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Radiation Therapy

Whole Brain Radiation Therapy for Brain Metastases

Phase 3

Waitlist Available

Led By David L. Grosshans, MD,PHD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

1)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 .

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

Awards & highlights

Study Summary

This trial is testing whether immediate whole brain radiation therapy is better than observation after radiosurgery for people with 1-3 brain metastases.

Eligible Conditions

Brain Metastases

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cognitive Decline

Trial Design

2Treatment groups

Experimental Treatment

Group I: Whole Brain Radiation TherapyExperimental Treatment2 Interventions

Whole Brain Radiation Therapy

Group II: ObservationExperimental Treatment2 Interventions

Observation

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Questionnaire

2014

Completed Phase 2

~20020

Whole Brain Radiation Therapy

2008

Completed Phase 3

~240

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,975 Previous Clinical Trials

1,789,357 Total Patients Enrolled

David L. Grosshans, MD,PHDPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any spots left in this clinical trial for new patients?

"The clinical trial detailed on clinicaltrials.gov is not currently looking for new patients. Although, there are 414 other trials that are presently recruiting. This particular study was originally posted on 1/2/2001 and was most recently updated on 10/20/2022."

Answered by AI

Has the FDA greenlit Whole Brain Radiation Therapy?

"There is some evidence to support the efficacy of Whole Brain Radiation Therapy, as well as numerous reports attesting to its safety. For this reason, our team has given it a score of 3."

Answered by AI

Recent research and studies

The Lancet OncologyJournal

Neurocognition in Patients with Brain Metastases Treated with Radiosurgery or Radiosurgery Plus Whole-brain Irradiation: A Randomised Controlled Trial

Chang, Eric L, Jeffrey S Wefel, Kenneth R Hess, Pamela K Allen, Frederick F Lang, David G Kornguth, Rebecca B Arbuckle, et al.. 2009. “Neurocognition in Patients with Brain Metastases Treated with Radiosurgery or Radiosurgery Plus Whole-brain Irradiation: A Randomised Controlled Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(09)70263-3.

The Lancet OncologyJournal

Neurocognition in Patients with Brain Metastases Treated with Radiosurgery or Radiosurgery Plus Whole-brain Irradiation: A Randomised Controlled Trial

clinicaltrials.govStudy

Randomized Trial Comparing Radiosurgery With vs Without Whole Brain Radiotherapy

2001. "Randomized Trial Comparing Radiosurgery With vs Without Whole Brain Radiotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00548756.