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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00107367
First received: April 5, 2005
Last updated: January 9, 2014
Last verified: July 2009
  Purpose

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 Intervention Phase
Metastatic Cancer
Procedure: conventional surgery
Radiation: intraoperative radiation therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Local control rate as measured by MRI with contrast at 1 year [ Designated as safety issue: No ]

Estimated Enrollment: 62
Study Start Date: April 2004
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

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
Study First Received: April 5, 2005
Last Updated: January 9, 2014
Health Authority: Unspecified

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

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014