NCT00983359

Brief Summary

RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This phase II trial is study how well stereotactic radiation therapy works in treating patients with brain metastases

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2007

Longer than P75 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

April 1, 2007

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

June 6, 2016

Completed
Last Updated

June 6, 2017

Status Verified

May 1, 2017

Enrollment Period

5.3 years

First QC Date

September 23, 2009

Results QC Date

March 24, 2016

Last Update Submit

May 15, 2017

Conditions

Metastatic CancerUnspecified Adult Solid Tumor, Protocol Specific

Keywords

tumors metastatic to brainunspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

  • Proportion of Patients Dying of Neurological Death, Defined as Dying With Progressive Neurological Dysfunction Regardless of Systemic Disease Status

    Neurological death is defined as dying with progressive neurological dysfunction regardless of systemic disease status. Patients wtih severe neurological disability who die of intercurrent illness will also be considered to have died of neurological death.

    Up to 5 years

Secondary Outcomes (4)

  • Progression-free Survival (PFS)

    Up to 5 years

  • Time to Neurological Death

    From time of enrollment up to 5 years

  • Time to Systemic Death

    From time of enrollment up to 5 years

  • Karnofsky Decay Time

    From time of enrollment up to 5 years

Study Arms (1)

Treatment (conformal stereotactic radiation therapy)

EXPERIMENTAL

Patients undergo conformal stereotatic radiation

Radiation: Radiation Therapy

Interventions

Radiation TherapyRADIATION

Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days.

Also known as: Radiation
Treatment (conformal stereotactic radiation therapy)

Eligibility Criteria

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

You may qualify if:

  • Histology-confirmed cancer with 1 to 3 symptomatic brain metastases imaged by MRI/CT scans.
  • Have cancer not originating in central nervous system (CNS)
  • Karnofsky score of at least 60
  • Given written consent
  • At least 18 years of age

You may not qualify if:

  • Prior whole brain radiotherapy or prior focal radiotherapy of the metastasis/es considered for this trial.
  • Certain radiosensitive primary tumors such as small cell lung cancer, germ cell tumors, lymphoma, leukemia or multiple myeloma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210-1240, United States

Location

Related Publications (1)

  • Ammirati M, Kshettry VR, Lamki T, Wei L, Grecula JC. A prospective phase II trial of fractionated stereotactic intensity modulated radiotherapy with or without surgery in the treatment of patients with 1 to 3 newly diagnosed symptomatic brain metastases. Neurosurgery. 2014 Jun;74(6):586-94; discussion 594. doi: 10.1227/NEU.0000000000000325.

    PMID: 24589560RESULT

Related Links

MeSH Terms

Conditions

Neoplasm MetastasisBrain Neoplasms

Interventions

RadiotherapyRadiation

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)

TherapeuticsPhysical Phenomena

Results Point of Contact

Title
Mario Ammirati, MD
Organization
The Ohio State University Comprehensive Cancer Center
Mario.Ammirati@osumc.edu
614-293-1970

Study Officials

  • Mario Ammirati, MD

    Ohio State University Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 23, 2009

First Posted

September 24, 2009

Study Start

April 1, 2007

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

June 6, 2017

Results First Posted

June 6, 2016

Record last verified: 2017-05

Locations

US(1)