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Title:
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Phase III Double-blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation And Adjuvant Temozolomide Plus Bevacizumab Versus Conventional concurrent Chemoradiation and adjuvant Temozolomide In Patients with Newly Diagnosed Glioblastoma - IRB# 09-062B
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Treatments:
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Bevacizumab, RT, Temozolomide
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Disease Site:
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Brain
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Disease SubSite:
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Glioblastoma multiforme
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Drug Provided:
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Bevacizumab
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Comments:
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PPMC, PSVMC and Northwest Cancer Specialist - Vancouver are site approved to enroll both the facility questionnaire and 3D conformal RT. Credentialing has been completed.
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Eligibility:
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Histologically confirmed glioblastoma or gliosarcoma. WHO grade IV disease. Tumor must have a supratentorial component. Has undergone partial or complete surgical resection of tumor within the past 3-5 weeks. Diagnosis must be made by surgical excision (not by stereotactic biopsy). No significant postoperative hemorrhage, defined as > 1 cm diameter of blood in the tumor cavity by MRI or CT scan. Has => 1 block of tumor tissue of sufficient size available for analysis of MGMT status and determination of molecular profile. At least 1 cm³ of tissue composed primarily of tumor must be present. No CUSA (Cavitron ultrasonic aspirator)-derived material. No recurrent or multifocal malignant glioma. No metastases detected below the tentorium or beyond the cranial vault. Prior/Concurrent Therapy: Recovered from prior surgery. No prior chemotherapy or radiosensitizers for cancer of the head and neck region. Prior chemotherapy for a different cancer is allowed. No prior temozolomide or Bevacizumab. No prior Gliadel wafers or any other intratumoral or intracavitary treatment. No prior radiotherapy to the head and neck (except for T1 glottic cancer) resulting in overlap of radiotherapy fields. More than 28 days since prior major surgical procedure or open biopsy other than craniotomy for tumor resection. More than 30 days since prior and no concurrent treatment on another therapeutic clinical trial. No concurrent growth factors to induce elevations in neutrophil count for the purposes of administration of temozolomide on the scheduled dosing interval; to allow treatment with temozolomide at a higher dose; or to avoid interruption of the treatment during concurrent radiotherapy. No concurrent erythropoietin. No concurrent tumor debulking surgery, other chemotherapy, immunotherapy, biologic therapy, or additional stereotactic boost radiotherapy. No other concurrent investigational drugs during the "blinded phase” of the study. Concurrent full-dose anticoagulants (e.g.,
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Participating Sites:
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Providence Portland Medical Center, Providence St. Vincent Medical Center, Northwest Cancer Specialists - Vancouver
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