Recruiting
Phase 1
Phase 2

Radiation Therapy

Sponsor:

The Cleveland Clinic

Code:

NCT00107367

Conditions

Metastatic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

conventional surgery

intraoperative radiation therapy

Study Details

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

Study ID

NCT00107367

Start date

Apr, 2004

Status verified date

Jul, 2009

Primary completion date

Apr, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

62 participants

Anticipated

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

conventional surgery

intraoperative radiation therapy

Primary outcome measure

  • Local control rate as measured by MRI with contrast at 1 year [ Time Frame: undefined ]

Central Contacts and Locations

Locations

Cleveland Clinic Taussig Cancer Center

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente

866-223-8100

More Information

Sponsor

The Cleveland Clinic

Last update posted

Jan 10, 2014

Last verified

Jul, 2009

Keywords

  • tumors metastatic to brain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2014-01-10.