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Sponsored by: |
Tel-Aviv Sourasky Medical Center |
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Information provided by: | Tel-Aviv Sourasky Medical Center |
ClinicalTrials.gov Identifier: | NCT00781209 |
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 | Intervention | Phase |
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Neoplasm Metastasis |
Procedure: Irradiation plus Stereotactic Radiosurgery |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | A Phase II Trial Evaluating the Role of Posterior Fossa Irradiation (PFI) Plus Stereotactic Radiosurgery (SRS) for Cerebellar Metastases |
Estimated Enrollment: | 30 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Exp: Experimental
Posterior Fossa Irradiation 37.5 Gy in 2.5 Gy fractions+Radiosurgical boost; Follow up:Contrast enhanced MRI & Mini Mental Status Examination
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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. |
SCHEMA:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
All primary tumors exclusive of:
Exclusion Criteria:
Contact: Ben Corn, Prof. | 972-3-6947285 | bencorn@tasmc.health.gov.il |
Israel | |
Radiotherapy Department, TASMC | |
Tel Aviv, Israel, 64239 |
Principal Investigator: | Ben Corn, Prof. | Radiotherapy Department, TASMC |
Responsible Party: | Radiotherapy Department, TASMC ( Prof. Ben Corn ) |
Study ID Numbers: | TASMC - 08 - BC - 270 - CTIL |
Study First Received: | October 26, 2008 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00781209 |
Health Authority: | Israel: Ministry of Health |
irradiation stereotactic radiosurgery posterior fossa cerebellar metastases |
Neoplasm Metastasis |
Neoplasms Neoplastic Processes Pathologic Processes |