A Study to Evaluate the Surgical Removal of Residual Brain Tumors Prior to Recurrence
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 20-013059
NCT ID: NCT04810871
Sponsor Protocol Number: 20-013059
About this study
The purpose of this study is to evaluate the safety and feasibility of surgical resection for pre-recurrent brain tumors. Eligible patients with surgically accessible latent tumors desiring surgical resection will be enrolled to prospectively track short- and long-term outcomes. Safety will be evaluated by quantifying rates of surgical morbidity as compared to patients undergoing RT after surgery, or no surgery for similar latent disease. Variables evaluated will include postoperative complications including death within 30 days, wound infection, length of hospital stay, and readmission rates.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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.
- 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).
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Terence Burns, M.D., Ph.D. |
Open for enrollment |
Contact information:
RST Neurologic Surgery Research Team
(507) 293-1963
|
More information
Publications
Publications are currently not available