Radiation Therapy in Treating Patients Who Are Undergoing Surgery to Remove a Metastatic Brain Tumor

NCT00107367 | Unknown Phase 1

• 5 other identifiers: CDR0000378144CCF-IRB-7003CCF-510KCCF-K992577CCF-CTSRC-1065
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Specialized radiation therapy that delivers radiation directly to the area where a tumor was surgically removed may kill any remaining tumor cells and cause less damage to normal tissue. PURPOSE: This phase I/II trial is studying radiation therapy to see how well it works in treating patients who are undergoing surgery to remove a metastatic brain tumor.

Conditions

Metastatic Cancer

Keywords

tumors metastatic to brain

Outcome Measures

Primary Outcomes (1)

• Local control rate as measured by MRI with contrast at 1 year

Interventions

conventional surgery PROCEDURE

intraoperative radiation therapy RADIATION

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Newly diagnosed supratentorial solitary brain metastasis by enhanced MRI or CT scan * Resectable disease * Histological evidence of metastatic carcinoma by intraoperative pathology * No primary lymphoma, germ cell carcinoma, or small cell lung cancer PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 70-100% Life expectancy * At least 3 months Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Cardiovascular * No uncontrolled hypertension * No unstable angina pectoris * No uncontrolled dysrhythmias Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No serious infection * No other medical illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior temozolomide or polifeprosan 20 with carmustine implant (Gliadel® wafer) for brain metastasis Endocrine therapy * Not specified Radiotherapy * No prior brain radiotherapy of any kind, including local or whole brain external beam radiotherapy, brachytherapy, or stereotactic radiosurgery * No concurrent external beam radiotherapy to the brain * Not planning adjuvant whole brain radiotherapy after study therapy Surgery * Not specified Other * No other prior conventional or investigational local or systemic agents for brain metastasis

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

RECRUITING

Related Publications (1)

• Weil RJ, Mavinkurve GG, Chao ST, Vogelbaum MA, Suh JH, Kolar M, Toms SA. Intraoperative radiotherapy to treat newly diagnosed solitary brain metastasis: initial experience and long-term outcomes. J Neurosurg. 2015 Apr;122(4):825-32. doi: 10.3171/2014.11.JNS1449. Epub 2015 Jan 23.

  PMID: 25614945 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis; Brain Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Robert Weil, MD

  The Cleveland Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 5, 2005
• First Posted: April 6, 2005
• Study Start: April 1, 2004
• Primary Completion: April 1, 2010
• Last Updated: January 10, 2014

Record last verified: 2009-07

Locations

US (1)