Clinical trial · Observational
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
NCT01417507CI-TRIAL-00017163completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Diffuse Astrocytoma | Adult Diffuse Astrocytoma | ONTOLOGY_EXACT | 0.98 |
| Adult Mixed Glioma | Adult Mixed Glioma | ONTOLOGY_EXACT | 0.98 |
| Adult Oligodendroglioma | Adult Oligodendroglioma | ONTOLOGY_EXACT | 0.98 |
| Cognitive/Functional Effects | — | UNRESOLVED | — |
| Neurotoxicity | — | UNRESOLVED | — |
| Psychosocial Effects of Cancer and Its Treatment | — | UNRESOLVED | — |
| Seizure | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cognitive assessment | Procedure | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| magnetic resonance imaging | Procedure | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Supportive care (neurocognitive assessment and MRI)
- description
- 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.
- interventionNames
- Procedure: cognitive assessment
- Procedure: magnetic resonance imaging
- Other: laboratory biomarker analysis
- Other: questionnaire administration
- Procedure: quality-of-life assessment
Primary outcomes (1)
- measure
- NCF as measured by each of the 4 neurocognitive tests (DET, IDN, OCLT, GMLT)
- timeFrame
- Up to 5 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 chemotherapyReferences
Publications (0)
Data not yet available
No reference posted for this study.