Page 11 - Delaware Medical Journal - May/June 2019

NRG-BN003: Phase III Trial of Observation Versus Irradiation for a Gross Totally Resected Grade II Meningioma The objectives of the trial are:
Primary Objective:
The primary endpoint is progression-free survival (PFS). The principal objective is to determine the extent of clinical benefit of the addition of adjuvant
radiotherapy (RT) to gross total resection (GTR) for patients with newly diagnosed World Health Organization (WHO) grade II meningioma.
Secondary Objective:
• Overall survival (OS);
• Disease-specific survival (DSS);
• Toxicity (grade 3+, exclusive of expected alopecia);
• Neurocognitive function (NCF);
• Outcomes and Patient-Reported Outcomes (PRO) measurements;
• Adherence to protocol-specific target and normal tissue parameters;
• Concordance measurements of central versus parent-institution pathology; • Assessment of pHH3 mitotic index and its correlation with PFS and OS;
• Tissue and specimen collection for future translational research.
We hypothesize that increased rate of progression in the observation arm will be associated with greater NCF/Patient-Reported Outcome (PRO) deterioration. We anticipate no increase in 3-year toxicity, a high-rate adherence to protocol RT guidelines (96% per protocol or acceptable variation in RTOG 0539), high rates of pathology concordance (88% for WHO grade II with RTOG 0539), a high rate of tissue collection for translational research (90% with RTOG 0539), and improved identification of mitotic figures with PFS correlates using pHH3.
Eligibility:
Central pathology review must occur between Steps 1 and 2 of registration.
PRIOR TO STEP 1 REGISTRATION
• The patient must have a newly diagnosed unifocal intracranial meningioma, gross totally resected, and histologically confirmed as WHO grade II based upon pathology findings at the enrolling institution. WHO grade will be assigned according to WHO 2016 criteria.
• Gross total resection (GTR) will be interpreted as modified Simpson grade 1-3 (see table below) without gross residual dural-based or extradural tumor. GTR must be confirmed both by modified Simpson grade and by post-operative MRI findings.
• Step 1 registration must occur within 180 days of the initial surgery.
• GTR must be confirmed on post-operative imaging following the most recent surgery; submission of both pre-operative and post-operative MRIs is required for patients.
PRIOR TO STEP 2 REGISTRATION
• Histologically confirmed diagnosis of WHO grade II meningioma confirmed by central pathology review prior to Step 2 registration
• Women ≥18 years old, history/physical examination, including neurologic examination and post-operative Zubrod Performance Status 0-1 all within 60 days prior to Step 2 registration
• If the patient is a woman of childbearing potential, a serum pregnancy test, obtained within 14 days prior to Step 2 registration, must be negative, and, if randomized to receive radiation therapy, the woman must agree to use contraception.
Treatment:
Arm 1: Observation
Arm 2: Radiation Therapy (IMRT or Protons) 59.4 Gy (1.8 Gy x 33)
For information regarding this clinical trial or if you would like to have the list of open protocols emailed to you, please call the Cancer Research Office at (302) 623-4450 or email akee@christianacare.org.
CANCER CLINICAL TRIAL
Del Med J | May/June 2019 | Vol. 91 | No. 3 107