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National Cancer Prevention Month
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PI Interview:
The NRG-CC008 (SOROCk) Study Comparing Two Surgical Procedures for Women with BRCA1 Mutations to Assess Risk Reduction for Ovarian Cancer
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The NRG-CC008/SOROCk trial builds on clinical and translational research that suggests most ovarian cancers begin in the distal fallopian tube. Preliminary data from the SU2C WISP trial has shown that leaving ovaries in place, but removing the tubes helps younger, high-risk (BRCA mutation) women retain hormonal function. However, the SU2C WISP trial was not designed to determine whether or not removing just the tubes – instead of both tubes and ovaries – prevents ovarian cancer. The SOROCk trial is an international clinical trial, designed to convert this preliminary data into clinical action. | |
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PI Interview:
The NRG-CC010 Study for SLN Mapping on Patient-Reported Lower Extremity Limb Dysfunction in Endometrial Cancer
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NRG Oncology recently sat down with NRG-CC010 study co-Principal Investigator (PI), Dr. Edward Tanner, to discuss the phase III trial of assessing the impact of sentinel lymph node (SLN) mapping on patient-reported lower extremity limb dysfunction in patients with endometrial cancer. Watch the video interview or read the written interview below. | |
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National Cancer Prevention Month
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February is National Cancer Prevention Month. As clinical research professionals, those working on FORTE understand how important it is to recognize and highlight cancer prevention clinical trials as part of the cancer prevention discussion. Spread the message that FORTE aims to answer the following question: Should people who had 1 or 2 small, benign polyps removed during colonoscopy have their repeat colonoscopy exam at 10 years or should they have their repeat colonoscopy exams at both 5 and at 10 years? FORTE is needed because the best timing for a repeat colonoscopy is not known. | |
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NRG Study News & New Protocols Under Development
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NRG Activates Phase II Study for AR-Positive Ovarian Granulosa Cell Tumors (NRG-GY033)
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NRG-GY033: A Phase II Study of Androgen Receptor (AR) Inhibition by Darolutamide in Combination with Leuprolide Acetate and Exemestane in Recurrent Adult-Type Ovarian Granulosa Cell Tumor
The NRG-GY033 clinical study activated to patient enrollment in January 2024. This trial will be accruing patients with recurrent ovarian granulosa cell tumors (AGCT) who have progressed on an aromatase inhibitor in a prior line of therapy. Trial participants will receive the drugs darolutamide, leuprolide acetate, and exemestane until disease progresses. The primary objective of this study is to determine the objective response rate of the patients receiving this drug combination.
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Trial Adding Relatlimab to Immunotherapy for Recurrent or Metastatic Nasopharyngeal Cancer Activates (NRG-HN011)
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NRG-HN011 (the “REMAIN” study): A Randomized Phase II Study of Nivolumab versus Nivolumab and BMS-986016 (Relatlimab) as Maintenance Treatment after First-line Treatment with Platinum-Gemcitabine-Nivolumab for Patients with Epstein-Barr Virus-Associated Recurrent/Metastatic Nasopharyngeal Carcinoma (REMAIN)
The NRG-HN011, also known as the “REMAIN” study activated to patient accrual in January 2024. This Phase II trial will accrue patients with recurrent or metastatic nasopharyngeal cancer. Following step 1-2 registration, all trial participants will receive induction treatment with platinum-based chemotherapy, gemcitabine, and nivolumab. Following step 3 registration, trial participants without progressive disease will be stratified by age (over or under 50) and number of sites of disease involvement prior to the induction treatment. Trial participants will then be randomly assigned to receive either maintenance nivolumab or nivolumab with relatlimab (BMS-986016). The primary aim of this study is to determine whether adding relatlimab (BMS-986016) to maintenance nivolumab will show a signal of improved progression-free survival in patients who do not progress following induction treatment.
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New Protocols Under Development
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NRG-CC011 Patient Webpage Activation
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The NRG-CC011 study patient webpage is now LIVE! Learn more about this study that is examining the efficacy of computerized cognitive training compared to the attention control on perceived cognitive impairment post intervention (12 weeks post-randomization) as measured by the FACT-Cog PCI scale.
https://www.nrgoncology.org/CC011
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NRG Health Equity Fellows
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NRG Oncology Selects Health Equity Fellows for 2024 | |
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NRG Oncology (NRG), a National Cancer Institute (NCI) National Clinical Trials Network (NCTN) group, recently announced that they have named two health equity fellows as a part of the organization’s Health Equity Fellowship Program. Fellowship awardees include Dr. Onyinye Balogun and Dr. Stephanie Rieder.
NRG’s Health Equity Fellowship Program was established by Joan Walker, MD, of the University of Oklahoma and an NRG NCI Community Oncology Research Program (NCORP) Principal Investigator, to train selected early-stage investigators in the NRG Oncology system by means of a structured mentorship experience. The program has an emphasis on the recruitment of researchers from underrepresented groups. Selected fellows receive an award of $50,000 for two years with an end result of developing a new research project within NRG Oncology.
Read the press release
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On behalf of the NRG DEI and HD Committees, we commemorate the work, life and the remarkable contributions of our member and colleague, Edith P. Mitchell, MD, MACP, FCCP, FRCP (London). Dr. Mitchell’s many roles: Enterprise Vice President for Cancer Disparities at Jefferson Health’s Sidney Kimmel Cancer Center, Director of the Center to Eliminate Cancer Disparities, and Associate | |
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Director for Diversity Affairs at Jefferson’s Sidney Kimmel Cancer Center, Professor of Medicine and Medical Oncology at Thomas Jefferson University’s Sidney Kimmel Medical College, and honorary membership in American Society for Radiation Oncology, exemplify her exceptional contributions to medicine, cancer care, and the clarity of her focus to end cancer disparities while advancing diversity, equity, and inclusion. | |
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Protocol Support Committee (PSC) Column
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Addressing Diversity in Clinical Trials | |
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Written by Sharon Nicholson Harrell, DDS, MPH, FAGD, FICD, FADI, CDE®, the Chief Diversity Officer of FirstHealth of the Carolinas
I am intrigued by the world of clinical trials. Why, might you ask? As the inaugural Dental Director for FirstHealth of the Carolinas where we have been providing care to underserved children for the past 25 years and as the inaugural Chief Diversity Officer since 2021, clinical trials are not part of my everyday work. However, our integrated healthcare system located in the sandhills of North Carolina is fortunate to house an outstanding Clinical Trials Department in our brand-new Cancer Center who conduct robust, impactful clinical trials. In fact, my New Year’s Resolution is to learn more about the wonderful opportunities they provide to our community. Again, why am I so interested? There are two reasons that immediately come to mind. First of all, I’ve spent the last 25 years of my career providing care to underserved children, and my passion has always been to advocate and increase access in order to level the playing ground for kids who might not have had the same opportunities as others.
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Trevor Johnson Joins the Philadelphia SDMC | |
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The Philadelphia Statistics and Data Management Center (SDMC) office has hired a new Genitourinary (GU) supporting statistician, Trevor Johnson, beginning January 8, 2024. Trevor received his Bachelor’s degree in Chemistry from the University of North Carolina and recently graduated with a Master’s degree in Biostatistics from Duke University. Before joining the NRG Oncology SDMC, Trevor gained experience working with the Duke Clinical Research Institute as a consulting statistician. We are very excited to welcome Trevor Johnson to the SDMC!
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SCT Webinar Series Highlights Methodological Advances in Cancer Clinical Trials | |
On January 24, 2024, NRG Oncology Statisticians Drs. James Dignam, Ted Karrison, and Mei Polley presented at the Society of Clinical Trials (SCT) webinar entitled “Cancer Clinical Trials in the 21st Century: Methodological Advances (The US/NCI Cooperative Groups Experience)”. Organized by Dr. Polley, this session brought together leading methodologists from various NCI/NCTN groups to present ideas and share knowledge on recent methodological advances pertinent to cancer clinical trials grounded by NCTN trial examples. Speakers from other NCI/NCTN groups included Dr. Michael LeBlanc, Group Statistician of SWOG, and Dr. Lindsay Renfro, Associate Group Statistician of COG. | |
Dr. Higgins joins City of Hope Cancer Center Atlanta | |
Our congratulations to Kristin Higgins, MD, for being named senior clinical leader for City of Hope Cancer Center Atlanta, effective January 23, 2024. Dr. Higgins is a member of the NRG Oncology Board of Directors, Lung Cancer Core Committee, Protocol Operations Management Committee, and Communications Committee. She also co-chairs the NRG Social Media Workshops held during the NRG Oncology Semi-annual meetings. Read the announcement. | |
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Register TODAY for #NRG2024 in Orlando | |
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The NRG Winter Meeting will be held in-person only at the World Center Marriott in Orlando, FL from Thursday, February 15, 2024 - Saturday, February 17, 2024 with select virtual session offerings.
Please visit our meeting webpage for the agenda and more information.
Register here
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