Psychosocial Effects of Cancer and Its Treatment Clinical Trial
Official title:
Natural History of Postoperative Cognitive Function, Quality of Life, and Seizure Control in Patients With Supratentorial Low-Risk Grade II Glioma
Verified date | March 2015 |
Source | Radiation Therapy Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 82 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Canada | London Regional Cancer Program | London | Ontario |
Canada | McGill University Department of Oncology | Montreal | Quebec |
United States | Piedmont Hospital | Atlanta | Georgia |
United States | Billings Clinic | Billings | Montana |
United States | The Kirklin Clinic at Acton Road | Birmingham | Alabama |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Montefiore Medical Center | Bronx | New York |
United States | Carolinas Medical Center | Charlotte | North Carolina |
United States | University of Cincinnati | Cincinnati | Ohio |
United States | Geisinger Medical Center | Danville | Pennsylvania |
United States | Evanston CCOP-NorthShore University HealthSystem | Evanston | Illinois |
United States | Leeward Radiation Oncology Center | Ewa Beach | Hawaii |
United States | Adams Cancer Center | Gettysburg | Pennsylvania |
United States | Saint Mary's Hospital | Green Bay | Wisconsin |
United States | Saint Vincent Hospital | Green Bay | Wisconsin |
United States | Cherry Tree Cancer Center | Hanover | Pennsylvania |
United States | Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania |
United States | Hawaii Medical Center East | Honolulu | Hawaii |
United States | Queen's Medical Center | Honolulu | Hawaii |
United States | University of Hawaii | Honolulu | Hawaii |
United States | Norton Health Care Pavilion - Downtown | Louisville | Kentucky |
United States | Norton Suburban Hospital | Louisville | Kentucky |
United States | Community Memorial Hospital | Menomonee Falls | Wisconsin |
United States | Froedtert and the Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | Providence Hospital | Mobile | Alabama |
United States | Christiana Care Health System-Christiana Hospital | Newark | Delaware |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | The Nebraska Medical Center | Omaha | Nebraska |
United States | Florida Hospital | Orlando | Florida |
United States | Radiation Therapy Oncology Group | Philadelphia | Pennsylvania |
United States | Arizona Oncology Services Foundation | Phoenix | Arizona |
United States | Arizona Oncology-Deer Valley Center | Phoenix | Arizona |
United States | Mayo Clinic | Rochester | Minnesota |
United States | University of Rochester | Rochester | New York |
United States | Barnes West County Hospital | Saint Louis | Missouri |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah |
United States | Mayo Clinic in Arizona | Scottsdale | Arizona |
United States | Covenant Medical Center | Waterloo | Iowa |
United States | Waukesha Memorial Hospital | Waukesha | Wisconsin |
United States | York Hospital | York | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Radiation Therapy Oncology Group | National Cancer Institute (NCI), NRG Oncology |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Time to neurocognitive decline in patients who progress and who do not progress radiologically, as defined by the RCI-WSD | The cumulative incidence approach will be used to estimate the median time to neurocognitive impairment to account for the competing risk of death and to determine if there is a clinically meaningful difference in the time to neurocognitive decline, as defined by the RCI-WSD (reliable change index—within-subjects standard deviation), between radiologically progressed and non-progressed patients. | Up to 5 years | No |
Secondary | PFS | Estimated using the Kaplan-Meier method, and difference between the activation of different signaling pathways will be tested using the log rank test. Multivariate analyses with the Cox proportional hazards model for PFS will be performed to assess the activation of the signaling pathway effect adjusting for patient-specific risk factors. The covariates to be evaluated for the multivariate models are: activation of signaling pathway status, age, tumor size, and other prognostic factors. | The interval from registration to progression or death, whichever occurs first, assessed up to 5 years | No |
Secondary | Radiological progression | To determine if the NCF decline is an earlier warning biomarker to radiologic progression, we will use NCF change as a time-dependent covariate in a Cox proportional hazards (PH) regression model with radiological progression as the endpoint. The Cox model estimates the ratio of hazard rate of radiographic failure with and without neurocognitive decline. Anticonvulsant use, tumor size, tumor histology, and further treatment received if recurrence is discovered, which may also have impact on the radiological progression, will also be considered in this Cox PH regression analysis. | Up to 5 years | No |
Secondary | Effect of salvage therapy on cognitive outcomes in patients who progress | Up to 5 years | No | |
Secondary | QOL as measured by the EORTC QOL-30, EORTC QOL-BCN20, and EQ-5D | The general linear mixed-effects model will be used to evaluate the changes of QOL and health utilities over time. | Up to 5 years | No |
Secondary | Frequency of seizures, evaluated using patient seizure diary | Marginal models will be used to evaluate the change of frequencies of seizures over time for up to 5 years. Anticonvulsant use, tumor size, tumor histology, further treatment received if recurrence is discovered, and other prognostic factors will also be included in the covariates sets. The available molecular marker information will also be included as a covariate to evaluate the molecular correlates of seizure frequency. | Up to 5 years | No |
Secondary | Molecular correlates of QOL, NCF, seizure control, and PFS | Up to 5 years | No | |
Secondary | OS | Estimated using the Kaplan-Meier method, and difference between the activation of different signaling pathways will be tested using the log rank test. Multivariate analyses with the Cox proportional hazards model for OS will be performed to assess the activation of the signaling pathway effect adjusting for patient-specific risk factors. The covariates to be evaluated for the multivariate models are: activation of signaling pathway status, age, tumor size, and other prognostic factors. | Up to 5 years | No |
Secondary | Symptomatic or clinical progression | Symptomatic and clinical progression will be explored for the correlation with cognitive changes in addition to radiological progression. | Up to 5 years | No |
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