Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas

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1 RTOG 0539 Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas Volume 4, Issue 2 September 2012 I N T HIS I SSUE Thoughts From the Chair Thoughts From the Chair C. Leland Rogers, MD, FACRO Principal Investigator Notes for Sites Final Enrollment We have now, in timely fashion, completed accrual to RTOG This is, as best we can tell, the first meningioma study to reach its accrual goals within a cooperative group. Research on many fronts will ultimately spring from this well, but there is considerable room for gratitude before these varying projects come to fruition. First and foremost, permit a strong expression of appreciation to everyone who opened this study at their institution and enrolled their patients. Clearly no cooperative group study can succeed without these critical steps. Indeed this is precisely what "cooperative" means: concerted and collaborative. RTOG is funded by NCI Grants U10CA21661, U10CA37422 and U24CA RTOG is administered by the American College of Radiology As this very newsletter attests, RTOG 0539 was selected by CTEP for an ACTNOW (Accelerating Clinical Trials of Novel Oncologic pathways) grant. These funds were used to enhance remuneration to enrolling institutions. Kudos to the NCI for viewing our study of meningiomas as novel and promising. This funding, no doubt, encouraged accrual and helped considerably with the successful and timely attainment of our accrual goals. Thanks to the many at RTOG, both employees and volunteers, who made this possible. Several years of machination were required to devise a study that would be acceptable to all involved. These varying study iterations passed through the Brain Tumor Steering and Neurosurgery Subcommittees, the broader Brain Tumor Committee, Research Strategy, and ultimately the NCI. Considerable effort was expended by Kathryn Okrent, Denise Manfredi, and Meihua Wang at RTOG and by Bill Straube at the Image Therapy Center (ITC) -- to name only a few. On the volunteer and physician side, the enduring efforts and insights of Minesh Mehta, Mike Vogelbaum, David Brachman, and Wally Curran cannot be overestimated. At the NCI, the foresight and assistance of Dr. Bhadrasain Vikram were indispensable. Continued on next page RTOG

2 Continued from previous page C ONTACTS Study Chairs Principal Investigator C. Leland Rogers, MD, FACRO leland@gammawest.com Neurosurgery Michael A. Vogelbaum, MD, PhD vogelbm@ccf.org Neuropathology Arie Perry, MD aperry@wustl.edu Neuroradiology Bruce Dean, MD bdean@sniweb.net Translational Research Adam P. Dicker, MD, PhD adam.dicker@mail.tju.edu Kevin Camphausen, MD camphauk@mail.nih.gov Neuro-Oncology Lynn Ashby, MD lashby@chw.edu Image-Guided Radiation Therapy Christina I. Tsien, MD ctsien@umich.edu Regarding those who were critical as co-investigators, much gratitude to Arie Perry who, in rapid fashion, centrally reviewed pathology in each case. His work lends the study considerable merit and renders WHO grading, which was pivotal in the study's design, credible. The era of this trial has seen vast changes in meningioma grading. At study inception, only about 5% of meningiomas were graded as atypical (WHO grade II), whereas this has increased to approximately 25% at present. It would not have been possible to tame this horse without someone of his calibre holding the reigns. David Brachman, Lynn Ashby, and Terri Thomas of Arizona Oncology Services (AOS) and the Barrow Neurological Institute (BNI) in Phoenix have played a central role in many RTOG brain tumor trials and enrolled nearly 20% of the patients on RTOG Bruce Dean, also at BNI, our neuroradiology co-chair, centrally reviewed a very large number of imaging studies. Such central review will strengthen study results and will provide a template for future work. Kevin Camphausen and Adam Dicker served as translational research co-chairs and are actively seeking immunohistochemical and molecular markers of recurrence from the patients enrolled in this trial. Helen Shih and Hsiao-Ming Lu at Massachusetts General Hospital played key roles in expanding the trial for the use of protons. We have, of course, left many unheralded. The efforts of a large number of unsung heroes infuse every successful cooperative group trial, and much work yet awaits the efforts of many dedicated investigators. Please accept our kudos and deepest expressions of gratitude. Medical Physics James Galvin, DSc james.galvin@mail.tju.edu Proton Therapy Physics Hsiao-Ming Lu, PhD hmlu@partners.org Proton Radiation Oncology Helen A. Shih, MD hshih@partners.org RTOG

3 C ONTACTS (CONT D ) RTOG Headquarters Protocol Development Kathryn Okrent, MA kokrent@acr.org Radiation Therapy Quality Assurance Denise Manfredi, AS, RT(T) dmanfredi@acr.org Data Management Sandrine Geinoz, PhD sgeinoz@acr.org Juliet Obropta, BSN jobropta@acr.org Notes for Sites Calendar Due Dates and Follow-Up Forms Please note that calendar due dates are place holders, not exact dates. Sites should always submit follow-up forms according to the timelines provided in Section 12.0 of the protocol and should use the next available F1 due point on the calendar to submit data. IRB Reviews Please continue to submit annual reviews to your IRB until RTOG terminates this study. Sites that feel they meet the criteria for early IRB closure may submit the Request for Study Closure with Site IRB form. This form should be submitted to RTOG prior to closure with your local IRB. The form and further instructions are located on the RTOG website: Final Enrollment Numbers Active Sites 190 Pts Registered to Step Not registered to Step 2 66 Due to patient refusal 18 Due to pathology issues 9 Due to eligibility issues 7 Due to timeline issues 6 Due to physician preference 4 Due to RX started prior to pathology 2 Due to disease progression 1 Due to other complicating diseases 1 Due to other reasons 8 Due to study closure prior to 2 nd registration 10 Pts Registered to Step 2 Group I 65 Group II 56 Group III 57 Closure Dates Group I 9/29/2010 Group II 5/12/2011 Group III 8/24/2012 RTOG

4 Total Accrual RTOG

5 Final thank you!!! to all enrolling institutions: Institution Enrollment Arizona Oncology Services Foundation 43 McMaster Univ, Juravinski Can Ctr, Hamilton Health Sciences 15 University of California San Francisco 11 University of Utah Health Science Center 11 Medical University of South Carolina 11 University Hospitals of Cleveland 8 University of Maryland Medical Systems 7 Medical College of Wisconsin 7 Cleveland Clinic Foundation 6 Norton Cancer Institute 6 Virginia Commonwealth University 6 Carolinas Medical Center/Levine Cancer Institute 6 Montefiore Medical Center 5 St. Lukes Hospital 5 Washington University 5 Dartmouth Hitchcock Medical Center 4 University of Michigan Medical Center 4 Intermountain Medical Center 4 Waukesha Memorial Hospital 4 McGill University 4 University of Oklahoma Health Sciences Center 4 North Shore University Hospital CCOP 4 Kansas City CCOP 4 Ohio State University Medical Center 3 London Regional Cancer Program 3 Mayo Clinic 3 University of Colorado Denver 3 Cross Cancer Institute 3 Centre Hospitalier de l`université de Montréal-Notre Da 3 Univ of Kansas Comprehensive Cancer Center 3 University of Washington Medical Center 2 Emory University 2 Baystate Health-D'Amour 2 Northwestern Memorial Hospital 2 The Ottawa Hospital Regional Cancer Centre 2 Cape Radiation Oncology 2 Maine Medical Center 2 University of Texas-MD Anderson Cancer Center 2 University of Wisconsin Hospital 2 Yale University 2 Long Island Jewish Hospital 2 Continued on next page RTOG

6 Continued from previous page Mayo Clinic in Arizona 1 Dixie Medical Cancer Center 1 Akron City Hospital 1 Tel-Aviv Medical Center 1 City of Hope Medical Center 1 Indiana University Medical Center 1 Billings Clinic Cancer Center 1 University of Nebraska Medical Center 1 Thomas Jefferson University Hospital 1 Memorial Medical Center 1 Henry Ford Hospital 1 Methodist Cancer Center 1 Gunderson Clinic 1 H. Lee Moffitt Cancer Center & Research Institute 1 The University of Arizona Medical Center - University Campus 1 Penn State University and The Milton S. Hershey Medical Ctr 1 Kalamazoo CCOP-West Michigan Cancer Center 1 RTOG