NCT00003324

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1997

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.5 years until next milestone

First Posted

Study publicly available on registry

April 25, 2003

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Last Updated

August 3, 2020

Status Verified

July 1, 2012

Enrollment Period

8.6 years

First QC Date

November 1, 1999

Last Update Submit

July 30, 2020

Conditions

Metastatic Cancer

Keywords

tumors metastatic to brain

Interventions

conventional surgeryPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • and over
  • Karnofsky 60-100%
  • Life expectancy:At least 3 months
  • Concurrent steroids allowed

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Related Publications (1)

  • Chitapanarux I, Goss B, Vongtama R, Frighetto L, De Salles A, Selch M, Duick M, Solberg T, Wallace R, Cabatan-Awang C, Ford J. Prospective study of stereotactic radiosurgery without whole brain radiotherapy in patients with four or less brain metastases: incidence of intracranial progression and salvage radiotherapy. J Neurooncol. 2003 Jan;61(2):143-9. doi: 10.1023/a:1022173922312.

    PMID: 12622453RESULT

MeSH Terms

Conditions

Neoplasm MetastasisBrain Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Judith M. Ford, MD, PhD

    Jonsson Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

April 25, 2003

Study Start

December 1, 1997

Primary Completion

July 1, 2006

Last Updated

August 3, 2020

Record last verified: 2012-07

Locations

US(1)