Natural History of Brain Function, Quality of Life, and Seizure Control in Patients With Brain Tumor Who Have Undergone Surgery
Natural History of Postoperative Cognitive Function, Quality of Life, and Seizure Control in Patients With Supratentorial Low-Risk Grade II Glioma
4 other identifiers
observational
82
2 countries
41
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, 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2011
Typical duration for all trials
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2011
CompletedFirst Posted
Study publicly available on registry
August 16, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedMarch 18, 2015
March 1, 2015
3.2 years
August 13, 2011
March 17, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
NCF as measured by each of the 4 neurocognitive tests (DET, IDN, OCLT, GMLT)
Each of the battery's tests will be evaluated using the 2-sample t-test with a 2-sided significance level of 0.05 to determine if there is a clinically meaningful difference in the average change of NCF score from baseline to the time of radiologic tumor progression or up to 5 years (whichever occurs first) between radiologically progressed and non-progressed patients. In order to adjust for multiple comparisons and maintain the overall type I error of 0.05, Hochberg's procedure will be applied.
Up to 5 years
Secondary Outcomes (9)
Time to neurocognitive decline in patients who progress and who do not progress radiologically, as defined by the RCI-WSD
Up to 5 years
PFS
The interval from registration to progression or death, whichever occurs first, assessed up to 5 years
Radiological progression
Up to 5 years
Effect of salvage therapy on cognitive outcomes in patients who progress
Up to 5 years
QOL as measured by the EORTC QOL-30, EORTC QOL-BCN20, and EQ-5D
Up to 5 years
- +4 more secondary outcomes
Study Arms (1)
Supportive care (neurocognitive assessment and MRI)
Patients undergo neurocognitive assessment using the CogState Test battery (the DET, the IDN, the OCLT, and the GMLT) at baseline\* and at 12, 24, 36, 42, 48, 54, and 60 months. Patients also complete the EORTC QOL-30, the BCM20, and the EQ-5D questionnaires at baseline\*, at 12, 24, 36, 48, and 60 months afterwards, and before undergoing any further treatment. Patients are instructed to complete a seizure and medication diary during study. Patients undergo MRI scans at baseline\*, at 12, 24, 36, 48, and 60 months, and at the time of radiological, clinical, or neurological failure.
Interventions
Undergo neurocognitive assessment
Undergo MRI
Correlative studies
Ancillary studies
Ancillary studies
Eligibility Criteria
Central pathology-confirmed diagnosis of supratentorial grade II oligodendroglioma, astrocytome or mixed oligoastrocytoma prior to Step 2 registration. The patient must be within one of the following categories: Maximal safe resection with minimal residual disease defined as follows: * Removal of T2/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 postoperatively. * Patients who require a second surgery to obtain a maximal safe resection will be eligible if the second surgery is performed within 84 days of the inital diagnostic procedure. OR Age \<40 (any extent of resection) OR Age \<50, preoperative tumor diameter \<4 cm (any extent of resection)
You may qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Radiation Therapy Oncology Grouplead
- National Cancer Institute (NCI)collaborator
- NRG Oncologycollaborator
Study Sites (41)
The Kirklin Clinic at Acton Road
Birmingham, Alabama, 35243, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Providence Hospital
Mobile, Alabama, 36608, United States
Arizona Oncology Services Foundation
Phoenix, Arizona, 85013, United States
Arizona Oncology-Deer Valley Center
Phoenix, Arizona, 85027, United States
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
Florida Hospital
Orlando, Florida, 32803, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Queen's Medical Center
Honolulu, Hawaii, 96813, United States
University of Hawaii
Honolulu, Hawaii, 96813, United States
Hawaii Medical Center East
Honolulu, Hawaii, 96817, United States
Leeward Radiation Oncology Center
‘Ewa Beach, Hawaii, 96706, United States
Evanston CCOP-NorthShore University HealthSystem
Evanston, Illinois, 60201, United States
Covenant Medical Center
Waterloo, Iowa, 50702, United States
Norton Health Care Pavilion - Downtown
Louisville, Kentucky, 40202, United States
Norton Suburban Hospital
Louisville, Kentucky, 40207, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Barnes West County Hospital
St Louis, Missouri, 63141, United States
Billings Clinic
Billings, Montana, 59107-7000, United States
The Nebraska Medical Center
Omaha, Nebraska, 68198, United States
University of Rochester
Rochester, New York, 14642, United States
Montefiore Medical Center
The Bronx, New York, 10467-2490, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822-2001, United States
Adams Cancer Center
Gettysburg, Pennsylvania, 17325, United States
Cherry Tree Cancer Center
Hanover, Pennsylvania, 17331, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Radiation Therapy Oncology Group
Philadelphia, Pennsylvania, 19103, United States
York Hospital
York, Pennsylvania, 17405, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
Saint Vincent Hospital
Green Bay, Wisconsin, 54301, United States
Saint Mary's Hospital
Green Bay, Wisconsin, 54303, United States
Community Memorial Hospital
Menomonee Falls, Wisconsin, 53051, United States
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188, United States
London Regional Cancer Program
London, Ontario, N6A 4L6, Canada
McGill University Department of Oncology
Montreal, Quebec, H2W 1S6, Canada
Biospecimen
Tissue will be submitted to the RTOG Biospecimen Resource for the purpose of central review of pathology (mandatory fo eligibility), tissue banking, and translational research (highly recommended). For central review, H\&E slide and tumor block must be submitted. For tissue banking and translational research, remaining tissue from the central review will be used and plasma, whole blood and urine will be collected.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ali Choucair
Radiation Therapy Oncology Group
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2011
First Posted
August 16, 2011
Study Start
October 1, 2011
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
March 18, 2015
Record last verified: 2015-03