NCT04810871

Surgical Resection of Latent Brain Tumors Prior to Recurrence

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	Brain Surgery	Undergo surgery

Timeline

• Start date: 2021-05-06
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2021-03-23
• Last updated: 2026-01-30

Locations

1 site across 1 country: United States