Natural History of Brain Function, Quality of Life, and Seizure Control in Patients with Brain Tumor Who Have Undergone Surgery
Overview
Tab Title Description
Study type
ObservationalDescribes 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: 11-008547
- Scottsdale/Phoenix, Arizona: 11-008547
NCT ID: NCT01417507
Sponsor Protocol Number: RTOG 0925
About this study
This trial studies the natural history of brain function, quality of life, and seizure control in patients with brain tumor who have undergone surgery. Learning about brain function, quality of life, and seizure control in patients with brain tumor who have undergone surgery may help doctors learn more about the disease and find better methods of treatment and on-going care.
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:
- Central pathology confirmed diagnosis of supratentorial grade II oligodendroglioma, astrocytoma, or mixed oligoastrocytoma prior to step 2 registration
- No multifocal disease, based upon the following minimum diagnostic work-up:
- History/physical examination, including neurologic examination, within 84 days prior to step 2 registration
- Brain MRI with and without contrast within 84 days prior to Step 2 registration (Note: MRI 70 days after surgery is preferred and highly encouraged)
- The patient must be within one of the following categories:
- Maximal safe resection with minimal residual disease defined as follows:
- Removal of T2/fluid-attenuated inversion recovery (FLAIR) abnormalities thought to be primarily tumor, with a residual ≤ 2 cm maximal tumor diameter/T2 FLAIR abnormality on MRI to be done within 84 days post-operatively
- If there is > 2 cm post-operative residual T2/FLAIR abnormality and the neurosurgeon believes this represents edema and not primarily tumor, the neurosurgeon is encouraged to repeat imaging within the allowed study period (up to 84 days post-operatively) to confirm resolution of edema
- MRI at the time of enrollment must document a ≤ 2 cm residual maximal tumor diameter/T2 FLAIR abnormality
- Patients who required a second surgery to obtain a maximal safe resection will be eligible if the second surgery is performed within 84 days of the initial diagnostic procedure
- Age < 40 (any extent of resection)
- Age < 50 and preoperative tumor diameter < 4 cm (any extent of resection)
- Karnofsky performance status ≥ 80%
- No prior invasive malignancy (except non-melanomatous skin cancer) unless disease-free for a minimum of 3 years [1,095 days] (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
- Must be able to undergo MRI of the brain with gadolinium
- No plans for adjuvant radiotherapy or chemotherapy after surgery
- No more than 84 days (12 weeks) since prior surgery
- No brain tumor recurrence
- No prior brain tumor surgery, radiation therapy and/or chemotherapy
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 Nadia Laack, M.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
855-776-0015
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Nadia Laack, M.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
855-776-0015
|
More information
Publications
Publications are currently not available