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Title Natural History of Postoperative Cognitive Function, Quality of Life, and Seizure Control in Patients with Supratentorial Low-Risk Grade II Glioma

IRB RTOG0925

CC 13-474

Hospital Main Campus

Disease Brain

Description

1. 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.

1. To determine if there is difference in the time to neurocognitive decline, as defined by the RCIWSD (denotes: Reliable change index -- within-subjects standard deviation), between radiologically progressed and non-progressed patients.
2. 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.
3. To determine if the changes in cognitive functioning are an early warning biomarker for radiological progression.
4. To explore the effect of salvage therapy on cognitive outcomes in patients who progress during the study period for up to 5 years.
5. To evaluate QOL as measured by the EORTC QOL-30 and QOL BCN20 brain module and health utilities as measured by the EQ-5D, for a total time on study of 5 years.
6. To evaluate seizure control for a total time on study of 5 years.
7. To evaluate molecular correlates of QOL, NCF, seizure control, and PFS.
8. To characterize aberrant molecular pathways in LGGs and test the hypothesis that activation of signaling pathways will predict worse PFS and overall survival (OS).
9. 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).

Inclusion Criteria

1. Central pathology-confirmed diagnosis of supratentorial grade II oligodendroglioma, astrocytoma, or mixed oligoastrocytoma prior to Step 2 registration
2. No multifocal disease, based upon the following minimum diagnostic work-up
3. History/physical examination, including neurologic examination, within 84 days prior to Step 2 registration
4. 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)
5. KPS ≥ 80
6. Age ≥ 18
7. Registration must occur within 84 days from most recent surgery
8. The patient must be within one of the following categories:
   1. Maximal safe resection with minimal residual disease defined as follows:
      1. 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.
      2. 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 postoperatively) to confirm resolution of edema. MRI at the time of enrollment must document a ≤ 2 cm residual maximal tumor diameter/T2 FLAIR abnormality
      3. 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 OR
      4. Age < 40 (any extent of resection) OR
      5. Age < 50 and preoperative tumor diameter < 4 cm (any extent of resection)
      1. Patient must provide study-specific informed consent prior to Step 1 registration.
      2. No plans for adjuvant radiotherapy or chemotherapy after surgery. This is an observational trial.

Exclusion Criteria

1. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years [1095 days] (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible);
2. Inability to undergo MRI of the brain with gadolinium
3. Recurrence for this tumor
4. Prior surgery, radiation therapy, and/or chemotherapy for this tumor