The Role of Posterior Fossa Irradiation (PFI) Plus Stereotactic Radiosurgery (SRS) for Cerebellar Metastases
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|ClinicalTrials.gov Identifier: NCT00781209|
Recruitment Status : Unknown
Verified October 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was: Not yet recruiting
First Posted : October 28, 2008
Last Update Posted : October 28, 2008
The aggregate of data pertaining to brain metastases suggests that optimal results are achievable with a 2-pronged approach that addresses both the specific focus (with surgery or radiosurgery) and the surrounding brain parenchymal tissue that may harbor micrometastases. Patterns of failure following treatment of metastases that arise in the posterior fossa have not been reliably defined. Although most would agree that radiosurgery alone is not sufficient treatment for focal metastases in the cerebellum, it may be possible to deliver less than WBI as an "expanded port" beyond the SRS volume.
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.
|Condition or disease||Intervention/treatment||Phase|
|Neoplasm Metastasis||Procedure: Irradiation plus Stereotactic Radiosurgery||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial Evaluating the Role of Posterior Fossa Irradiation (PFI) Plus Stereotactic Radiosurgery (SRS) for Cerebellar Metastases|
|Study Start Date :||October 2008|
|Estimated Primary Completion Date :||October 2009|
|Estimated Study Completion Date :||December 2010|
Posterior Fossa Irradiation 37.5 Gy in 2.5 Gy fractions+Radiosurgical boost; Follow up:Contrast enhanced MRI & Mini Mental Status Examination
Procedure: 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.
- To determine tumor control rates in the brain following posterior fossa irradiation of patients with cerebellar metastases. [ Time Frame: 1 year ]
- To establish levels of neurocognitive performance following posterior fossa irradiation of patients with cerebellar metastases. [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00781209
|Contact: Ben Corn, Prof.||email@example.com|
|Radiotherapy Department, TASMC||Not yet recruiting|
|Tel Aviv, Israel, 64239|
|Contact: Marina Gurman 972-3-6974098 firstname.lastname@example.org|
|Contact: Vika Gurevich 972-3-6947285 email@example.com|
|Sub-Investigator: Andrew Kanner, M.D.|
|Sub-Investigator: Deborah Blumenthal, M.D.|
|Sub-Investigator: Felix Bokstein, M.D.|
|Principal Investigator:||Ben Corn, Prof.||Radiotherapy Department, TASMC|