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


N/A
18 Years
N/A
Open (Enrolling)
Both
Adult Diffuse Astrocytoma, Adult Mixed Glioma, Adult Oligodendroglioma, Cognitive/Functional Effects, Neurotoxicity, Psychosocial Effects of Cancer and Its Treatment, Seizure

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Trial Information

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


PRIMARY OBJECTIVES:

I. 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 OBJECTIVES:

I. To determine if there is difference in the time to neurocognitive decline, as defined by
the Reliable Change Index - Within subjects Standard Deviation (RCI-WSD), between
radiologically progressed and non-progressed patients.

II. 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.

III. To determine if the changes in cognitive functioning are an early warning biomarker for
radiological progression.

IV. To explore the effect of salvage therapy on cognitive outcomes in patients who progress
during the study period for up to 5 years.

V. To evaluate quality-of-life (QOL) as measured by the European Organization for Research
and Treatment of Cancer (EORTC) QOL-30 and QOL brain module (BCN20) and health utilities as
measured by the European Quality of Life-5 Dimensions (EQ-5D), for a total time on study of
5 years.

VI. To evaluate seizure control for a total time on study of 5 years. VII. To evaluate
molecular correlates of QOL, NCF, seizure control, and PFS. VIII. 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).

IX. 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:

Patients undergo neurocognitive assessment using the CogState Test battery (the Detection
Test (DET), the Identification Test (IDN), 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.

NOTE: * 12 weeks after surgery.


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 [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

- No plans for adjuvant radiotherapy or chemotherapy after surgery

- No more than 84 days (12 weeks) since prior surgery

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

NCF as measured by each of the 4 neurocognitive tests (DET, IDN, OCLT, GMLT)

Outcome 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.

Outcome Time Frame:

Up to 5 years

Safety Issue:

No

Principal Investigator

Ali Choucair

Investigator Role:

Principal Investigator

Investigator Affiliation:

Radiation Therapy Oncology Group

Authority:

United States: Institutional Review Board

Study ID:

RTOG 0925

NCT ID:

NCT01417507

Start Date:

October 2011

Completion Date:

Related Keywords:

  • Adult Diffuse Astrocytoma
  • Adult Mixed Glioma
  • Adult Oligodendroglioma
  • Cognitive/Functional Effects
  • Neurotoxicity
  • Psychosocial Effects of Cancer and Its Treatment
  • Seizure
  • Astrocytoma
  • Glioma
  • Oligodendroglioma
  • Seizures
  • Neurotoxicity Syndromes

Name

Location

Mayo ClinicRochester, Minnesota  55905
Washington University School of MedicineSaint Louis, Missouri  63110
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
York HospitalYork, Pennsylvania  17315
Community Memorial HospitalMenomonee Falls, Wisconsin  53051
Waukesha Memorial HospitalWaukesha, Wisconsin  53188
Carolinas Medical CenterCharlotte, North Carolina  28232-2861
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Montefiore Medical CenterBronx, New York  10467-2490
Piedmont HospitalAtlanta, Georgia  30309
Arizona Oncology Services FoundationPhoenix, Arizona  85013
Leeward Radiation Oncology CenterEwa Beach, Hawaii  96706
Mayo Clinic in ArizonaScottsdale, Arizona  85259-5404
Queen's Medical CenterHonolulu, Hawaii  96813
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Providence HospitalMobile, Alabama  36608
University of RochesterRochester, New York  14642
Radiation Therapy Oncology GroupPhiladelphia, Pennsylvania  19107
Huntsman Cancer Institute/University of UtahSalt Lake City, Utah  84112
Florida HospitalOrlando, Florida  32803
University of CincinnatiCincinnati, Ohio  45267-0502
Hawaii Medical Center EastHonolulu, Hawaii  96817
Penn State Milton S Hershey Medical CenterHershey, Pennsylvania  17033
Froedtert and the Medical College of WisconsinMilwaukee, Wisconsin  53226
University of HawaiiHonolulu, Hawaii  96813
Evanston CCOP-NorthShore University HealthSystemEvanston, Illinois  60201
Covenant Medical CenterWaterloo, Iowa  50702
Billings ClinicBillings, Montana  59107-7000
Saint Vincent HospitalGreen Bay, Wisconsin  54301
Saint Mary's HospitalGreen Bay, Wisconsin  54303
The Nebraska Medical CenterOmaha, Nebraska  68198
Norton Health Care Pavilion - DowntownLouisville, Kentucky  40202
Norton Suburban HospitalLouisville, Kentucky  40207
Adams Cancer CenterGettysburg, Pennsylvania  17325
Cherry Tree Cancer CenterHanover, Pennsylvania  17331
The Kirklin Clinic at Acton RoadBirmingham, Alabama  35243
Barnes West County HospitalSaint Louis, Missouri  63141
Christiana Care Health System-Christiana HospitalNewark, Delaware  19718
Arizona Oncology-Deer Valley CenterPhoenix, Arizona  85027