Insight trial exams 2012
Log In. Year 12 Trial Exams. Insight Trial Exams are available for the following Year 12 subjects:. Contact Us. About Us. Remember me. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.
Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. Last Update Posted : August 11, Study Description.
Detailed Description:. FDA Resources. Arms and Interventions. Daily Radiation for a maximum of 49 days. Temozolomide will be administered orally on a daily dosing schedule Temozolomide will be administered approximately hours before each session of radiotherapy Neratinib will be taken post radiation at a daily oral pre-determine dose.
Outcome Measures. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Inclusion Criteria: Participants must have histologically confirmed intracranial glioblastoma or gliosarcoma following maximum surgical resection.
Tumors primarily localized in the infratentorial compartment will be excluded. Participants may have had prior surgery for glioblastoma or gliosarcoma but no systemic or radiation therapy. Participants must plan to begin radiation therapy days after surgical resection. Evidence that the tumor MGMT promoter is unmethylated by standard of care assays. Genotyping data available or in process data must be available at time of initial registration if randomization probabilities differ across biomarker subgroups as determined by the DFCI Coordinating Center to assign biomarker subgroups through whole exome sequencing, whole genome copy number analysis, or a combination as described in Section 9.
MRI with gadolinium should be obtained within 21 days prior to beginning treatment. Patients without measurable disease are eligible. The effects of the experimental agents used in this study on the developing human fetus are unknown.
Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Participants will not be eligible if the original diagnosis was a lower grade glioma and a subsequent histologic diagnosis revealed glioblastoma. Planned major surgery. Participants who are receiving any other investigational agents.
Participants who have had any prior cranial radiotherapy. Patients who meet the above listed criteria and are only on preventative treatment will be deemed eligible. History of intratumoral or peritumoral hemorrhage if deemed significant by the treating physician.
Complete left bundle branch or bifascicular block. Persistent or history of clinically meaningful ventricular arrhythmias or atrial fibrillation. Other clinically significant heart disease such as congestive heart failure requiring treatment. Subjects must be free of any clinically relevant disease other than glioma that would, in the treating investigator's opinion, interfere with the conduct of the study or study evaluations.
Known active Hepatitis B e. Known acute or chronic pancreatitis. Active infection requiring antibiotics. Pregnant or breastfeeding. Impairment of gastrointestinal GI function or GI disease that may significantly alter the absorption of study drug e.
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