Ignite Creation Date:
2024-05-06 @ 3:57 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04810871
Status:
RECRUITING
Last Update Posted:
2024-02-12
First Post:
2021-03-15
Brief Title:
Surgical Resection of Latent Brain Tumors Prior to Recurrence
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Surgical Resection of Latent Brain Tumors Prior to Recurrence
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 localregional 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
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 localregional 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20-013059 | OTHER | Mayo Clinic in Rochester | None |
| NCI-2021-01950 | REGISTRY | None | None |