NCT00548756

Brief Summary

The goal of this clinical research study is to learn if your thinking ability (cognitive function) will be better preserved by delivering whole brain radiation therapy immediately after radiosurgical treatment of 1-3 brain metastases or to carefully observe patients after radiosurgery and hold back whole brain radiation therapy until the disease comes back.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2001

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

January 2, 2001

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2007

Completed
15.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2023

Completed
Last Updated

June 7, 2023

Status Verified

June 1, 2023

Enrollment Period

22.4 years

First QC Date

October 22, 2007

Last Update Submit

June 6, 2023

Conditions

Brain Cancer

Keywords

Brain CancerWhole Brain Radiation TherapyQuality of LifeQOLQuestionnaireSurveyWBRT

Outcome Measures

Primary Outcomes (1)

  • Cognitive Decline

    Cognitive decline objectively measured by significant deterioration in HVLT-R LEARN at 4 months (i.e., a drop by at least 5 points compared to baseline). Difference between pretreatment baseline score and follow-up assessment scores determined by using the reliable change index (RCI).

    4 months

Study Arms (2)

Whole Brain Radiation Therapy

EXPERIMENTAL

Whole Brain Radiation Therapy

Procedure: Whole Brain Radiation TherapyBehavioral: Questionnaire

Observation

OTHER

Observation

Other: ObservationBehavioral: Questionnaire

Interventions

Whole Brain Radiation TherapyPROCEDURE

Whole Brain Radiation Therapy. Total dose = 30 Gy over 12 fractions at 2.5Gy per fraction.

Also known as: WBRT
Whole Brain Radiation Therapy
ObservationOTHER

Patients who did not receive whole brain radiation and develop recurrent disease shall receive treatment based on the number of lesions.

Observation
QuestionnaireBEHAVIORAL

Questionnaire taking 40 minutes to complete.

Also known as: Survey
ObservationWhole Brain Radiation Therapy

Eligibility Criteria

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

You may qualify if:

  • )age 18 and older at time of registration. 2) recursive partitioning class (RPA) I or II. 3) 1 to 3 newly diagnosed brain metastases 4) must be eligible to have all lesions treated by SRS as determined by the radiation oncologist on the basis of location and size. 5)MRI with contrast must be performed with 1 month of registration. 6)Signed informed consent form approved by the IRB agreeing to randomization .

You may not qualify if:

  • \) prior WBRT 2) prior resection of brain metastasis, SRS or Gamma knife. 3) \> 3 brain metastases present on MRI 4) lymphoma, small cell lung cancer, leukemia, germ cell tumors. 5) leptomeningeal disease. 6) unknown primary.7) RPA Class III (i.e. KPS \< 70) 8) pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Chang EL, Wefel JS, Hess KR, Allen PK, Lang FF, Kornguth DG, Arbuckle RB, Swint JM, Shiu AS, Maor MH, Meyers CA. Neurocognition in patients with brain metastases treated with radiosurgery or radiosurgery plus whole-brain irradiation: a randomised controlled trial. Lancet Oncol. 2009 Nov;10(11):1037-44. doi: 10.1016/S1470-2045(09)70263-3. Epub 2009 Oct 2.

    PMID: 19801201DERIVED

Related Links

MeSH Terms

Conditions

Brain Neoplasms

Interventions

ObservationSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative TechniquesData CollectionEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • David L. Grosshans, MD,PHD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 22, 2007

First Posted

October 24, 2007

Study Start

January 2, 2001

Primary Completion

June 2, 2023

Study Completion

June 2, 2023

Last Updated

June 7, 2023

Record last verified: 2023-06

Locations

US(1)