Stereotactic Radiosurgery to the Resection Cavity Following Surgical Removal of Brain Metastasis

NCT00484978 | Unknown Phase 2

• 1 other identifier: 07-056 TASMC
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Neoplasms

Keywords

Stereotactic Radiosurgery; Surgery; Metastatic tumor to brain; radiation; Brain Metastases of all pathologies

Outcome Measures

Primary Outcomes (1)

• Improved local tumor control after resection

  6months and 12 months

Secondary Outcomes (1)

• Overall survival Quality of life

  QoL 3-6-12months and overall survival

Interventions

Stereotactic Radiosurgery PROCEDURE

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy
• Patients unable or unwilling to follow protocol requirements

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Andrew A Kanner, MD

  Tel Aviv Medical Center, affiliated Tel Aviv University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew A. Kanner, MD

CONTACT

972-3-6974273; andrewk@tasmc.health.gov.il

Lina Vizelman

CONTACT

972-3-6974098; linav@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: June 11, 2007
• First Posted: June 12, 2007
• Study Start: February 1, 2007
• Study Completion: June 1, 2007
• Last Updated: June 12, 2007

Record last verified: 2007-06

Locations

IL (1)