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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00781209
First Posted: October 28, 2008
Last Update Posted: October 28, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Tel-Aviv Sourasky Medical Center
  Purpose

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
Neoplasm Metastasis Procedure: Irradiation plus Stereotactic Radiosurgery Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial Evaluating the Role of Posterior Fossa Irradiation (PFI) Plus Stereotactic Radiosurgery (SRS) for Cerebellar Metastases

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • To determine tumor control rates in the brain following posterior fossa irradiation of patients with cerebellar metastases. [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • To establish levels of neurocognitive performance following posterior fossa irradiation of patients with cerebellar metastases. [ Time Frame: 1 year ]

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
Experimental: Exp
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.


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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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


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

Locations
Israel
Radiotherapy Department, TASMC Not yet recruiting
Tel Aviv, Israel, 64239
Contact: Marina Gurman    972-3-6974098    marinag@tasmc.health.gov.il   
Contact: Vika Gurevich    972-3-6947285    vikag@tasmc.health.gov.il   
Sub-Investigator: Andrew Kanner, M.D.         
Sub-Investigator: Deborah Blumenthal, M.D.         
Sub-Investigator: Felix Bokstein, M.D.         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Ben Corn, Prof. Radiotherapy Department, TASMC
  More Information

Responsible Party: Prof. Ben Corn, Radiotherapy Department, TASMC
ClinicalTrials.gov Identifier: NCT00781209     History of Changes
Other Study ID Numbers: TASMC - 08 - BC - 270 - CTIL
First Submitted: October 26, 2008
First Posted: October 28, 2008
Last Update Posted: October 28, 2008
Last Verified: October 2008

Keywords provided by Tel-Aviv Sourasky Medical Center:
irradiation
stereotactic radiosurgery
posterior fossa
cerebellar metastases

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Neoplastic Processes
Neoplasms
Pathologic Processes