Surgical Resection of Latent Brain Tumors Prior to Recurrence
Primary Purpose
Brain Neoplasm
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brain Surgery
Sponsored by
About this trial
This is an interventional treatment trial for Brain Neoplasm
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
- 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)
Sites / Locations
- Mayo Clinic in RochesterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment (surgery)
Arm Description
Patients undergo surgery as indicated clinically when applicable.
Outcomes
Primary Outcome Measures
Feasibility of surgical resection by short and long term outcomes
Feasibility will be evaluated by meeting enrollment criteria.
Incidence of adverse events
Safety will be evaluated by recording adverse events utilizing proper reporting measures.
Secondary Outcome Measures
Overall survival
Median time of survival along with 95% confidence interval will be estimated using the Kaplan-Meier method.
Progression free survival
Median time of progress-free survival along with the 95% confidence interval will be estimated using the Kaplan Meier method.
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.
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.
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.
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.
Full Information
NCT ID
NCT04810871
First Posted
March 15, 2021
Last Updated
January 17, 2023
Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT04810871
Brief Title
Surgical Resection of Latent Brain Tumors Prior to Recurrence
Official Title
Surgical Resection of Latent Brain Tumors Prior to Recurrence
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 6, 2021 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
March 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
After completion of surgery, patients are followed up at 3 and 6 months, and then every 6 months thereafter.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Neoplasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment (surgery)
Arm Type
Experimental
Arm Description
Patients undergo surgery as indicated clinically when applicable.
Intervention Type
Procedure
Intervention Name(s)
Brain Surgery
Intervention Description
Undergo surgery
Primary Outcome Measure Information:
Title
Feasibility of surgical resection by short and long term outcomes
Description
Feasibility will be evaluated by meeting enrollment criteria.
Time Frame
Up to 5 years
Title
Incidence of adverse events
Description
Safety will be evaluated by recording adverse events utilizing proper reporting measures.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
Median time of survival along with 95% confidence interval will be estimated using the Kaplan-Meier method.
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
Title
Progression free survival
Description
Median time of progress-free survival along with the 95% confidence interval will be estimated using the Kaplan Meier method.
Time Frame
Time from initial diagnosis to the date progression is identified, assessed up to 5 years
Title
Neurosurgical morbidity
Description
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.
Time Frame
Up to completion of surgery
Title
Time to subsequent treatment (i.e. chemotherapy/immunotherapy and/or radiation)
Description
Median time to subsequent treatment along with the 95% confidence interval will be estimated using standard descriptive statistics.
Time Frame
Time from surgical resection at Mayo Clinic until an adjuvant treatment is administered, assessed up to 5 years
Title
Rate of local recurrence
Description
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.
Time Frame
Up to 5 years
Title
Rate of leptomeningeal disease
Description
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.
Time Frame
Up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terence C Burns
Organizational Affiliation
Mayo Clinic in Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Terry C. Burns, M.D.
12. IPD Sharing Statement
Learn more about this trial
Surgical Resection of Latent Brain Tumors Prior to Recurrence
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