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A Phase II Trial Evaluating the Role of Posterior Fossa Irradiation (PFI) Plus Stereotactic Radiosurgery (SRS) for Cerebellar Metastases


Phase 2
18 Years
N/A
Not Enrolling
Both
Neoplasm Metastasis

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Trial Information

A Phase II Trial Evaluating the Role of Posterior Fossa Irradiation (PFI) Plus Stereotactic Radiosurgery (SRS) for Cerebellar Metastases


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.


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine tumor control rates in the brain following posterior fossa irradiation of patients with cerebellar metastases.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Ben Corn, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Radiotherapy Department, TASMC

Authority:

Israel: Ministry of Health

Study ID:

TASMC - 08 - BC - 270 - CTIL

NCT ID:

NCT00781209

Start Date:

October 2008

Completion Date:

December 2010

Related Keywords:

  • Neoplasm Metastasis
  • irradiation
  • stereotactic radiosurgery
  • posterior fossa
  • cerebellar metastases
  • Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary

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