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

NCT00781209 | Unknown Phase 2

• 1 other identifier: TASMC - 08 - BC - 270 - CTIL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasm Metastasis

Keywords

irradiation; stereotactic radiosurgery; posterior fossa; cerebellar metastases

Outcome Measures

Primary Outcomes (1)

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

  1 year

Secondary Outcomes (1)

• To establish levels of neurocognitive performance following posterior fossa irradiation of patients with cerebellar metastases.

  1 year

Study Arms (1)

Exp

EXPERIMENTAL

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

Interventions

Irradiation plus Stereotactic Radiosurgery 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.

Exp

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed malignant disease
• All primary tumors exclusive of:
• Small cell lung cancer
• Renal cell cancer (hypernephroma)
• Melanoma
• Sarcoma
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Radiotherapy Department, TASMC

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Radiation; Radiosurgery

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Phenomena; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ben Corn, Prof.

  Radiotherapy Department, TASMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ben Corn, Prof.

CONTACT

972-3-6947285; bencorn@tasmc.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: October 26, 2008
• First Posted: October 28, 2008
• Study Start: October 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: December 1, 2010
• Last Updated: October 28, 2008

Record last verified: 2008-10

Locations

IL (1)