The Role of Posterior Fossa Irradiation (PFI) Plus Stereotactic Radiosurgery (SRS) for Cerebellar Metastases

NCT ID: NCT00781209

Last Updated: 2008-10-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2010-12-31

Brief 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.

Detailed Description

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.

Conditions

Neoplasm Metastasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exp

Posterior Fossa Irradiation 37.5 Gy in 2.5 Gy fractions+Radiosurgical boost; Follow up:Contrast enhanced MRI \& Mini Mental Status Examination

Group Type: EXPERIMENTAL

Irradiation plus Stereotactic Radiosurgery

Intervention Type: PROCEDURE

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

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Radiotherapy Department, TASMC

Principal Investigators

Ben Corn, Prof.

Role: PRINCIPAL_INVESTIGATOR

Radiotherapy Department, TASMC

Locations

Radiotherapy Department, TASMC

Tel Aviv, , Israel

Countries

Israel

Central Contacts

Ben Corn, Prof.

Role: CONTACT

bencorn@tasmc.health.gov.il

972-3-6947285

Facility Contacts

Marina Gurman

Role: primary

marinag@tasmc.health.gov.il

972-3-6974098

Vika Gurevich

Role: backup

vikag@tasmc.health.gov.il

972-3-6947285

Other Identifiers

TASMC - 08 - BC - 270 - CTIL

Identifier Type: -

Identifier Source: org_study_id