Stereotactic Radiosurgery and Radiation Therapy in Treating Patients With Glioblastoma Multiforme
Phase II Trial of Conventional Radiotherapy With Stereotactic Radiosurgery to High Risk Tumor Regions as Determined by Functional Imaging in Patients With Glioblastoma Multiforme
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.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
OBJECTIVES:
Primary
- Determine the feasibility and efficacy of stereotactic radiosurgery to high-risk tumor regions and conventional radiotherapy in patients with glioblastoma multiforme.
- Determine overall survival of patients treated with this regimen.
Secondary
- Determine 6-month progression-free survival of patients treated with this regimen.
- Determine the absence of tumor growth and/or activity on conventional MR/MR spectroscopy imaging in patients treated with this regimen.
- Determine the frequency and severity of RTOG (Radiation Therapy Oncology Group) CNS toxic effects in patients treated with this regimen.
- Determine the neurologic function and quality of life of patients treated with this regimen.
OUTLINE: This is a pilot study.
Patients undergo stereotactic radiosurgery to high-risk areas of active tumor determined by MR-spectroscopy. No more than 2 weeks later, patients undergo conventional radiotherapy once daily, 5 days a week, for 6 weeks.
Quality of life is assessed at baseline, weekly during radiotherapy, at 1 and 3 months after completion of radiotherapy, and then every 3 months for 2 years, every 6 months for 3 years, and annually thereafter.
After completion of study treatment, patients are followed periodically for at least 5 years.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
-
-
Ohio
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Cleveland, Ohio, Stati Uniti, 44106-5065
- Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
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Cleveland, Ohio, Stati Uniti, 44130
- Southwest General Health Center
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
DISEASE CHARACTERISTICS:
Histologically confirmed grade IV malignant glioblastoma multiforme
- Diagnosis by surgical biopsy or resection within the past 5 weeks
Post-operative diagnostic contrast-enhanced MRI scan with MR spectroscopy must be performed prior to initiating study treatment
High-risk area of active tumor without margin by MR spectroscopy
Meets the following criteria for radiosurgery:
- Maximum diameter ≤ 40 mm
- Located > 5 mm from the optic nerve or chiasm
- Does not involve the brainstem
- No multifocal or recurrent malignant glioma
PATIENT CHARACTERISTICS:
Performance status
- Karnofsky 50-100%
Life expectancy
- At least 3 months
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Not pregnant
- Negative pregnancy test
PRIOR CONCURRENT THERAPY:
Chemotherapy
- At least 6 weeks since chemotherapy
- Concurrent chemotherapy allowed
Endocrine therapy
- Concurrent steroids allowed, but at the smallest therapeutic dose possible
Radiotherapy
- No prior in-field radiotherapy to the head and neck
Surgery
- See Disease Characteristics
- Recovered from prior surgery or any post-operative complication
Other
- Concurrent antiseizure medications allowed
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Overall Survival After Treatment
Lasso di tempo: Minimum of 5 years.
|
Followed every 3 months for 2 years, every 6 months for 3 years, and annually thereafter for at least 5 years
|
Minimum of 5 years.
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Douglas Einstein, MD, PhD, Kettering Medical Center, Wright State University
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema nervoso
- Neoplasie per tipo istologico
- Neoplasie
- Neoplasie per sede
- Neoplasie, ghiandolari ed epiteliali
- Astrocitoma
- Glioma
- Neoplasie, Neuroepiteliali
- Tumori neuroectodermici
- Neoplasie, cellule germinali ed embrionali
- Neoplasie, tessuto nervoso
- Glioblastoma
- Neoplasie del sistema nervoso
- Neoplasie del sistema nervoso centrale
Altri numeri di identificazione dello studio
- CWRU1302
- P30CA043703 (Sovvenzione/contratto NIH degli Stati Uniti)
- CASE-CWRU-1302 (Altro identificatore: Case Comprehensive Cancer Center)
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