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NRG Oncology NCORP Lisa Kachnic MD, FASTRO Associate Chair
NRG Oncology Semi-annual Meeting New Investigators Meeting January 10, 2020
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What is Cancer Control Research?
Cancer control research is the conduct of basic and applied investigation in the behavioral, social and population sciences to create or enhance interventions that, independently or in combination with biomedical approaches, reduce cancer risk, incidence, morbidity and mortality, and improve quality of life. Cancercontrol.cancer.gov accessed
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NCI Community Oncology Research Program (NCORP) Network
The NCI NCORP is a national network that brings cancer clinical trials and care delivery studies to people in their own communities. Their focus areas include: Cancer Control and Prevention Symptom Management Screening Post-Treatment Surveillance Quality-of-Life Studies Embedded in Treatment Trials Cancer Care Delivery Cancer Disparities
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NCI NCORP Network Structure
The NCORP is housed in the NCI Division of Cancer Prevention, with collaboration by the NCI Division of Cancer Control and Population Sciences, NCI Division of Cancer Treatment and Diagnosis and NCI Center to Reduce Cancer Health Disparities NCORP is comprised of 7 Research Bases and 46 Community Sites, 14 of which are designated as Minority/Underserved (MU) Community Sites NCORP MU Community Sites have a patient population comprised of at least 30% racial/ethnic minorities or rural residents The NCORP Community Sites accrue participants to NCI-approved cancer clinical trials The sites are consortia of researchers, public hospitals, physician practices, academic medical centers, and other groups that provide healthcare services in communities across the U.S
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Overall NCI NCORP Accrual by Year 8/1/14 – 10/31/18
Total: 26,954 It is important to note that 30% - 35% of the patients enrolled on NCTN clinical trials, including precision medicine studies, are from NCORP sites
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NRG Oncology NCORP Structure
NCORP Operations Committee Ca Prevention and Control Research (CPCR) Co-Chairs: L Kachnic, D Levine Vice Chairs: D Barton, J Bauman - Neurocognitive Function Gender-specific Symptom Mgmt Behavioral Interventions Dose Alterations Ca Risk Reduction Health Disparities Research (HDR) Chair: K Yeager Vice Chair: C Hughes Racial/Ethnic Minorities Elderly Rural Populations Patient Centered Outcomes Research (PCOR) Chair: B. Movsas/ Vice Chairs L. Wenzel, P Ganz - PROs tx trials - Consult on PROs in CCC, CPC, CCD, HDC trials NRG NCORP Finance Committee
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NRG NCORP Core Grant Aims and Priorities
Four symptomatic management themes: neurotoxicity cardiotoxicity lymphedema inflammation Cancer prevention, survivorship and palliative interventions Cancer care delivery Cancer disparity research, in collaboration with our Health Disparities Research (HDR) Program
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NRG NCORP Changing Standard of Care
Major changes over this past grant period: R0614: Memantine during whole brain RT reduces neurocognitive deterioration R0933: Hippocampal avoidance during whole brain RT leads to HVLT preservation R1203: IMRT reduces bowel toxicities (over 3D RT) from the patient perspective in postop GYN cancers
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Sig. neurocog. differences favoring memantine arm for:
Brown et al. Memantine for the prevention of cognitive dysfunction in patients receiving whole-brain radiotherapy (RTOG 0614): A randomized, double-blind, placebo-controlled trial. Neuro Oncol. 2013;15(10): Gondi et al. Preservation of memory with conformal avoidance of the hippocampal neural stem-cell compartment during whole-brain radiotherapy for brain metastases (RTOG 0933): A phase II multi-institutional trial. J Clin Oncol. 2014;32(34): Cumulative incidence of cognitive function sig. improved In Memantine arm. Hopkins Verbal Learning Test (HVLT) scores sig. improved over historical controls for 50 pts alive at 6 mos. Sig. neurocog. differences favoring memantine arm for: COWA scores at 8 (P = .008) and 16 weeks (P = .0041) TMT-A and MMSE at 24 weeks (P = and .0038, respectively), HA-WBRT (IMRT) for pts with brain mets associated with sig. prevention of HVLT-R DR decline, compared with prespecified historical controls of WBRT without HA FACT-BR emotional well being improved over time (P = .042). Other FACT-BR domains and ADL scores remained stable. Only 4.5% experienced progression in the hippocampal avoidance area vs, historic 8.6% The significantly positive findings for both of these intervention were combined/informed the current generations of trials.
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Baseline neurocognitive assessment: HVLT-R, TMT, COWA
CLOSED NRG-CC001: A Randomized Phase III Trial of Memantine and Whole-brain Radiotherapy with or without Hippocampal Avoidance in Patients with Brain Metastases SCHEMA STEP 1 REGISTRATION STRATIFICATION RPA Class: 1. Class I 2. Class II Prior therapy: 1. None 2. Radiosurgery or surgical resection* STEP 2 REGISTRATION Baseline neurocognitive assessment: HVLT-R, TMT, COWA RANDOMIZATION Arm 1 WBRT 30 Gy/10 fractions + Memantine** Arm 2 WBRT with Hippocampal Avoidance using IMRT 30 Gy/10 fractions + Memantine**
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Small Cell Lung Ca Stage Concomitant Memantine
OPEN NRG-CC003: Phase IIR/III Trial Prophylactic Cranial Irradiation with or without Hippocampal Avoidance for Small Cell Lung Cancer Stratify Randomi ze PCI 25Gy/10 Small Cell Lung Ca Stage Concomitant Memantine HA-PCI 25Gy/10 Basic Eligibility: Small cell lung cancer; PR or CR to chemo; ECOG PS≤70; MRI scan Sample Size: Phase IIR: 172 patients Phase III: 304 patients Primary Endpoints: Phase IIR—Intracranial relapse rate at 12 months Phase III—HVLT-R delayed recall deterioration at 6 months Statistical Design: Phase IIR: Non-inferiority margin of >20% difference; 164 analyzable pts Phase III: 29% with PCI vs. 14.5% with HA-PCI; 198 analyzable pts
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Brain Mets from Small Cell Lung Ca
Developing NRG-CC1974: Phase III Trial Stereotactic Radiosurgery versus Hippocampal-Avoidant Whole-Brain Radiotherapy for Brain Metastases from Small Cell Lung Cancer Basic Eligibility: Small cell lung cancer; ≤10 brain mets≤3cm; total vol 30cc; KPS≥70 Randomi ze Stratify SRS alone Brain Mets from Small Cell Lung Ca DS-GPA Exposure to NCF Testing* HA-WBRT Gy/10 *Pts enrolled on SWOG trial will have been exposed to NCF Testing Sample Size: 200 patients Primary endpt: Time to cognitive failure--HVLT-R, COWA, and TMT A and B Basic Statistical Design: Cognitive fxn failure 58.8% at 6 mos with HA-WBRT+mem vs. 41.8% at 6 mos with SRS. 150 analyzable pts
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Completed NRG NCORP Trials
Study Disease Date Closed G0273 Chemo tolerance in elderly patient 6/4/2014 G0244 Lymphedema incidence, risk factor and impact 11/17/2014 B-43 RT vs. RT+Trast 12/8/2014 R1203 3D vs. IMRT for pelvic RT 8/27/2015 NRG-CC002 Elderly post-op outcomes 11/2/2015 NRG-CC001 Memantine + WBRT w/ or w/out HA in pts w/ Brain Mets 3/12/2018 G225 Diet and Exercise to Prevent Ovarian Cancer Recurrence 8/24/2018 G237 CA-IX, p16, PHV for Dx of AGUS in Cervical Cancer 8/2/2019 The completed NRG CPC trials are listed; it is important to note that NCORP sites are our leading accruers for treatment and CPC trials.
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Ongoing NRG NCORP Trials **accrual as of December 31, 2019
Study No Disease Site Description Date Activated Target Accrual Total Accrual NCORP Accrual (%) Expected Closure GOG 278 Cervix Physical fx & QOL before/after non-radical surgery 10/1/12 220 199 <1% Aug 2020 NRG CC003 Lung Seamless Ph II/III PCI vs. PCI with hippocampal sparing for cognitive fx 12/7/15 172 (II) 302 (III) 176 of 172 (II) 266 of 302 (III) 30% Phase II complete: Re-opened to Phase III accrual Jan 2019 CC004 Breast, GYN Ph II Bupropion trial testing 150 vs 300 mg to improve sexual desire more than placebo 5/31/17 234 219 100% March 2020 CCD007 Prostate Survivorship care plan for prostate ca survivors on ADT to increase blood glucose and cholesterol checks in yr 2 after starting ADT & lower CVD risk 03/27/19 504 21 0% October 2021
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Developing NRG NCORP Trials
Study No Disease Comments NRG-CC005 Forte – Five or Ten Year Colonoscopy for 1-2 Non-advanced Adenomatous Polyps Protocol submitted to DCP NRG-CC008 A Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-oophorectomy to Reduce the Risk of Ovarian Cancer Among BRCA1 Carriers [SOROC] Protocol pending CIRB and DCP final approval NRG-CC1974 SRS vs. HA-WBRT for 10 or fewer Brain Metastases from Small Cell Lung Cancer Concept submitted to DCP FORTE if approved, will provide cancer control credits for entry plus additional credits for each year of follow-up. It should be an excellent way for NCORP sites to meet their cancer control requirements. N= The primary endpoint for the trial is the incidence of CRC.
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NRG NCORP Concept Development Guidelines
All new NCORP concepts must be reviewed and vetted by the appropriate Cancer Prevention and Control, Cancer Care Delivery Research or Health Disparities committees High priority concepts will then be presented by the committee co-chairs to the NCORP PIs at monthly strategy meetings Those felt to be most meritorious are invited to move on to the NCORP formal concept review process
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NRG NCORP Concept Review Process
Concepts considered for NCORP formal concept review have been presented and supported by the relevant NCORP committee; NRG disease site committee and seen by NRG statistician to comment on potential sample size Concepts are distributed and assigned to appropriate reviewers for content, PROs, TRP, Stats, pt advocate, community feasibility and will obtain written comments At NCORP steering committee face-to-face meeting (or conference call), PI may introduce study in a few sentences, no slides permitted. Reviewers will present comments and recommendations. Call for concepts will be sent to all NCORP Committees with submission deadline Concepts meeting the requirements above are submitted to on the NCORP concept submission form Approval Revise and Resubmit Disapproval If approved, present to NRG Research Strategy Committee/CPAC, upon approval submit to NCI submission Revise proceed through re-review as above End
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How to Become a Member CPC and CCDR Committees are soliciting new members beginning January 2020 Watch for NRG broadcast announcement after the meeting!
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Other Opportunities Seed Grant Pipeline & ‘Buddies’
Seed grant announcement mid-February 2020 Will Incorporate New Investigator Mentee on Protocols Travel Grants Call for applications 8-10 weeks prior to each semiannual meeting Secondary Analyses
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Questions?
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