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Honoring a Legacy: Dr. Worta McCaskill-Stevens
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In November 2023, the cancer research community lost an extraordinary and irreplaceable leader. Dr. Worta McCaskill-Stevens was a founding director of the National Cancer Institute (NCI) Community Oncology Research Program (NCORP) when the program was established in 2014 and served as the program’s director until shortly before her passing. She was a tireless advocate for efforts mitigating cancer disparities. She served as a respected mentor to many and evidenced a passion for physician education and advocacy for underserved communities. | |
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NRG PCOR Educational Session at #NRG2024 in Orlando
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The Patient Centered Outcomes Research (PCOR) Committee Chairs are pleased to announce that they will be offering an educational session at the Winter 2024 NRG Meeting in February in Orlando for NRG investigators interested in learning about the basics of how to design patient reported outcomes (PROs) components for future NRG trials.
This educational session is designed to broaden the knowledge of PROs among NRG investigators and is especially appropriate for investigators who might want to help design future trials and to serve as PRO co-chairs. Some of the topics that will be covered in this session will include how to select appropriate PRO measures for a trial, how to design hypothesis-testing PRO components for a trial, the NCI review and approval process, and basic statistical considerations.
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NRG Study News & New Protocols Under Development
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The “High Five Trial” for High-Risk Prostate Cancer Activates (NRG-GU013)
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NRG-GU013 (High Five Trial): The Phase III ‘High Five Trial’ Five Fraction Radiation for High-Risk Prostate Cancer
The NRG-GU013, also known as the “High Five Trial” activated to high-risk prostate cancer patient enrollment in November 2023. Trial participants will be stratified by pelvic lymph node treatment, length of androgen deprivation therapy (ADT), treatment with second generation anti-androgen and treatment with a microboost. After stratification, patients will be randomly assigned to either Group 1 where they will receive stereotactic body radiation therapy (SBRT) in 5 fractions or Group 2 where they will receive radiation in conventional or moderate hypofractionation in 20-45 fractions. The primary objective of the High Five Trial is to determine if SBRT does not have worse metastasis-free survival for this patient population when compared to the conventional or moderate hypofractionation regimen.
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NRG-BR009, the "OFSET" Study, Video Interview
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Drs. Terry Mamounas and Shannon Puhalla discuss the NRG-BR009 OFSET Study which is testing the addition of chemotherapy to the usual treatment of ovarian function suppression plus hormonal therapy in premenopausal ER-positive/HER2-negative breast cancer patients who are at high risk of cancer returning.
Watch the full interview
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New Protocols Under Development
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PRESS RELEASE: NRG-BR008 "HERO" Study Seeks to Optimize use of Radiotherapy in Patients with Early-Stage, Low-Risk, HER2-Positive Breast Cancer
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Opened to patient enrollment earlier this year, NRG Oncology’s NRG-BR008 clinical trial (The “HERO” Study) is a large, randomized study that is comparing the recurrence-free interval (RFI) among patients with early-stage, low risk, HER2-positive breast cancer who undergo breast conserving surgery and receive HER2-directed therapy and are randomized to receive adjuvant breast radiotherapy per the current standard of care or forego breast radiotherapy.
Given that radiotherapy is known to roughly halve local recurrence rates following lumpectomy in many settings, it is hypothesized that local recurrences may increase modestly with the omission of radiotherapy in the proposed populations (pT1N0 for those receiving adjuvant chemotherapy and, clinically T ≤3 cm N0 at baseline and ypT0N0 after neoadjuvant therapy for those receiving neoadjuvant chemotherapy).
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Best Wishes to NRG Oncology SDMC Statistician, Joseph Rodgers | |
After 7 years with the Philadelphia office, Joe Rodgers departed from the NRG Oncology Statistics and Data Management Center (SDMC) on December 1st, 2023. During his time with NRG, Joe provided statistical support to the Genitourinary (GU) Committee, including statistical programming and analysis for GU cancer trials. His work also extended to translational research projects in prostate and bladder cancer. We would like to convey our appreciation for Joe’s contributions to the SDMC and wish him much luck in his future endeavors. | |
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Congratulations, Jim Dignam!
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Jim Dignam was invited to join the Biostatistics Editorial Board for the Journal of Clinical Oncology, the flagship journal of the American Society for Clinical Oncology and a frequent venue for NRG study results. Chen Hu currently serves as a Board member for this journal.
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Protocol Support Committee (PSC) Column
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Managing Data and Query Expectation in NCI Research Studies | |
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In order to provide continuing study key timepoints to clinical trial sponsors, participant data should be entered within protocol standards. It is essential that the generated queries complete the communication for accurate reporting.
Data quality and query performance feedback are provided via institutional performance evaluations in data collection, data management, and overall data quality.
Member institutions and affiliate sites are required to manage the completion of data timeliness and query resolution.
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NRG Templates - NRG Presentations
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New NRG Oncology Slide Templates Now Available
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NRG Oncology Research Presented at #SABCS23 | |
NRG Oncology investigators recently attended the 2023 San Antonio Breast Cancer Symposium where several posters were presented for ongoing clinical trials, including NRG-BR007 DEBRA Trial, NRG-BR008 HERO Trial, and NRG-BR009 OFSET Trial. During the General Session 2, Eleftherios Mamounas, MD, from the Orlando Health Cancer Institute and chair of the NRG Oncology Breast Cancer Committee, presented the primary outcomes of the NRG Oncology/NSABP B-51/RTOG 1304 study. This trial enrolled over 1,600 patients who were diagnosed with lymph-node positive, nonmetastatic breast cancer and whose lymph nodes were found to be cancer-free after neoadjuvant chemotherapy and who had undergone either mastectomy or breast-conserving surgery. The findings suggest that downstaging involved axillary nodes with neoadjuvant chemotherapy can optimize adjuvant radiotherapy use without adversely affecting oncologic outcomes. | |
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Dr. Daniel Spratt receives Distinguished Professor honor at University Hospitals | |
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Our congratulations to Daniel Spratt, MD, for being recognized as a Distinguished Professor at University Hospitals’ 6th annual ceremony honoring physicians and surgeons, nominated for providing exceptional care to their patients.
(Photo: @DrSpratticus/TwitterX)
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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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