Natural History of Brain Function, Quality of Life, and Seizure Control in Patients With Brain Tumor Who Have Undergone Surgery
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Purpose
RATIONALE: 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.
PURPOSE: This trial studies the natural history of brain function, quality of life, and seizure control in patients with brain tumor who have undergone surgery.
| Condition | Intervention |
|---|---|
|
Brain and Central Nervous System Tumors Cognitive/Functional Effects Neurotoxicity Psychosocial Effects of Cancer and Its Treatment Seizure |
Other: laboratory biomarker analysis Other: questionnaire administration Other: study of socioeconomic and demographic variables Procedure: cognitive assessment Procedure: contrast-enhanced magnetic resonance imaging Procedure: magnetic resonance imaging Procedure: psychosocial assessment and care Procedure: quality-of-life assessment |
| Study Type: | Observational |
| Official Title: | Natural History of Postoperative Cognitive Function, Quality of Life, and Seizure Control in Patients With Supratentorial Low-Risk Grade II Glioma |
- NCF as measured by each of the 4 neurocognitive tests periodically for 5 years [ Designated as safety issue: No ]
- Time to neurocognitive decline as defined by the RCI-WSD [ Designated as safety issue: No ]
- PFS [ Designated as safety issue: No ]
- Association of cognitive function and radiological progression [ Designated as safety issue: No ]
- Effect of salvage therapy on cognitive outcomes in patients who progress [ Designated as safety issue: No ]
- QOL as measured by the EORTC QLQ-C30, EORTC QLQ-BCN20, and EQ-5D [ Designated as safety issue: No ]
- Frequency of seizures [ Designated as safety issue: No ]
- Molecular correlates of QOL, NCF, seizure control, and PFS [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Association between change in cognitive function and symptomatic progression or clinical progression [ Designated as safety issue: No ]
| Estimated Enrollment: | 170 |
| Study Start Date: | October 2011 |
| Estimated Primary Completion Date: | September 2016 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- 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 (whichever occurs first), between radiologically progressed and non-progressed patients.
Secondary
- To determine if there is difference in the time to neurocognitive decline, as defined by the RCI-WSD (denotes: Reliable change index - within-subjects standard deviation), between radiologically progressed and non-progressed patients.
- To evaluate NCF during the postoperative observational period of progression-free survival (PFS) and after radiological progression for a total time on study of 5 years.
- To determine if the changes in cognitive functioning are an early warning biomarker for radiological progression.
- To explore the effect of salvage therapy on cognitive outcomes in patients who progress during the study period for up to 5 years.
- To evaluate quality-of-life (QOL) as measured by the EORTC QOL-30 and QOL BCN20 brain module and health utilities as measured by the European Quality of Life-5 Dimensions (EQ-5D), for a total time on study of 5 years.
- To evaluate seizure control for a total time on study of 5 years.
- To evaluate molecular correlates of QOL, NCF, seizure control, and PFS.
- To characterize aberrant molecular pathways in low-grade gliomas (LGGs) and test the hypothesis that activation of signaling pathways will predict worse PFS and overall survival (OS).
- To explore the relationship between change in cognitive function and symptomatic progression (defined as worsening seizures or new or progressive neurologic deficits) or clinical progression (defined as initiation of treatment interventions such as radiotherapy, chemotherapy, or additional surgery).
OUTLINE: This is a multicenter study.
Patients undergo neurocognitive assessment using the CogState Test battery (the Detection Test [DET], the Identification Test [IND], the One Card Learning Test [OCLT], and the Groton Maze Learning Test [GMLT]) at baseline* and at 12, 24, 36, 42, 48, 54, and 60 months. Patients also complete the EORTC Quality of Life Questionnaire-Core 30 (QOL-30), the Brain Cancer Module-20 (BCM20), and the European Quality of Life-5 Dimensions (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.
Patients may undergo plasma, whole blood, and urine sample collection for molecular studies. Remaining tissue samples after central review may be also collected.
NOTE: * 12 weeks after surgery.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Central pathology confirmed diagnosis of supratentorial grade II oligodendroglioma, astrocytoma, or mixed oligoastrocytoma
No multifocal disease, based upon the following minimum diagnostic work-up:
- History/physical examination, including neurologic examination, within 84 days
- 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)
PATIENT CHARACTERISTICS:
- 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
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No more than 84 days (12 weeks) since prior surgery
- No plans for adjuvant radiotherapy or chemotherapy after surgery
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Walter John Curran, Jr, Winship Cancer Institute of Emory University |
| ClinicalTrials.gov Identifier: | NCT01417507 History of Changes |
| Other Study ID Numbers: | CDR0000708271, RTOG-0925 |
| Study First Received: | August 13, 2011 |
| Last Updated: | October 5, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
cognitive/functional effects psychosocial effects of cancer and its treatment neurotoxicity seizure |
adult mixed glioma adult oligodendroglioma adult diffuse astrocytoma |
Additional relevant MeSH terms:
|
Nervous System Neoplasms Seizures Central Nervous System Neoplasms Neurotoxicity Syndromes Neoplasms by Site Neoplasms Nervous System Diseases |
Epilepsy Brain Diseases Central Nervous System Diseases Neurologic Manifestations Signs and Symptoms Poisoning Substance-Related Disorders |
ClinicalTrials.gov processed this record on May 22, 2013