once per day for 5 consecutive days of a cycle. The starting dose for the first cycle will be 150 mg/m2/day, with a single dose 200 mg/m2/day in subsequent cycles if no treatment-related adverse events> grade 2 are noted. - Bevacizumab will be administered intravenously on days 1 and 15 of each 28-day cycle. The dose will be 10 mg/kg.

Interventions

Other: - Chemoradiation Therapy

- Radiation therapy:For both intensity-modulated radiation therapy (IMRT) and three-dimensional conformal radiation therapy (3D-CRT) plans, one treatment of 2 Gy will be given daily 5 days per week for a total of 60 Gy over 6 weeks. - Temozolomide will be administered continuously from day 1 of radiotherapy to the last day of radiation at a daily oral dose of 75 mg/m2 for a maximum of 49 days. - Bevacizumab will be administered intravenously on days 1 and 15 of each 28-day cycle,at the beginning of the 4th week of radiation. The dose will be 10 mg/kg of actual body weight.

Other: - Adjuvant Therapy

- Temozolomide will be administered orally once per day for 5 consecutive days (days 1-5) of a 28-day cycle. The starting dose for the first cycle will be 150 mg/m2/day, with a single dose escalation to 200 mg/m2/day in subsequent cycles if no treatment-related adverse events> grade 2 are noted. - Bevacizumab will be administered intravenously on days 1 and 15 of each 28-day cycle. The dose will be 10 mg/kg of actual body weight.