Status:
COMPLETED
Natural History of Brain Function, Quality of Life, and Seizure Control in Patients With Brain Tumor Who Have Undergone Surgery
Lead Sponsor:
Radiation Therapy Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
NRG Oncology
Conditions:
Adult Diffuse Astrocytoma
Adult Mixed Glioma
Eligibility:
All Genders
18+ years
Brief Summary
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, ...
Detailed Description
PRIMARY OBJECTIVES: I. To determine if there is difference in the average changes of neurocognitive function (NCF) scores from baseline to the time of radiologic tumor progression or up to 5 years (w...
Eligibility Criteria
Inclusion
- 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 (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
Exclusion
Key Trial Info
Start Date :
October 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT01417507
Start Date
October 1 2011
End Date
December 1 2014
Last Update
March 18 2015
Active Locations (41)
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1
The Kirklin Clinic at Acton Road
Birmingham, Alabama, United States, 35243
2
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
3
Providence Hospital
Mobile, Alabama, United States, 36608
4
Arizona Oncology Services Foundation
Phoenix, Arizona, United States, 85013