The Role of Posterior Fossa Irradiation (PFI) Plus Stereotactic Radiosurgery (SRS) for Cerebellar Metastases
NCT ID: NCT00781209
Last Updated: 2008-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2008-10-31
2010-12-31
Brief Summary
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The current study acknowledges that at least two therapeutic modalities are requisite for patients with cerebellar metastases but hypothesizes that it is unnecessary to extend the treatment of ostensibly uninvolved brain tissue beyond the limits of the posterior fossa. In so doing, it is hoped that the putative advantage derived from foregoing whole brain irradiation (e.g., reduction in neurocognitive impairment) will not be at the expense of excessive surpratentorial failure.
Detailed Description
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* Posterior Fossa Irradiation as defined by diagnostic MRI and CT simulation.
* 37.5 Gy in 2.5 Gy fractions administered via conformal beams.
* Radiosurgical boost (with dose titrated to parameters of RTOG 9005).
* Contrast enhanced MRI will be obtained at baseline and then at 3, 6, and 12 months following completion of posterior fossa irradiation.
* The Mini Mental Status Examination will be used to evaluate global cognitive function at baseline and then at 3, 6, and 12 months following completion of posterior fossa irradiation.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Exp
Posterior Fossa Irradiation 37.5 Gy in 2.5 Gy fractions+Radiosurgical boost; Follow up:Contrast enhanced MRI \& Mini Mental Status Examination
Irradiation plus Stereotactic Radiosurgery
Posterior Fossa Irradiation-total dose of 37.5 Gy in 2.5 Gy fractions administered via conformal beams.
Radiosurgical boost-total dose administered to each lesion will be titrated to the size of the metastatic focus as follows:
Maximum Tumor Diameter:\<2.0 cm; Assigned Dose:24 Gy. Maximum Tumor Diameter:2.1-3.0 cm;Assigned Dose:18 Gy. Maximum Tumor Diameter:3.1-4.0 cm;Assigned Dose:15 Gy.
Interventions
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Irradiation plus Stereotactic Radiosurgery
Posterior Fossa Irradiation-total dose of 37.5 Gy in 2.5 Gy fractions administered via conformal beams.
Radiosurgical boost-total dose administered to each lesion will be titrated to the size of the metastatic focus as follows:
Maximum Tumor Diameter:\<2.0 cm; Assigned Dose:24 Gy. Maximum Tumor Diameter:2.1-3.0 cm;Assigned Dose:18 Gy. Maximum Tumor Diameter:3.1-4.0 cm;Assigned Dose:15 Gy.
Eligibility Criteria
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Inclusion Criteria
* All primary tumors exclusive of:
* Small cell lung cancer
* Renal cell cancer (hypernephroma)
* Melanoma
* Sarcoma
* 1-3 intraparenchymal metastases
* Age ≥18 years
* RPA(14) 1 or 2
* Patients who have undergone resection are eligible provided residual disease is evident on imaging
* No clinical or radiographic evidence of progression of extracranial disease in month prior to enrollment on study.
Exclusion Criteria
* Lesions in brainstem, midbrain, pons, medulla
* Patient who have undergone complete resection of all known infratentorial disease
* Patients with leptomeningeal metastases
* Patients with hepatic metastases
* Patients with metastases from the following primary tumors are ineligible: Small Cell Lung Cancer; rena Cell Carcinoma; Melanoma; Sarcoma
* Previous cranial irradiation
18 Years
ALL
No
Sponsors
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Tel-Aviv Sourasky Medical Center
OTHER_GOV
Responsible Party
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Radiotherapy Department, TASMC
Principal Investigators
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Ben Corn, Prof.
Role: PRINCIPAL_INVESTIGATOR
Radiotherapy Department, TASMC
Locations
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Radiotherapy Department, TASMC
Tel Aviv, , Israel
Countries
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Central Contacts
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Facility Contacts
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Marina Gurman
Role: primary
Vika Gurevich
Role: backup
Other Identifiers
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TASMC - 08 - BC - 270 - CTIL
Identifier Type: -
Identifier Source: org_study_id