Stereotactic Radiosurgery to the Resection Cavity Following Surgical Removal of Brain Metastasis
Recruitment status was Recruiting
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Purpose
Brain metastases (BM) are the most common intracranial tumors in adults and source of the most common neurological complications of systemic cancer. Surgery and radiation therapy are the most important components in the management of BM with the goal to prolong survival and improve the quality of life. Whole brain radiotherapy (WBRT) has shown to increase local and distant control both with and without surgical resection. However, patients who develop a new or recurrent BM after WBRT and undergo resection are left without adjuvant therapy options. Local recurrence particular in patients with single metastasis does effect both survival and quality of life. In individual cases the option of additional radiotherapy has been suggested and applied. We seek to evaluate the addition of a stereotactic radiosurgery (SRS) boost to the resection cavity both as adjuvant and salvage procedure among patients, who undergo resection of a BM and previously received WBRT or decline WBRT. Goal is to show superior local brain control.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain Neoplasms |
Procedure: Stereotactic Radiosurgery |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Single Center Prospective Phase II Study: Stereotactic Radiosurgery to the Resection Cavity Following Surgical Removal of Brain Metastasis |
- Improved local tumor control after resection [ Time Frame: 6months and 12 months ]
- Overall survival Quality of life [ Time Frame: QoL 3-6-12months and overall survival ]
| Estimated Enrollment: | 35 |
| Study Start Date: | February 2007 |
| Estimated Study Completion Date: | June 2007 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient must have undergone surgical resection of a brain metastasis
- Patients with no more than 3 brain metastases on contrast MRI.
- Previous WBRT for brain malignancy, except patients with melanoma, renal cell carcinoma.
- Adult patient aged > 18.
Patient must be in adequate general health, as indicated by:
- Karnofsky performance status equal or greater than 60.
- The absence of a concomitant life-threatening disease other than the malignancy.
- Patient must understand the investigational nature of this study and sign informed consent form, approved by the Institutional Review Board.
Exclusion Criteria:
- Pregnancy
- Patients unable or unwilling to follow protocol requirements
Contacts and Locations| Contact: Andrew A. Kanner, MD | 972-3-6974273 | andrewk@tasmc.health.gov.il |
| Contact: Lina Vizelman | 972-3-6974098 | linav@tasmc.health.gov.il |
| Israel | |
| Tel Aviv Sourasky Medical Center | Recruiting |
| Tel Aviv, Israel | |
| Contact: Andrew A Kanner, MD 972-3-6974273 andrewk@tasmc.health.gov.il | |
| Contact: Lina Vizelman 972-3-6974098 linav@tasmc.health.gov.il | |
| Principal Investigator: | Andrew A Kanner, MD | Tel Aviv Medical Center, affiliated Tel Aviv University |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00484978 History of Changes |
| Other Study ID Numbers: | 07-056 TASMC |
| Study First Received: | June 11, 2007 |
| Last Updated: | June 11, 2007 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Tel-Aviv Sourasky Medical Center:
|
Stereotactic Radiosurgery Surgery Metastatic tumor to brain radiation Brain Metastases of all pathologies |
Additional relevant MeSH terms:
|
Brain Neoplasms Neoplasms Neoplasm Metastasis Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Neoplastic Processes Pathologic Processes |
ClinicalTrials.gov processed this record on June 18, 2013