Brain NeoplasmNCT04810871
Surgical Resection of Latent Brain Tumors Prior to Recurrence
A study testing Brain Surgery in people with Brain Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Neoplasm
- What is being tested?
- Brain Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2021to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Terry C. Burns, MD, PhD
About this study
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the safety and feasibility of surgical resection for pre-recurrent brain tumors.
SECONDARY OBJECTIVES:
- 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:
- 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
- Being tested
- Brain Surgery
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain SurgeryProcedure or surgery
Undergo surgery
| Study group | Role | What they receive |
|---|---|---|
| Treatment (surgery) | Experimental | Patients undergo surgery as indicated clinically when applicable. Receives: Procedure: Brain Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of surgical resection by short and long term outcomes
Feasibility will be evaluated by meeting enrollment criteria.
Measured: Up to 5 years
Incidence of adverse events
Safety will be evaluated by recording adverse events utilizing proper reporting measures.
Measured: Up to 5 years
Secondary outcomes (6)
Overall survival
Median time of survival along with 95% confidence interval will be estimated using the Kaplan-Meier method.
Measured: 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
Median time of progress-free survival along with the 95% confidence interval will be estimated using the Kaplan Meier method.
Measured: Time from initial diagnosis to the date progression is identified, assessed up to 5 years
Neurosurgical morbidity
Postoperative complications such as wound infection and neurologic deficits will be logged. Additional metrics including hospital stay and readmission rates will also be logged. Standard descriptive statistics will be used to summarize the outcomes.
Measured: Up to completion of surgery
Time to subsequent treatment (i.e. chemotherapy/immunotherapy and/or radiation)
Median time to subsequent treatment along with the 95% confidence interval will be estimated using standard descriptive statistics.
Measured: Time from surgical resection at Mayo Clinic until an adjuvant treatment is administered, assessed up to 5 years
Rate of local recurrence
Will be logged as a categorical value and continuous data - endpoint is diagnosis of local recurrent disease. The presence and time to local recurrent disease will be logged and standard descriptive statistics will be used to summarize the outcomes.
Measured: Up to 5 years
Rate of leptomeningeal disease
Will be logged as both a categorical value and continuous data - endpoint is diagnosis of leptomeningeal disease. The presence and time to occurrence of leptomeningeal disease will be logged and standard descriptive statistics will be used to summarize the outcomes.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start6 May 2021
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Terry C. Burns, MD, PhD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810871
- Sponsor's protocol ID
- 20-013059
- Other IDs
- NCI-2021-01950, 20-013059
- Status last verified
- Oct 2026
- First submitted
- 15 Mar 2021
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Resection of Latent Brain Tumors Prior to Recurrence
- ClinicalTrials.gov ID
- NCT04810871
- Acronym / sponsor ID
- 20-013059
- Conditions
- Brain Neoplasm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 6 May 2021 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 23 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate the safety and feasibility of surgical resection for pre-recurrent brain tumors.
SECONDARY OBJECTIVES:
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (surgery) | Experimental | Procedure: Brain SurgeryPatients undergo surgery as indicated clinically when applicable. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain SurgeryUndergo surgery | Procedure or surgery | Treatment (surgery) |
Primary outcome
Feasibility of surgical resection by short and long term outcomes
Time frame: Up to 5 years
Feasibility will be evaluated by meeting enrollment criteria.
Incidence of adverse events
Time frame: Up to 5 years
Safety will be evaluated by recording adverse events utilizing proper reporting measures.
6 secondary outcomes
Overall survival
Time frame: 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 frame: Time from initial diagnosis to the date progression is identified, assessed up to 5 years
Neurosurgical morbidity
Time frame: Up to completion of surgery
Time to subsequent treatment (i.e. chemotherapy/immunotherapy and/or radiation)
Time frame: Time from surgical resection at Mayo Clinic until an adjuvant treatment is administered, assessed up to 5 years
Rate of local recurrence
Time frame: Up to 5 years
Rate of leptomeningeal disease
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Terry C. Burns, MD, PhD principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain Surgery in people with Brain Neoplasm, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of surgical resection by short and long term outcomes (time frame: Up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.