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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Approved-not yet active 18 and over Other TASMC - 08 - BC - 270 - CTIL NCT00781209

Trial Description

Summary

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.

Further Study Information

SCHEMA:

• 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.

Eligibility Criteria

Inclusion Criteria:

• Histologically confirmed malignant disease

• 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:

• Major psychiatric illness

• 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Tel-Aviv Sourasky Medical Center

Ben Corn, Prof.

Principal Investigator

Ben Corn, Prof.		Ph: 972-3-6947285
		Email: bencorn@tasmc.health.gov.il

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00781209
Information obtained from ClinicalTrials.gov on October 28, 2008