Treatment for Brain Tumor

Duke University Hospital, Durham, NC
Brain Tumor+3 More Conditions
Eligibility
18+
All Sexes

Study Summary

This trial is studying two sets of treatment algorithms for brain metastases patients who have had stereotactic radiosurgery.

Eligible Conditions
  • Metastatic Brain Tumors
  • Recurrent Tumor
  • Metastatic Recurrence
  • Radiation Necrosis

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

Similar Trials

1
Stereotactic Radiosurgery
1
Hypofractionated Stereotactic Radiosurgery
1
Neuropsychological Assessment

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: From enrollment through 24 months or study exit (whichever comes first). Measurements occur at baseline, post-op visit, 1 month visit, and each subsequent follow up visit until study exit or at 24 months, whichever comes first.

Assessed for a three month period from time of randomization to steroid cessation
Radiation Necrosis Cohort
Month 24
Compare treatment approaches with respect to overall survival
Month 24
Cognitive Measure- HVLT
Cognitive Measure- Trail Making Test
Quality of Life- FACT-BR
Quality of Life- KPS
Quality of Life- NCCN Distress
Month 24
Recurrent Tumor Cohort
Month 24
Describe Quality of Life (QoL) and cognition observed over time
Month 24
Explore the relationship between radiographic features and biopsy results
Freedom from Local Progression (FFLP)
Overall Survival (OS)
Treatment failure in all cohorts/arms.

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
Stereotactic Radiosurgery
2
Hypofractionated Stereotactic Radiosurgery
1
Neuropsychological Assessment

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

0 Treatment Group

154 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · N/A

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from enrollment through 24 months or study exit (whichever comes first). measurements occur at baseline, post-op visit, 1 month visit, and each subsequent follow up visit until study exit or at 24 months, whichever comes first.

Who is running the clinical trial?

Monteris MedicalLead Sponsor
9 Previous Clinical Trials
3,471 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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References

Frequently Asked Questions

Are there any openings left in this medical research study?

"The clinical trial is currently enrolling patients, and information available on the website indicates that it was initially posted in May of 2022 with a recent update occurring June 23rd." - Anonymous Online Contributor

Unverified Answer

What is the current recruitment quota for this trial?

"Indeed, the clinicaltrials.gov website reveals that this medical research is actively enrolling patients. This trial was initially posted on May 10th 2022 and most recently updated on June 23rd of the same year; aiming to recruit 154 individuals from two distinct sites." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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