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Early Brain Surgery for Brain Tumor

N/A
Recruiting
Led By Terence C Burns
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histological or cytological confirmation of brain tumor and/or suspected brain tumor based on clinical and radiologic findings
Age >= 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing whether surgery on brain tumors before they come back is more effective than surgery at a different time or no surgery.

Who is the study for?
This trial is for adults over 18 who've had chemo or radiation for brain tumors but still have some tumor left. They must be willing to undergo surgery, not be pregnant or unable to consent, and can't have had a complete tumor removal before. They should also not qualify for other clinical trials.Check my eligibility
What is being tested?
The study looks at the timing of brain surgery in treating tumors that haven't recurred yet. It compares outcomes between those having early surgery after chemo/radiation and those who wait or don’t get operated on at all.See study design
What are the potential side effects?
Potential side effects include typical risks associated with brain surgery such as infection, bleeding, neurological damage, reaction to anesthesia, and complications from wound healing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My brain tumor diagnosis was confirmed through lab tests or imaging.
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I am 18 years old or older.
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I have had chemotherapy or radiation for my tumor.
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I am willing to have surgery and understand the risks involved.
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I have tumors that haven't been removed or still show on scans.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of surgical resection by short and long term outcomes
Incidence of adverse events
Secondary outcome measures
Neurosurgical morbidity
Overall survival
Progression free survival
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (surgery)Experimental Treatment1 Intervention
Patients undergo surgery as indicated clinically when applicable.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,207 Previous Clinical Trials
3,767,100 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,481 Total Patients Enrolled
Terence C BurnsPrincipal InvestigatorMayo Clinic in Rochester
4 Previous Clinical Trials
391 Total Patients Enrolled

Media Library

Brain Surgery Clinical Trial Eligibility Overview. Trial Name: NCT04810871 — N/A
Brain Tumor Research Study Groups: Treatment (surgery)
Brain Tumor Clinical Trial 2023: Brain Surgery Highlights & Side Effects. Trial Name: NCT04810871 — N/A
Brain Surgery 2023 Treatment Timeline for Medical Study. Trial Name: NCT04810871 — N/A

Frequently Asked Questions

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

How many individuals are actively taking part in this experiment?

"Affirmative, the information on clinicaltrials.gov verifies that this experiment is currently looking for volunteers to join. It was first announced on May 6th 2021 and has been recently updated on July 18th 2022 with a requirement of 40 individuals between 1 site."

Answered by AI

Is recruitment still open for participation in this experiment?

"Affirmative. According to the information hosted on clinicaltrials.gov, this particular experiment was initially posted on May 6th 2021 and is currently recruiting patients with most recent updates occurring on July 18th 2022. 40 volunteers are required from one location for participation in this study."

Answered by AI

What outcomes is this research project attempting to accomplish?

"This medical study, conducted over a period of up to 5 years, primarily measures the incidence of adverse events. Secondary outcomes evaluated include neurosurgical morbidity (postoperative complications such as wound infection and neurologic deficits), hospital stay duration, readmission rates and progression-free survival. To analyse these data points, the research team will be employing standard descriptive statistics along with Kaplan Meier methods for calculating median timeframes alongside 95% confidence intervals. Finally, information on subsequent treatments (e.g chemotherapy/immunotherapy & radiation) are also logged via descriptive stats and their associated medians/confidence intervals calculated."

Answered by AI
~9 spots leftby Mar 2025