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Surgical Resection of Latent Brain Tumors Prior to Recurrence

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ClinicalTrials.gov Identifier: NCT04810871
Recruitment Status : Recruiting
First Posted : March 23, 2021
Last Update Posted : July 19, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Terry Burns, Mayo Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Brain Neoplasm Procedure: Brain Surgery Not Applicable

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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Surgical Resection of Latent Brain Tumors Prior to Recurrence
Actual Study Start Date : May 6, 2021
Estimated Primary Completion Date : March 1, 2025
Estimated Study Completion Date : March 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment (surgery)
Patients undergo surgery as indicated clinically when applicable.
 Procedure: Brain Surgery
Undergo surgery


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility of surgical resection by short and long term outcomes [ Time Frame: Up to 5 years ]
    Feasibility will be evaluated by meeting enrollment criteria.

  2. Incidence of adverse events [ Time Frame: Up to 5 years ]
    Safety will be evaluated by recording adverse events utilizing proper reporting measures.


Secondary Outcome Measures :
  1. 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 ]
    Median time of survival along with 95% confidence interval will be estimated using the Kaplan-Meier method.

  2. Progression free survival [ Time Frame: Time from initial diagnosis to the date progression is identified, assessed up to 5 years ]
    Median time of progress-free survival along with the 95% confidence interval will be estimated using the Kaplan Meier method.

  3. Neurosurgical morbidity [ Time Frame: Up to completion of surgery ]
    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.

  4. 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 ]
    Median time to subsequent treatment along with the 95% confidence interval will be estimated using standard descriptive statistics.

  5. Rate of local recurrence [ Time Frame: Up to 5 years ]
    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.

  6. Rate of leptomeningeal disease [ Time Frame: Up to 5 years ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Avastin within the past 6 months for any reason
  • 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 mets)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04810871


Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Referral Office    855-776-0015    mayocliniccancerstudies@mayo.edu   
Principal Investigator: Terry C. Burns, M.D.         
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Terence C Burns Mayo Clinic in Rochester
More Information
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Responsible Party: Terry Burns, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04810871    
Other Study ID Numbers: 20-013059
NCI-2021-01950 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
20-013059 ( Other Identifier: Mayo Clinic in Rochester )
P30CA015083 ( U.S. NIH Grant/Contract )
First Posted: March 23, 2021    Key Record Dates
Last Update Posted: July 19, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Neoplasms
Recurrence
Disease Attributes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
 Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases