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

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ClinicalTrials.gov Identifier: NCT00107367
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : April 6, 2005
Last Update Posted : January 10, 2014
Sponsor:
Information provided by:
National Cancer Institute (NCI)

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.


Condition or disease Intervention/treatment Phase
Metastatic Cancer Procedure: conventional surgery Radiation: intraoperative radiation therapy Phase 1 Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study Utilizing the Zeiss INTRABEAM System for the Treatment of a Resected Solitary Brain Metastasis
Study Start Date : April 2004
Estimated Primary Completion Date : April 2010



Primary Outcome Measures :
  1. Local control rate as measured by MRI with contrast at 1 year


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00107367


Locations
United States, Ohio
Cleveland Clinic Taussig Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente    866-223-8100      
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Study Chair: Robert Weil, MD The Cleveland Clinic

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert Weil, Cleveland Clinic Taussig Cancer Center
ClinicalTrials.gov Identifier: NCT00107367     History of Changes
Other Study ID Numbers: CDR0000378144
CCF-IRB-7003
CCF-510K
CCF-K992577
CCF-CTSRC-1065
First Posted: April 6, 2005    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: July 2009

Keywords provided by National Cancer Institute (NCI):
tumors metastatic to brain

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes