NCI Community Oncology Research Program - Protocol Summary
NRG-BN003 - "PHASE III TRIAL OF OBSERVATION VERSUS IRRADIATION FOR A GROSS TOTALLY RESECTED GRADE II MENINGIOMA"
The summary below serves as a brief review of the treatment plan and eligibility for the protocol.
This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
Please contact NCORP-KC for complete protocol information.
Brain/CNS Clinical Trial
CANCER TYPE: Meningioma
RESEARCH BASE: NRG
NCT NUMBER: NCT03180268
HIPPA FORM: DOWNLOAD HIPPA FORM
Consent Form: VIEW CONSENT FORM
Meningioma, newly diagnosed, gross totally resected, WHO grade II, observation vs. RT (IMRT or protons).
- Submission of tumor tissue is required for all patients. Investigators should check with their site Pathology department regarding release of biospecimens before approaching patients about participation in the trial.
- Central pathology review must occur between Steps 1 and 2 of registration. Once appropriate pathology specimens are received, central pathology review will occur within 15 days, and must confirm WHO grade II meningioma before the patient can proceed to Step 2 registration and randomization.
- Sites are required to submit ALL H&E slides from each paraffin block for each case and one representative paraffin block with tumor. The H&Es do not have to be diagnostic slides, they can be duplicate cut slides. The H&E slide that matches the block being submitted must remain at the bank with the block.
- For IMRT: The institution must be credentialed for IMRT planning and delivery by IROC-Houston (http://irochouston.mdanderson.org) using an anthropomorphic H&N QA phantom. Measured dose and dose distributions will be compared to the institution’s calculated planned dose distribution from the institution’s planning system. An IROC Houston credentialed algorithm must be used.
- For Protons: The institution must have passed the IROC Houston approval process as outlined in the NCI guidelines for treating clinical trial patients with SOBP and/or PBS.
- TRIAD is the image exchange application used by the NRG. TRIAD provides sites participating in NRG clinical trials a secure method to transmit DICOM RT and other objects. TRIAD anonymizes and validates the images as they are transferred.
- Institutions must meet certification requirements for administering neurocognitive assessments. Upon review and successful completion of the Neurocognitive Certification, Jeffrey S. Wefel, PhD, the Neuropsychology Co-Chair, will notify both the certified examiner and NRG Headquarters that the examiner has successfully completed this requirement.
- See protocol-specific material on CTSU website for certification requirements. Go to the CTSU web site and use your username and password to access the link entitled, “Neurocognitive Training Procedure Letter”. This letter will provide you with the web address and study specific password for the training video as well as the Training Video Post Test.
Radiation therapy 59.40 Gy, given in 33 treatments
Must begin within 60 days after step 1 registration OR 30 days after step 2 registration, whichever is greater
- 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 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. This will provide sufficient time for post-operative imaging confirmation of resection extent after resolution of operative changes. Moreover, it will permit additional surgery if needed to achieve a GTR. Within this 180 day interval, a second surgery is permitted in order to achieve GTR, but even with a second surgery, Step 1 registration must occur within 180 days of the initial resection.
- For step 1 registration the operating neurosurgeon must provide the modified Simpson grade.
- GTR must be confirmed on post-operative imaging following the most recent surgery. For protocol enrollment, the assessment of GTR will be made at each site. However, submission of both pre-operative and post-operative MRIs is required for patients. If a second surgery is performed, submission of post-operative MRI is required and pre-operative MRI is required only if obtained. All sequences obtained in the pre- and post-operative MR imaging are to be submitted to NRG Oncology for study registration. Imaging subsequent to enrollment must include pre and post gadolinium contrast-enhanced three-dimensional spoiled gradient (SPGR), magnetization-prepared rapid gradient echo (MP-RAGE), or turbo field echo (TFE) MRI scan and an axial T2 FLAIR sequence. To yield acceptable image quality, the gadolinium contrast-enhanced three-dimensional SPGR, MP-RAGE, or TFE axial MRI scan should use the smallest possible axial slice thickness not exceeding 1.5 mm. The post-operative MRI must be completed within sufficient time to permit Step 1 registration within 180 days of the initial resection. These same conditions apply in the setting of a second surgical procedure, although if a second surgery is completed, Step 1 registration must still occur with 180 days of initial surgery (see Section 3.2.3). CT imaging is not required, but may be obtained if desired clinically, for instance to assess calcifications or hyperostosis.
NOTE: Central pathology review must occur between Steps 1 and 2 of registration. Once appropriate pathology specimens are received, central pathology review will occur within 15 days, and must confirm WHO grade II meningioma before the patient can proceed to Step 2 registration and randomization. See Section 10 for details of central pathology review.
- Histologically confirmed diagnosis of WHO grade II meningioma confirmed by central pathology review prior to Step 2 registration
- Age ≥ 18;
- History/physical examination, including neurologic examination within 60 days prior to Step 2 registration
- Post-operative Zubrod Performance Status 0-1 within 60 days prior to Step 2 registration;
- If the patient is a woman is 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 as defined in Section 3.1.2.
- No Optic nerve sheath meningioma, spinal or other extracranial meningioma, multiple meningiomas, hemangiopericytoma;
- No Definitive evidence of metastatic meningioma (metastasis, although rare, can occur and is exclusionary);
- No Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (carcinoma in situ of the breast, oral cavity, cervix, melanoma in situ, or other non-invasive malignancies are permissible);
- No Previous radiotherapy to the scalp, cranium, brain, or skull base and radiation-induced meningiomas;
- No Major medical illnesses or psychiatric impairments, which in the investigators opinion, will prevent administration or completion of the protocol therapy and/or preclude informed consent.