December 12, 2022

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WEEKLY HIGHLIGHT

NRG Oncology Winter Semiannual Meeting registration is open!




 

Register Here

Registration is now open for the NRG Oncology Winter 2023 Meeting to be held both in Orlando and virtually, January 26-28, 2023.


Click here to register today!


(Registrations after January 3rd will incur a late registration fee)


Social Media Ambassadors wanted for #NRG2023

Looking for a few good folks – in-person or virtual! Apply now to be a #NRG2023 Social Media Ambassador for the NRG Oncology Winter Meeting being held in January 26-28, 2023 in Orlando, FL! If interested, please send an e-mail (& please include your Twitter handle) to: shepardm@nrgoncology.org or send us a DM on Twitter by January 16.

CLOSURES & SUSPENSIONS

BRAIN

NRG-BN010: Temporary Closure Notice dated December 2, 2022 (posted to CTSU). The trial is temporarily closed to accrual for a protocol-specified analysis of safety and tolerability. 

 

GYNECOLOGIC

NRG-GY018: The study closed to accrual as of December 6, 2022, because it has reached its accrual target. Data collection and site IRB renewal for closed studies must continue until the study is terminated. Patients entered into Step 1 prior to study closure on December 6, 2022, will be able to proceed to Step 2. Step 2 randomization must be completed BY 5pm ET on December 20, 2022.


AMENDMENTS

BRAIN

NRG-BN010: Amendment 1, version date November 14, 2022 (posted to CTSU)


OTHER PROTOCOL NOTICES

1. ALL DISEASE SITES

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

 

2. BREAST

NRG-BR007: Study Overview Webinars are being held on January 17, 2023, at 11am ET and 4pm ET. Please see the memorandum posted on CTSU for more information and for how to register by January 12.


3. CANCER PREVENTION & CONTROL

NRG-CC008: Updated Surgeon Training Slides are now available. Additionally, the FACT-ES is now available in Spanish and Chinese. These documents are posted on the CTSU website.

 

4. GENITOURINARY

NRG-GU007: Attention sites with NRG-GU007 open, we are currently enrolling to Dose Level 3, the final dose level for the phase I portion of the trial. More than ever, we need your support in reaching Dose Level 3 target accrual goal to complete the dose finding component of this trial and allow us to progress to the randomized phase II component. Please help us meet this target! Protocol documents for this trial are available on the CTSU website and please share our NRG-GU007 patient brochure with any eligible patients. Questions regarding this trial can be directed to the study Project Manager, Erin Moye at moyee@nrgoncology.org


5. GYNECOLOGIC

Printing Biospecimen Transmittal PDFs on GYN Trials

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

 

GOG-0210: Biospecimens, biomarker data, clinical data, and epidemiologic data are available for request. Please visit the NRG Oncology website for more information on this important study with the overall goal of improving the outcome and/or quality of life for patients with endometrial cancer.

 

NRG-GY009: In preparation for final analysis, sites are asked to please submit all forms due and address all outstanding queries no later than Friday, December 16th, 2022. Data should be entered in Medidata Rave. Your help at this busy time of year is much appreciated! Please contact Linda Gedeon with any questions regarding data entry for this protocol at gedeonl@nrgoncology.org.

 

NRG-GY012 and NRG-GY023: BLOOD PRESSURE CUFF SUPPLY IS VERY LIMITED - Please check your supplies on site for any overlooked cuffs prior to ordering. We request that you order only what is absolutely necessary for your site. VWR has asked that orders are limited to two blood pressure cuffs at a time. Please note that it can take up to three business days to receive cuffs after ordering, so plan accordingly. Thank you for your cooperation.  

 

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 RTOG 0924, RTOG 0920, NRG-HN001, NRG-HN002, NRG-CC003, NRG-CC005, and NRG/SWOG S1914. Space is limited so register now and reserve your seat. The next webinar training is scheduled for Wednesday, December 14, 2022.

DRUG SAFETY AND INVESTIGATOR’S BROCHURE (IB) UPDATES

Drug Safety and Investigator’s Brochure updates have been issued for the following studies:

DRUG NAME

PROTOCOL

WEBSITE FOR SAFETY UPDATES

INVESTIGATOR'S BROCHURES

Copanlisib

NRG-GY029

CTSU

X

Nivolumab

NRG-GY025

CTSU


*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) Online Agent Order Processing (OAOP) website. Log-in using your Identity and Access Management (IAM) username and password 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).

Winter Holiday Closure Information

Winter holiday closure information for the NRG Oncology Operations Offices, Statistics and Data Management Centers (SDMCs), Biospecimen Banks, Serum Bank, and McKesson's Clinical Research Services is posted on the CTSU website (please see the memoranda dated December 12, 2022 for this information).

 

NRG Oncology Biospecimen Bank – Columbus Holiday Event

The NRG Biospecimen Bank - Columbus will be closed from 12-2 pm EST on Monday, December 12 for staff to attend a holiday event. If you need to contact the Biospecimen Bank during this time, please leave a message and someone from the bank will respond as soon as possible. Phone: 614-722-2865 or e-mail: BPCBank@nationwidechildrens.org

 

Cancer Care Delivery Research Webinar Recording – Now Available

The recording of the NRG CCDR Artificial Intelligence Webinar hosted by Drs. Julian Hong and Michael Gensheimer is now available on the NRG CCDR webpage.


Request for PILOT Project Applications

Date Issued: December 1, 2022

Submission Due Date: February 17, 2023


NRG Oncology NCORP solicits PILOT projects addressing NRG NCORP Health Disparities Research (HDR) priorities. PILOT projects should generate preliminary data and address feasibility issues to inform the development of a future NCORP concept. The current focus of HDC is to move past simply documenting outcome differences to the development and testing of interventions to remedy them. Applications for this award should address committee priorities including:


  • Focus 1. Development of interventional studies to decrease health disparities among disparity populations, including racial and ethnic minorities, residents in rural geographic areas, and individuals from other medically underserved groups.
  • Focus 2. Testing interventional studies for optimal care of at-risk elderly.
  • Focus 3. Identify optimal access to cancer screening, treatment, symptom management and surveillance among diverse disparity populations.


Please see full details located on the NRG Health Disparities Committee webpage.


Biospecimen Bank San Francisco Shipping Update

Due to an ongoing strike by some employees at the University of California, the NRG Oncology Biospecimen Bank San Francisco located at UCSF is requesting sites to use Fed Ex for all shipments to the bank until further notice. UPS deliveries to the San Francisco bank cannot be guaranteed during the strike. Please use Federal Express for specimen shipments or delay non-urgent shipments at this time. Please contact the lab at NRGBB@UCSF.EDU prior to resuming shipping by UPS.

PUBLICATIONS REMINDERS

NRG Oncology is pleased to report the scientific articles and abstracts that have appeared or have been presented during the previous week. This publications report includes links, when available, to the article, PubMed abstract, or association abstract.


JOURNAL ARTICLES

McKenzie E, Zhang S, Zakariaee R, Guthier CV, Hakimian B, Mirhadi A, Kamrava M, Padda SK, Lewis JH, Nikolova A, Mak RH, Atkins KM. Left Anterior Descending Coronary Artery Radiation Dose Association with All-Cause Mortality in NRG Oncology Trial RTOG 0617. Int J Radiat Oncol Biol Phys. 2022 Nov 24:S0360-3016(22)03565-9. doi: 10.1016/j.ijrobp.2022.11.033. Epub ahead of print. PMID: 36436615. Read more

 

Unger JM, LeBlanc M, George S, Wolmark N, Curran WJ Jr, O'Dwyer PJ, Schnall MD, Mannel RS, Mandrekar SJ, Gray RJ, Zhao F, Bah M, Vaidya R, Blanke CD. Population, Clinical, and Scientific Impact of National Cancer Institute's National Clinical Trials Network Treatment Studies. J Clin Oncol. 2022 Dec 8:JCO2201826. doi: 10.1200/JCO.22.01826. Epub ahead of print. PMID: 36480773. Read more

 

ACCEPTED ABSTRACTS

American Society of Clinical Oncology (ASCO) GU

Spratt DE, Liu VY, Yamashita R, Chen E, DeVries S, Ross AE, Jia AY, Morgan TM, Rosenthal SA, Sandler HM, Mohamed O, Esteva A, Monson JM, Chmura SJ, Carson JH, Hartford AC, Chang AJ, Pugh SL, Tran PT, Feng FY. Patient-level data meta-analysis of a multi-modal artificial intelligence (MMAI) prognostic biomarker in high-risk prostate cancer: results from six NRG/RTOG phase III randomized trials. ASCO GU. 2/16/2023. 391286

 

Please note the following upcoming meeting and abstract submission deadline dates


UPCOMING MEETINGS

American Society of Clinical Oncology (ASCO) GI; Jan 19-21, 2023; San Francisco, CA


American Society of Clinical Oncology (ASCO) GU; Feb 16-18, 2023; San Francisco, CA


ESMO Gynaecological Cancers Annual Congress 2023; Feb 23-24, 2023; Barcelona, Spain


Society of Surgical Oncology (SSO); March 22-25, 2023; Boston, MA

 

UPCOMING ABSTRACT SUBMISSION DEADLINES

American Association for Cancer Research (AACR); Apr 14-19, 2023; Orlando, FL; LBA Jan 12, 2023


American Society of Clinical Oncology (ASCO); Jun 2-6, 2023; Chicago, IL; due to publications committee Jan 24, 2023; meeting submission deadline Feb 14, 2023 1159 pm EST; LBA Mar 16, 2023 Noon (EST)


American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium; Feb 16-18, 2023; San Francisco, CA; LBA Dec 13, 2022, Noon (EST)


European Society for Radiotherapy and Oncology (ESTRO); May 12-16, 2023; Vienna, Austria; LBA Jan 18, 2023, 9 pm EST


St. Gallen Breast Cancer Conference (SG-BCC); Mar 15-18, 2023; Vienna, Austria; meeting sub meeting submission deadline Dec 16, 2022

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