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

Primary Purpose

Metastatic Cancer

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
conventional surgery
intraoperative radiation therapy
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Cancer focused on measuring tumors metastatic to brain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic Taussig Cancer CenterRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 5, 2005
Last Updated
January 9, 2014
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT00107367
Brief Title
Radiation Therapy in Treating Patients Who Are Undergoing Surgery to Remove a Metastatic Brain Tumor
Official Title
A Phase I/II Study Utilizing the Zeiss INTRABEAM System for the Treatment of a Resected Solitary Brain Metastasis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2004 (undefined)
Primary Completion Date
April 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
The Cleveland Clinic

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: Primary Determine the 1-year local control rate in patients undergoing resection of a solitary brain metastasis comprising intraoperative radiotherapy using the INTRABEAM® system. Secondary Determine the survival of patients treated with this therapy. Determine distant recurrence of disease in patients treated with this therapy. Determine the toxicity of this therapy in these patients. Determine the quality of life of patients treated with this therapy. OUTLINE: This is a nonrandomized study. Patients undergo surgical resection of a brain metastasis. Patients then undergo intraoperative radiotherapy using the INTRABEAM® system. Quality of life is assessed at baseline and then every 3 months for 2 years. Patients are followed within 48 hours after surgery, at 1 and 3 months, and then every 3 months for 2 years. PROJECTED ACCRUAL: A total of 31-62 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer
Keywords
tumors metastatic to brain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Masking
None (Open Label)
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Radiation
Intervention Name(s)
intraoperative radiation therapy
Primary Outcome Measure Information:
Title
Local control rate as measured by MRI with contrast at 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Weil, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente
Phone
866-223-8100

12. IPD Sharing Statement

Citations:
PubMed Identifier
25614945
Citation
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.
Results Reference
derived

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

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