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
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