Surgical Resection of Latent Brain Tumors Prior to Recurrence

NCT04810871 | Suspended

• 2 other identifiers: 20-013059NCI-2021-01950
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Feasibility of surgical resection by short and long term outcomes

  Feasibility will be evaluated by meeting enrollment criteria.

  Up to 5 years

• Incidence of adverse events

  Safety will be evaluated by recording adverse events utilizing proper reporting measures.

  Up to 5 years

Secondary Outcomes (6)

• Overall survival

  Time from initial diagnosis to the date of death/or censored at the time of last known alive, assessed up to 5 years

• Progression free survival

  Time from initial diagnosis to the date progression is identified, assessed up to 5 years

• Neurosurgical morbidity

  Up to completion of surgery

• Time to subsequent treatment (i.e. chemotherapy/immunotherapy and/or radiation)

  Time from surgical resection at Mayo Clinic until an adjuvant treatment is administered, assessed up to 5 years

• Rate of local recurrence

  Up to 5 years

Study Arms (1)

Treatment (surgery)

EXPERIMENTAL

Patients undergo surgery as indicated clinically when applicable.

Procedure: Brain Surgery

Interventions

Brain Surgery PROCEDURE

Undergo surgery

Treatment (surgery)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Terry C. Burns, MD, PhD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 23, 2021
• Study Start: May 6, 2021
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

US (1)