The Role of Posterior Fossa Irradiation (PFI) Plus Stereotactic Radiosurgery (SRS) for Cerebellar Metastases
Recruitment status was Not yet recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: 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 |
- To determine tumor control rates in the brain following posterior fossa irradiation of patients with cerebellar metastases. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- To establish levels of neurocognitive performance following posterior fossa irradiation of patients with cerebellar metastases. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Ben Corn, Prof. | 972-3-6947285 | bencorn@tasmc.health.gov.il |
| 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. | |
| Principal Investigator: | Ben Corn, Prof. | Radiotherapy Department, TASMC |
More Information
No publications provided
| Responsible Party: | Prof. Ben Corn, Radiotherapy Department, TASMC |
| ClinicalTrials.gov Identifier: | NCT00781209 History of Changes |
| Other Study ID Numbers: | TASMC - 08 - BC - 270 - CTIL |
| Study First Received: | October 26, 2008 |
| Last Updated: | October 27, 2008 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Tel-Aviv Sourasky Medical Center:
|
irradiation stereotactic radiosurgery posterior fossa cerebellar metastases |
Additional relevant MeSH terms:
|
Neoplasms Neoplasm Metastasis Neoplasms, Second Primary Neoplastic Processes Pathologic Processes |
ClinicalTrials.gov processed this record on June 17, 2013