Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Gliosarcoma
  • Recurrent Glioblastoma
Type
Interventional
Phase
Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Diagnostic

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

PRIMARY OBJECTIVES: I. To determine whether binary changes (increase versus [vs.] decrease) in rCBV within enhancing tumor from baseline to 2 weeks after initiation of anti-angiogenic therapy is associated with overall survival (OS). SECONDARY OBJECTIVES: I. To determine whether the baseline pre-tre...

PRIMARY OBJECTIVES: I. To determine whether binary changes (increase versus [vs.] decrease) in rCBV within enhancing tumor from baseline to 2 weeks after initiation of anti-angiogenic therapy is associated with overall survival (OS). SECONDARY OBJECTIVES: I. To determine whether the baseline pre-treatment rCBV measure alone is associated with OS. II. To determine whether binary changes (increase vs. decrease) in rCBV within enhancing tumor from baseline to 2 weeks after initiation of anti-angiogenic therapy is associated with progression-free survival (PFS). III. To determine whether changes in rCBV as a continuous variable within enhancing tumor from baseline to 2 weeks after initiation of anti-angiogenic therapy is associated with OS or PFS. IV. To determine the association between rCBV and OS when adjusting for the changes in enhancing tumor volume. V. To determine whether baseline cerebral blood flow (CBF) or change in CBF is associated with OS or PFS. OUTLINE: Patients undergo DSC-MRI within 3 days before bevacizumab initiation and at day 15. After completion of study intervention, patients are followed up every 3 months for 1 year and then every 6 months for up to 4 years.

Tracking Information

NCT #
NCT03115333
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jerrold Boxerman ECOG-ACRIN Cancer Research Group