The Role of Posterior Fossa Irradiation (PFI) Plus Stereotactic Radiosurgery (SRS) for Cerebellar Metastases
Primary Purpose
Neoplasm Metastasis
Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Irradiation plus Stereotactic Radiosurgery
Sponsored by
About this trial
This is an interventional treatment trial for Neoplasm Metastasis focused on measuring irradiation, stereotactic radiosurgery, posterior fossa, cerebellar metastases
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
Sites / Locations
- Radiotherapy Department, TASMC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exp
Arm Description
Posterior Fossa Irradiation 37.5 Gy in 2.5 Gy fractions+Radiosurgical boost; Follow up:Contrast enhanced MRI & Mini Mental Status Examination
Outcomes
Primary Outcome Measures
To determine tumor control rates in the brain following posterior fossa irradiation of patients with cerebellar metastases.
Secondary Outcome Measures
To establish levels of neurocognitive performance following posterior fossa irradiation of patients with cerebellar metastases.
Full Information
NCT ID
NCT00781209
First Posted
October 26, 2008
Last Updated
October 27, 2008
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00781209
Brief Title
The Role of Posterior Fossa Irradiation (PFI) Plus Stereotactic Radiosurgery (SRS) for Cerebellar Metastases
Official Title
A Phase II Trial Evaluating the Role of Posterior Fossa Irradiation (PFI) Plus Stereotactic Radiosurgery (SRS) for Cerebellar Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
October 2008 (undefined)
Primary Completion Date
October 2009 (Anticipated)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm Metastasis
Keywords
irradiation, stereotactic radiosurgery, posterior fossa, cerebellar metastases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exp
Arm Type
Experimental
Arm Description
Posterior Fossa Irradiation 37.5 Gy in 2.5 Gy fractions+Radiosurgical boost; Follow up:Contrast enhanced MRI & Mini Mental Status Examination
Intervention Type
Procedure
Intervention Name(s)
Irradiation plus Stereotactic Radiosurgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
To determine tumor control rates in the brain following posterior fossa irradiation of patients with cerebellar metastases.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
To establish levels of neurocognitive performance following posterior fossa irradiation of patients with cerebellar metastases.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ben Corn, Prof.
Phone
972-3-6947285
Email
bencorn@tasmc.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ben Corn, Prof.
Organizational Affiliation
Radiotherapy Department, TASMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radiotherapy Department, TASMC
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marina Gurman
Phone
972-3-6974098
Email
marinag@tasmc.health.gov.il
First Name & Middle Initial & Last Name & Degree
Vika Gurevich
Phone
972-3-6947285
Email
vikag@tasmc.health.gov.il
First Name & Middle Initial & Last Name & Degree
Andrew Kanner, M.D.
First Name & Middle Initial & Last Name & Degree
Deborah Blumenthal, M.D.
First Name & Middle Initial & Last Name & Degree
Felix Bokstein, M.D.
12. IPD Sharing Statement
Learn more about this trial
The Role of Posterior Fossa Irradiation (PFI) Plus Stereotactic Radiosurgery (SRS) for Cerebellar Metastases
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