Surgical Resection of Latent Brain Tumors Prior to Recurrence

NCT ID: NCT04810871

Last Updated: 2026-01-30

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-06
• Study Completion Date: 2028-03-01

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.

Detailed Description

PRIMARY OBJECTIVE:

I. To evaluate the safety and feasibility of surgical resection for pre-recurrent brain tumors.

SECONDARY OBJECTIVES:

I. To determine whether there are differences in overall survival for patients who receive radiation therapy (RT) prior to surgery as compared to patients who receive RT after surgery or patients undergoing no further surgery.

II. To determine for patients having pre-recurrent surgery whether there is a longer interval to local/regional progression, any central nervous system (CNS) progression or need for subsequent intracranial treatment compared to patients receiving post-operative RT, time to each will be separately documented.

III. To determine for patients with pre-operative as compared to post-operative fractionated radiation for brain metastases (mets) whether there is a decreased rate of local recurrence.

IV. To determine for patients with pre-operative as compared to post-operative fractionated radiation for brain mets whether there is a decreased rate of leptomeningeal disease.

CORRELATIVE RESEARCH OBJECTIVES:

I. To determine the genetic and molecular alterations occurring in radiated brain and radiated tumor tissue compared to nonradiated tissue specimens (subjects will be matched to Mayo Clinic Cancer Center Neuro-Oncology Program Registry for the study of Nervous System Tumors 12-003458).

II. To investigate the relative sensitivity of radiated human CNS tumors to senolytic or other therapies in ex vivo assays targeting radiation-induced biology to promote synthetic lethality using cryopreserved or fresh tissue.

III. To investigate the availability and utility of candidate biomarkers reflective of tumor burden and therapeutic susceptibility, from tissue, cerebrospinal fluid (CSF) and peripheral blood.

IV. Patients self-reported outcomes may be obtained through the Neurosurgery Registry program. As available, these data may be referenced as a screening tool for any impact on quality of life (QOL) associated with trial participation as compared to matched controls.

OUTLINE:

Patients undergo surgery as indicated clinically when applicable. Patients also undergo magnetic resonance imaging (MRI) or computed tomography (CT) throughout the study and may optionally undergo tissue sample collection on study.

After completion of surgery, patients are followed up at 3 and 6 months, and then every 6 months thereafter.

Conditions

Brain Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (surgery)

Patients undergo surgery as indicated clinically when applicable.

Group Type: EXPERIMENTAL

Brain Surgery

Intervention Type: PROCEDURE

Undergo surgery

Interventions

Brain Surgery

Undergo surgery

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Terry C. Burns, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

NCI-2021-01950

Identifier Type: REGISTRY

Identifier Source: secondary_id

20-013059

Identifier Type: OTHER

Identifier Source: secondary_id

20-013059

Identifier Type: -

Identifier Source: org_study_id