NCT00138788

Brief Summary

This is a comparison of radiotherapy fractionation schemes for brain metastasis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 1996

Longer than P75 for phase_3

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

February 1, 1996

Completed
9.6 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

November 20, 2008

Status Verified

November 1, 2008

Enrollment Period

11.1 years

First QC Date

August 29, 2005

Last Update Submit

November 19, 2008

Conditions

Neoplasm MetastasisBrain Neoplasms

Keywords

RadiotherapyQualify of lifeNeoplasm metastasis of the brain

Outcome Measures

Primary Outcomes (2)

  • Progression free survival

  • Quality of life

Secondary Outcomes (4)

  • Cost effectiveness

  • Toxicity

  • Neurological functioning

  • Survival

Interventions

Radiotherapy, dose fractionationPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • ECOG performance status 0 - 2.
  • Brain metastasis. Brain biopsy not obligatory if known previous malignancy and multiple lesions typical on computed tomography (CT) scan of brain. Solitary lesions, if suitably located, should be biopsied and preferably excised.
  • Extracranial disease stable or absent (i.e. no progression over 2 months) OR concurrent presentation of brain metastasis and extracranial disease at time of initial cancer diagnosis.
  • Able to consent
  • Life expectancy exceeds 2 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Care Centre, St George Hospital

Sydney, New South Wales, 2217, Australia

Location

MeSH Terms

Conditions

Neoplasm MetastasisBrain Neoplasms

Interventions

Chemical Fractionation

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)

Chemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Associate Professor Peter H Graham

    Cancer Care Centre, St George Hospital, Sydney, Australia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 29, 2005

First Posted

August 30, 2005

Study Start

February 1, 1996

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

November 20, 2008

Record last verified: 2008-11

Locations

AU(1)