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December 23, 2024

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NRG Oncology Winter Meeting Registration is Now Open!

Join us in Phoenix, AZ for the NRG2025 Winter Meeting. The meeting will be held in-person, January 16-18, 2025, with select virtual sessions being held January 6-14, 2025. Register soon to avoid the late registration fee!

More information | Agenda | Register

Winter 2025 Symposium – Designing and Implementing Pragmatic Clinical Trials in Oncology

A new type of trial design is coming to NRG Oncology. This important symposium will be held in-person in Phoenix on Thursday, January 16, 2025 from 8am – 12pm MT. There will also be a virtual option. The symposium will highlight the value of pragmatic clinical trials across oncology and include examples of trials in lung, breast, and gynecologic cancers.

More information  | Agenda | Register

 

NRG NCORP Bootcamp – January 16, 2025

NRG NCORP will host a Bootcamp on January 16, 2025, 8-10am MT during the NRG Oncology Winter Meeting in Phoenix. This session will provide an overview of the NRG Oncology NCORP Research Base with a specific focus on developing and designing an NCORP concept. Committee chairs will highlight priorities in Cancer Prevention and Control (CPC), Cancer Care Delivery Research (CCDR), and Health Disparities Research (HDR). Dr. Pugh will discuss statistical design considerations and Dr. Crane will discuss how to run an R01 utilizing the NCORP process. Flyer | Register

 

NRG Oncology Protocol Support Committee – Educational Sessions

Please be sure to sign up to attend the PSC Nurse/CRA Sessions being held during the NRG Oncology Winter Meeting in Phoenix. The Protocol Support Committee (PSC) will offer Introduction to Clinical Trials: Principles of NRG Oncology Clinical Trial Management for Nurse/CRAs on Thursday, January 16. Morning presentations and afternoon discussion sessions will be presented in-person and virtually. The Continuing Education Session for Nurse/CRAs on Friday, January 17 will be held virtually and in-person and are for both seasoned and new research staff. Please refer to the posted agendas (login required) and flyers for more details about the PSC programing offered during #NRG2025.


Communications & Digital Engagement Workshop (formerly Social Media Workshop)

The NRG Oncology Communications Committee is pleased to announce our Communications & Digital Engagement (CDE) Workshop (formerly Social Media Workshop) as part of #NRG2025. The workshop, being held as a virtual session, is scheduled for Monday, January 13, 2025, 1-2pm ET/11am-12pm MT. Drs. Kristin Higgins and Miriam Knoll, members of the NRG Oncology Communications Committee, are the session chairs. The speakers include Dr. Eli Sapir and Dr. Orit Gutfeld, co-chairs of the International Radiation Oncology Conference; Dr. Lauren Henke from University Hospitals/Case Western University will give an update on The NRG Oncology Podcast and Dr. Higgins will present an update on the NRG Oncology PI Toolkit. Register here

ACTIVATIONS

CANCER PREVENTION & CONTROL

NRG-CC013: A Randomized, Masked, Placebo Controlled, Phase II Trial of Concurrent Chemoradiation With BMX-001 in Patients With Head and Neck Squamous Cell Carcinoma Receiving Concurrent Chemoradiation, Activation Date and Temporary Closure: December 16, 2024 (posted on CTSU)

 

HEAD & NECK

NRG-HN014: Randomized Phase III Trial of Neoadjuvant Immunotherapy With Response-Adapted Treatment Versus Standard-of-Care Treatment for Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma, Activation Date: December 20, 2024 2024 (posted on CTSU)

 

OTHER PROTOCOL NOTICES

1. ALL DISEASE SITES

NRG-GY022: Reminder: Actively Recruiting MALE Patients only Read More

 

2. BIOSPECIMEN BANKS

Printing Biospecimen Transmittal PDFs from Rave

Please note an effort is underway to clarify how to obtain a Biospecimen Transmittal PDF for submission to the NRG Oncology Biospecimen Bank. Read More


3. BRAIN

NRG-BN011: NYU Langone will close at 3pm on December 24th & December 31st and will be closed all day on December 25th & January 1st. Please plan tissue shipments accordingly.

 

NRG-BN011: Gleostine (Lomustine) Shipment Schedule December 20, 2024 – January 6, 2025.

Participating sites ordering Gleostine (Lomustine) for new and existing study patients enrolled in NRG-BN011, please be advised of the following schedule beginning December 20, 2024, through January 6, 2025.

 

Transition Pharmacy, NextSource Pharmaceuticals pharmacy dispensing partner, may experience delays in shipments with UPS due to the holiday season.

 

We are advising sites to plan accordingly and should there be any urgent orders during this timeframe, please immediately contact NextSource Pharmaceuticals by phone at (855) 672-2468, Option 2 or email sabrinakhan@trisourceph.com to request priority for orders. Our daily cutoff during this time will be 2:00pm Eastern Standard Time.

 

Transition Pharmacy will be closed on Wednesday, December 25, 2024 and Wednesday, January 1, 2025 so no orders will be processed on these days.

 

4. CANCER PREVENTION & CONTROL

NRG-CC010: The study is open to NRG sites in Japan and South Korea. The optional biospecimen collection does not apply to sites participating in these countries.


5. GYNECOLOGIC

NRG-GY026: Please note, the post-chemo cfDNA Whole Blood (WB03) should only be collected if the Pre-Treatment cfDNA Whole Blood (WB01) was collected.


NRG-GY031: Please note, there is an error in the section 4.2 table and the Biospecimen Collection and Submission Manual. The Part I PK collection is to be done on Cycle 1, Day 1, and Cycle 1, Day 8. This will be updated with the next amendment.

 

6. HEAD & NECK

NRG-HN008 Reminder: Please update treatment and AE data weekly. This is a Phase I trial and timely data submission is very important.


7. VTOC TRAINING

The VTOC Webinar Training Series schedule and registration is available for NRG Oncology Research Associates working on NRG-HN001, NRG-HN002, NRG-CC003, NRG-CC005, NRG-BR009, NRG-CC011, and NRG/SWOG S1914. Space is limited so register now and reserve your seat. The next webinar training is scheduled for January 8, 2025.

An Investigator’s Brochure (IB) update has been issued for the following study:

DRUG NAME

PROTOCOL

*IB NOTICES

Niraparib

NRG-GU007

X

*The current version of the Investigator Brochure Documents for Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI)-sponsored trials are available for access via the Cancer Therapy Evaluation Program (CTEP) Agent Inventory Management System (AURORA) application. Log-in using your Identity and Access Management (IAM) or ID.me credentials and provide the requested information to access the document.

 

Every site principal investigator is responsible for reviewing this document. The Investigator Brochure is for use by the site principal investigator and any study personnel under his/her supervision who need to know the contents for the conduct of a clinical trial, including Institutional Review Board(s) or Independent Ethics Committee(s).

 

1. Register Today: NRG-HN014 Study Kick-Off Training Webinar

NRG-HN014: “Randomized Phase III Trial of Neoadjuvant Immunotherapy With Response-Adapted Treatment Versus Standard-of-Care Treatment For Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma”. A Study Kick-Off training webinar is scheduled for January 8, 2025 from 1:30-3pm ET. Please register here in advance of the webinar.


2. NCI Cancer Currents Blog Features NRG Oncology Study: NRG-HN004

Cetuximab Outperforms Durvalumab for Head and Neck Cancer When Cisplatin Isn’t an Option Read full blog post here

 

3. PRESS RELEASE: NRG Oncology Study Suggests the Addition of SBRT to Systemic Therapy Improves Outcomes for Select Patients with Locally Advanced Hepatocellular Carcinoma

Recent results from the Phase III NRG-RTOG 1112 clinical study showed that the addition of stereotactic body radiotherapy (SBRT) to systemic therapy with sorafenib significantly improved progression-free survival (PFS) and time-to-progression in patients with locally advanced hepatocellular carcinoma (HCC) when compared to sorafenib alone. Furthermore, the addition of SBRT to sorafenib was associated with clinically important improvements in overall survival (OS) for patients with locally advanced HCC. These results were recently published in JAMA Oncology. The trial was funded by the National Cancer Institute, National Institutes of Health. Read more


4. Translational Science Committee Soliciting Pilot Projects for Inclusion in the NRG UG1 Translational Science Center Application

The NRG Oncology Translational Science Committee is soliciting one-page proposals (with Specific Aims) for pilot projects to incorporate into their “Network Group Integrated Translational Science Center” application due in February 2025. More information available here

 

5. AACR Special Conference in Cancer Research

The AACR Special Conference Meeting will be held January 26-29, 2025 in San Deigo. This is the first meeting focusing on radiation and targeted therapy. The program has many oral and poster presentation opportunities from proffered abstracts in addition to presentations from experts in the field. Please encourage your faculty and trainees to submit abstracts and register for this meeting. Abstract submission is now opened. However, abstract submission is not required for attendance. Looking forward to seeing many of you in San Diego! Registration opens soon, learn more on the AACR website.

6. NRG Member Demographics Data Collection Initiative

We are excited to introduce the NRG Member Demographics Data Collection Initiative that will allow us to create a comprehensive member database, enabling us to better understand and serve our members. Your information will be kept secure and confidential, ensuring that your privacy is always protected. All members are encouraged to complete the form or indicate that they wish to opt out of this data collection initiative. 

 

Scan the QR code below or click this link to access the form. 

Questions? Read more here

7. Reminder: Winter Holiday Closure Information

Winter holiday closure information for the NRG Oncology Operations Offices, Statistics and Data Management Centers (SDMCs), Biospecimen Banks, and McKesson's Clinical Research Services is posted on the CTSU website (under LPO updates).

NRG Oncology is pleased to report the scientific articles that appeared during the previous week as well as abstracts accepted for presentation at scientific conferences.

This publications report includes links, when available, to the article, PubMed abstract, or association abstract.


ACCEPTED ABSTRACTS

Mitchell MP, Braunstein LZ, Bandos H, Sikov WM, Khan AJ, Chen PY, Ganz PA, Jagsi R, D P, White JR, Cecchini RS, Kang H, Puhalla SL, Gergelis K, Julian TB, Mamounas EP, Wolmark N. NRG-BR008: A phase III randomized trial of radiotherapy optimization for low-risk HER2-positive breast cancer (HERO). Miami Breast Cancer Conference. 3/6/2025. Poster Presentation.

 

Mohamad O, Swanson M, Pollack A, Lukka HR, Dal Pra A, Dayes IS, Martin A, Greenberg MJ, Balogh AG, Michalski JM, Vavassis P, Currey AD, Dess RT, Efstathiou JA, Kapadia NS, Patel S, Ahmad B, Sandler HM, Pugh SL, Nguyen PL. The Prognostic Impact of Prostate-Specific Antigen at 6 Months After Post-Prostatectomy Radiotherapy: An Individual Patient Data Analysis of Two NRG Oncology Randomized Trials. ASCO GU. 2/15/2025. Abstr 254. Oral Presentation.

 

PUBLISHED ARTICLES

Guan L, Torres-Saavedra PA, Zhao X, Major MB, Holmes BJ, Nguyen NK, Kumaravelu P, Hodge T, Diehn M, Zevallos JP, Holsinger FC, Emami B, Jordan RC, Hayward MC, Sagar SM, Morrison W, Schultz C, Caudell JJ, Jones CU, Bratman SV, Galloway TJ, Ma DJ, Yom SS, Kudrimoti M, Kim HE, Harris J, Le QT, Hayes DN. Association between Locoregional Failure and NFE2L2/KEAP1/CUL3 Mutations in NRG/RTOG 9512: A Randomized Trial of Radiation Fractionation in T2N0 Glottic Cancer. Clin Cancer Res. 2024 Dec 10. doi: 10.1158/1078-0432.CCR-24-2334. Epub ahead of print. PMID: 39656603. Read more.


Please note the following upcoming meetings and abstract submission deadlines


UPCOMING MEETINGS

American Association for Thoracic Surgery (AATS); May 2-5, 2025; Seattle, WA


American Head & Neck Society (AHNS); May 14-15, 2025; New Orleans, LA

American Radium Society (ARS) Annual Meeting; Apr 3-6, 2025; Seattle, WA


American Society of Clinical Oncology (ASCO) GI; Jan 23-25, 2025; San Francisco, CA


American Society of Clinical Oncology (ASCO) GU; Feb 13-15, 2025; San Francisco, CA


American Surgical Association (ASA); Apr 24-26, 2025; San Diego, CA


Society for Clinical Trials (SCT); May 18-21, 2025; Vancouver, BC


Society for Gynecologic Oncology (SGO); Mar 14-17, 2025; Seattle, WA


Society of Surgical Oncology (SSO) Annual Meeting; Mar 27-29, 2025; Tampa, FL


SSO – Advanced Cancer Therapies; Feb 14-17, 2025; Scottsdale, AZ.


St. Gallen Breast Cancer Conference; Mar 12-15, 2025; Vienna Austria


UPCOMING ABSTRACT SUBMISSION DEADLINES

American Association for Cancer Research (AACR); Apr 25-30, 2025; Chicago, IL; LBA and Clinical Trials Jan 16, 2025, 11:59 pm ET


American Brachytherapy Society (ABS); Jun 18-21, 2025; Nashville, TN; Due to publications committee Jan 21, 2025; Submission deadline Feb 4, 2025, 6:00 pm PT


American College of Radiology (ACR); May 3-7, 2025; Washington, DC; Due to publications committee Jan 13, 2025; Submission deadline Jan 27, 2025, 11:59 pm ET


American Society of Breast Surgeons (ASBrS); Apr 30-May 4, 2025; Las Vegas, NV; LBA Feb 5, 2025 (placeholder required)


American Society of Clinical Oncology (ASCO); May 30-Jun 3, 2025; Chicago, IL; Due to publications committee Jan 14, 2025; Submission deadline Jan 28, 2025; LBA Mar 5, 2025 (placeholder required)


American Society of Colon and Rectal Surgeons (ASCRS); May 11-14, 2025; San Diego, CA; LBA and Clinical Trials Jan 29, 2025, 11:59 pm ET


American Society for Radiation Oncology (ASTRO); Sep 28-Oct 1, 2025; San Francisco, CA; Due to publications committee Feb 11, 2025; Submission deadline Feb 25, 2025, 11:59 pm PT; LBA Jul 10, 2025, 11:59 pm PT


European Society of Gynaecological Oncology (ESGO); Feb 20-23, 2025; Rome, Italy; LBA Jan 15, 2025 (placeholder required)


European Society for Medical Oncology (ESMO); Oct 17-21, 2025; Berlin, Germany; Due to publications committee Apr 25, 2025; Submission deadline May 13, 2025, 21:00 CET; LBA Sep 9, 2025, 21:00 CET (placeholder required)


ESMO Breast Cancer; May 14-16, 2025; Munich, Germany; Due to publications committee Jan 28, 2025; Submission deadline Feb 11, 2025, 21:00 CET; LBA Apr 15, 2025, 21:00 CET (placeholder required)


ESMO Gynaecological Cancers; Jun 19-21, 2025; Vienna, Austria; Due to publications committee Mar 18, 2025; Submission deadline Apr 1, 2025, 21:00 CET


European Society for Radiotherapy and Oncology (ESTRO); May 2-6, 2025; Vienna, Austria; LBA Mar 19, 2025


International Society for Quality-of-Life Research (ISOQOL); Oct 22-25, 2025; Milwaukee, WI; Due to publications committee Mar 25, 2025; Submission deadline Apr 7, 2025



Miami Breast Cancer Conference; Mar 6-9, 2025; Miami, FL; Late submission deadline Jan 1, 2025

 

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