CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 35 enrolled
Drug / intervention
radiation therapy +1 moreradiation
Likely dose
Conventional radiotherapy once daily, 5 days per week for 6 weeks, plus stereotactic radiosurgery to high-risk areasAI-extracted
Key inclusion· 7
  • Histologically confirmed grade IV glioblastoma multiforme
  • Diagnosis by surgical biopsy or resection within 5 weeks
  • Post-operative contrast-enhanced MRI with MR spectroscopy identifying high-risk area of active tumor
  • High-risk tumor area meets SRS criteria: maximum diameter ≤40 mm, >5 mm from optic nerve/chiasm, no brainstem involvement
Key exclusion· 3
  • Multifocal or recurrent malignant glioma
  • Prior in-field radiotherapy to head and neck
  • Pregnant or positive pregnancy test

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00253448
NCT00253448Phase 2Completed

Phase II Trial of Conventional Radiotherapy With Stereotactic Radiosurgery to High Risk Tumor Regions as Determined by Functional Imaging in Patients With Glioblastoma Multiforme

Case Comprehensive Cancer Center·interventional·Posted Nov 15, 2005·Updated Aug 29, 2011

In Brief

A Phase 2 clinical trial evaluating radiation therapy and stereotactic radiosurgery for Brain and Central Nervous System Tumors. Completed, enrolled 35 participants across 2 sites.

Detailed Summary

RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving stereotactic radiosurgery together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving stereotactic radiosurgery together with radiation therapy works in treating patients with glioblastoma multiforme.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 15, 2005
Enrollment StartDec 1, 2002
Primary CompletionDec 1, 2009
Study CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 7 yearsPosted 20.6 years ago

Interventions

radiation therapyradiation

No more than 2 weeks later, patients undergo conventional radiotherapy once daily, 5 days a week, for 6 weeks.

stereotactic radiosurgeryradiation

stereotactic radiosurgery to high-risk areas of active tumor determined by MR-spectroscopy