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OpenTrials
Completed

NCT Number: NCT00003324

Radiation Therapy With or Without Surgery in Treating Patients Who Have Brain Metastases

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells in a single high dose. Combining radiation therapy with surgery may be a more effective treatment for brain metastases.

PURPOSE: Clinical trial to study the effectiveness of radiation therapy with or without surgery in treating patients who have brain metastases.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

About this study

OBJECTIVES:

  • Develop prognostic factors for patients with brain metastases treated by focal treatment without concurrent whole brain irradiation.
  • Determine whether focal treatment without whole brain radiotherapy produces good long-term outcome in patients with four or less cerebral metastases.
  • Assess survival, physical and cognitive functioning, and quality of life of patients treated on this protocol.

OUTLINE: Quality of life is assessed using the FACT-BR scale, physical function is assessed using the FIM scale, and cognition is assessed using two brief pencil and paper tests.

Patients receive focal therapy for cerebral metastases by any combination of (1) surgery plus fractionated stereotactic radiotherapy to surgical bed, or (2) single fraction stereotactic radiotherapy by linear accelerator with or without a radiation sensitizer.

Patients are followed at 2 and 10 weeks, then every 3 months for 18 months, then every 6 months for 3 years, then annually. Quality of life is assessed at each followup visit.

Patients suffering intracerebral relapse are offered further focal therapy if they have no more than 3 metastases, no more than 6 lesions over consecutive scans, and continue to have life expectancy of at least 3 months and Karnofsky performance status of 60-100%. Otherwise, relapsed patients are offered whole brain radiotherapy or supportive treatment with steroids, and may also receive stereotactic boost to the new lesions. Patients who have received prior whole brain irradiation will be offered entry into other protocols if eligible or supportive treatment with steroids. Patients are followed as above.

PROJECTED ACCRUAL: At least 60 patients will be enrolled in this study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Biopsy, CT scan, or MRI proven cerebral metastases with known current or previous systemic malignancy OR
  • Biopsy proven cerebral metastases other than from small cell lung cancer or lymphoma
  • Refused whole brain radiation therapy OR
  • Received prior whole brain radiation therapy and ineligible for other relapse protocols
  • 18 and over
  • Karnofsky 60-100%
  • Life expectancy:At least 3 months
  • Concurrent steroids allowed

Exclusion criteria

  • more than four cerebral metastases on MRI scan and suitable for focal treatment with surgery and/or stereotactic radiotherapy with a linear accelerator
  • more than 2 weeks since prior focal radiation
  • more than 2 weeks since prior focal surgery

Treatment and study plan

conventional surgery

Procedure

radiation therapy

Radiation

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Registry information

Official study title

Prognostic Factors Associated With Successful Omission of Whole Brain Radiotherapy in Patients With 4 or Less Cerebral Metastases Treated With Focal Radiation or Surgery

Important dates

Study start
1997
Primary completion
2006
First posted
Apr 25, 2003
Registry last updated
Aug 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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