NCT00003320

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy after surgery to remove brain metastases may decrease the amount of radiation required to treat brain metastases. PURPOSE: Pilot trial to study the effectiveness of radiation therapy following surgery to remove brain metastases.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 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

March 1, 1997

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.3 years until next milestone

First Posted

Study publicly available on registry

February 6, 2004

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Last Updated

August 3, 2020

Status Verified

July 1, 2012

Enrollment Period

9.4 years

First QC Date

November 1, 1999

Last Update Submit

July 30, 2020

Conditions

Metastatic Cancer

Keywords

tumors metastatic to brain

Interventions

surgical procedurePROCEDURE
radiation therapyRADIATION
stereotactic radiosurgeryRADIATION

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed cerebral metastases post surgical resection
  • No greater than 3 cerebral metastases postresection
  • Gross resection at operation as documented in operation note and postoperative MRI Patients must have current surgical sites that have not been previously irradiated
  • No other indication for whole brain irradiation (i.e., multiple untreated metastases not suitable for single fraction stereotactic radiotherapy, leptomeningeal disease)
  • Age: 18 and over
  • Karnofsky 60-100%
  • Life expectancy: At least 3 months
  • Prior or concurrent required steroids allowed
  • Prior stereotactic radiotherapy of cerebral metastases allowed provided no prior irradiation of current surgical sites
  • Prior surgery of cerebral metastases allowed

You may not qualify if:

  • severe asthma requiring therapy
  • allergy to iodine or contrast media
  • pregnant
  • concurrent chemotherapy
  • prior whole brain irradiation or focal irradiation to current sites of disease

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

MeSH Terms

Conditions

Neoplasm MetastasisBrain Neoplasms

Interventions

Surgical Procedures, OperativeRadiotherapyRadiosurgery

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)

TherapeuticsStereotaxic TechniquesNeurosurgical ProceduresInvestigative Techniques

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

February 6, 2004

Study Start

March 1, 1997

Primary Completion

August 1, 2006

Last Updated

August 3, 2020

Record last verified: 2012-07

Locations

US(1)