Recruiting

Surgery vs. No Surgery

Sponsor:

Mayo Clinic

Code:

NCT04810871

Conditions

Brain Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Brain Surgery

Study Details

Brief summary:

This clinical trial evaluates the side effects and possible benefits of operating on brain tumors prior to the tumor coming back (recurrence). Understanding when surgery is most useful to patients with brain tumors is important. Some patients may undergo chemotherapy or radiation but still have visible tumor remaining after treatment. The purpose of this research is to compare outcomes of those who have surgery after chemotherapy or radiation, but prior to tumor recurrence, to those who have surgery at a different time, or no surgery at all.

Conditions

Brain Neoplasm

Study ID

NCT04810871

Start date

May 6, 2021

Status verified date

Oct, 2026

Completion date

Mar 1, 2028

Anticipated

Primary completion date

Mar 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age >= 18 years
  • Histological or cytological confirmation of brain tumor and/or suspected brain tumor based on clinical and radiologic findings
  • Prior chemotherapy and/or radiation treatment directed to the known/suspected tumor
  • Radiographic evidence of residual or previously unresected tumor
  • Willingness to undergo surgery and sign informed consent
  • Patients not currently eligible for an alternate competing interventional clinical trial
  • Enrollment in the Mayo Clinic Cancer Center Neuro-Oncology Program Registry for the study of Nervous System Tumors (IRB#12-003458)

Exclusion Criteria:

  • Age < 18 years
  • Found to be a member of a vulnerable population (e.g. pregnant, lacking capacity to consent) during the course of pre-enrollment or pre-surgical assessment
  • Prior gross total resection of brain tumor leading to absence of visible latent disease (exemption available for post-operative enrollment)
  • Any contraindication to surgery, including anyone who in the opinion of the surgeon is at unreasonably elevated risk of wound complications
  • Patients who have not yet undergone surgery or radiation, but who would be appropriate candidates for an alternate interventional clinical trial (e.g. post-operative fractionated vs single fraction radiation to the surgical cavity for surgical brain metastases)

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (surgery)

Patients undergo surgery as indicated clinically when applicable.

Interventions

Brain Surgery

Undergo surgery

Primary outcome measure

  • Feasibility of surgical resection by short and long term outcomes [ Time Frame: Up to 5 years ]
  • Incidence of adverse events [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Terry C. Burns, MD, PhD

More Information

Sponsor

Mayo Clinic

Last update posted

Oct 7, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-10-07. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.