Clinical trial NCT04810871: Surgical Resection of Latent Brain Tumors Prior to Recurrence
Official title: Surgical Resection of Latent Brain Tumors Prior to Recurrence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-03-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Feasibility of surgical resection by short and long term outcomes
timeFrame: Up to 5 years
measure: Incidence of adverse events
timeFrame: Up to 5 years
Secondary outcomes:
measure: Overall survival
timeFrame: Time from initial diagnosis to the date of death/or censored at the time of last known alive, assessed up to 5 years
measure: Progression free survival
timeFrame: Time from initial diagnosis to the date progression is identified, assessed up to 5 years
measure: Neurosurgical morbidity
timeFrame: Up to completion of surgery
measure: Time to subsequent treatment (i.e. chemotherapy/immunotherapy and/or radiation)
timeFrame: Time from surgical resection at Mayo Clinic until an adjuvant treatment is administered, assessed up to 5 years
measure: Rate of local recurrence
timeFrame: Up to 5 years
measure: Rate of leptomeningeal disease
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Terry C. Burns, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: