September 25, 2023

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PSC Accepting Applications for Membership

Submission Deadline: September 29, 2023


·       Click here for the Core membership application 

·       Click here for the General membership application


CLOSURE

GENITOURINARY

NRG-GU009: The QOL substudy has reached its accrual target for the de-intensification study (Arms 1 and 2). Please see the study memorandum, dated September 22, 2023. (posted on CTSU)


OTHER PROTOCOL NOTICES

1. ALL DISEASE SITES

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

 

2. BIOSPECIMEN BANK

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. GASTROINTESTINAL

NRG-GI002: Permanent Study Closure (posted on CTSU)


4. GYNECOLOGIC

GOG-0210: Reminder: 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.

 

5. 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.

  

6. 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, October 4, 2023.

 

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 REPORTS

INVESTIGATOR’S

BROCHURE (IB)*

Atezolizumab

NRG-BN010

NRG-BR004

NRG-GI004/

SWOG-S1610

NRG-GY009

NRG-LU002

NRG-LU005

NRG-LU007

RTOG 1216

CTSU

CTSU

CTSU


CTSU

CTSU

CTSU

CTSU

CTSU

X




X

X

X

X

X

Durvalumab

NRG-GY012

NRG-GY023

NRG-HN004

NRG-LU004

RTOG 1308


CTSU

CTSU

CTSU

NRG

CTSU



Ipilimumab

NRG-BN002

NRG-BN007

NRG-GY025

NRG-GU012

NRG-LU002


NRG

CTSU

NRG

CTSU

CTSU



Nivolumab

NRG-BN002

NRG-BN007

NRG-GY025

NRG-GU012

NRG-HN005

NRG-HN007

NRG-LU002


NRG

CTSU

NRG

CTSU

CTSU

CTSU

CTSU



Pembrolizumab

NRG-GY018

NRG-GY020

NRG-HN003

NRG-LU002


CTSU

CTSU

NRG

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) 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. Annual Call for NRG Oncology Committee Member Applications

Are you interested in serving on an NRG Oncology committee? NRG Oncology depends on its members to advance its mission. Our members help drive our research, develop protocols, contribute to our science, and so much more. If you are interested in serving on an NRG Oncology research committee, or if you are a member who had previously served on a committee and would like to re-engage please consider applying by following the instructions in the 2023 NRG ONCOLOGY GENERAL AND CORE COMMITTEES APPLICATION FORM and submitting a complete application.

All applications must be submitted by midnight ET on Friday, October 6, 2023. Current committee members do not need to reapply.

The next call for applications for core and general committees will occur in the Fall 2024.

 

2. Call for Health Equity Fellowship Applications

NRG Oncology is pleased to announce that it is partnering with the ASTRO and RTOG Foundation to offer a Health Equity Fellowship with an emphasis on radiation oncology. In addition, there is an opportunity for researchers involved in ovarian cancer prevention research, supported by the West Valley Ovarian Cancer Alliance (WVOCA). Applications are due September 29, 2023 (submit to Fellowships@NRGOncology.org). Please refer to the NRG Oncology website for more information.

 

3. NRG Oncology Patient Advocate Committee - Call for Volunteer Candidates

We are currently recruiting volunteer(s) for the Patient Advocate Committee from Canadian member sites. Individuals wishing to apply should send a letter of interest to Dorothy Erlanger, Patient Advocate Committee Chair, at derlanger@erlanger-inc.com, and Raechel Huff: huffr@nrgoncology.org. The application window will close on September 29, 2023. Details about the committee, the role of the position, and how to apply may be found here.


4. PSC Accepting Applications for Membership

The NRG Oncology Protocol Support Committee (PSC) is soliciting applications for Core and General membership. If you are interested in helping to facilitate the goals of the PSC and provide support with quality control of protocol-related activities, education and training of NRG Oncology members on relevant topics, communication and mentorship, please consider applying. The deadline for application submission is Friday, September 29, 2023.


·       Click here for the Core membership application 

·       Click here for the General membership application


5. Applications for NRG Oncology Clinical Research Coordinator Mentor Program Now Open

The NRG Oncology Mentorship Working Group is now accepting applications for mentors. The primary goal of the NRG Oncology Research Coordinator Mentor Program is to support new CTNs and CRAs in their NRG roles at NRG Oncology member institutions. A description of the mentor program and the qualifications can be found on the NRG Oncology website under the Nurses & CRAs tab. Please email your application to the NRG Oncology PSC Mentorship mailbox at pscmentorship@NRGOncology.org, with subject line: “Mentor Application”. The deadline for application submission is Friday, September 29, 2023.


6. NEW NCORP Pilot Grant Application Process – Register for the Q&A Session to be held September 27, 2023

In follow up to the informational session held on September 11, 2023, the NCORP committee chairs will be hosting a Q&A session on September 27, 2023 from 2- 2:30 PM ET. Please review the recording and slides (available here) and bring any questions you may have to this session. Register here for the Q&A session.

  • The request for funding application (RFA) for NCORP pilot projects will be released in Spring 2024. However, anyone interested in applying for this RFA must submit a Letter of Intent (LOI); due November 3, 2023. Click here to download the form
  • NCORP committee chairs will review LOIs and select those best aligned with committee goals, NCORP priorities and feasible.
  • Selected investigators will be notified and invited to attend a workshop at #NRG2024 Winter Meeting in Orlando, Florida; February 15-17, 2024.


7. Data Collection Transition to Medidata Rave

Impacted Studies: NRG/RTOG-0534, NRG/RTOG-0724, NRG/RTOG-0815, NRG/RTOG-0848, NRG/RTOG-0920, NRG/RTOG-0924, NRG/RTOG-1005, NRG/RTOG-1008, NRG/RTOG-1016. Effective Wednesday, September 27, 2023 at 5:00pm ET, the database (accessed via the Data Center Login on rtog.org) for the above studies will be shut down to data entry (including revision of previously submitted data). Please read the memo for important information regarding this transition.

NRG Oncology is pleased to report the scientific articles that have appeared during the previous week and abstracts accepted for poster presentations at the upcoming San Antonio Breast Cancer Symposium in December. This publications report includes links, when available, to the article, PubMed abstract, or association abstract.


NRG Oncology presentations at ASTRO Annual Meeting

The flyer listing NRG Oncology research being presented at the ASTRO Annual Meeting, held in San Diego form October 1-4, 2023, is posted on the NRG Oncology website.


JOURNAL ARTICLES

Weidhaas JB, Hu C, Komaki R, Masters GA, Blumenschein GR, Chang JY, Lu B, Dicker AP, Bogart JA, Garces YI, Narayan S, Robinson CG, Kavadi VS, Greenberger JS, Koprowski CD, Welsh JW, Gore E, MacRae RM, Paulus R, Bradley J. The inherited KRAS-variant as a biomarker of Cetuximab Response in NSCLC. Cancer Res Commun. 2023 Sep 20. doi: 10.1158/2767-9764.CRC-23-0084. Epub ahead of print. PMID: 37728512. Read More

 

ACCEPTED ABSTRACTS

Braunstein LZ, Mitchell MP, Bandos H, Sikov WM, Khan A, Chen PY, Ganz PA, Jagsi R, White J, Cecchini RS, Kang H, Puhalla SL, Bolton K, Connoly E, Stringer-Reasor E, 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). SABCS 2023 Poster Presentation.

 

Mamounas EP, Tang G, Puhalla SL, Swain SM, Ganz PA, Henry NL, Cecchini RS, Reid S, Rastogi P, Geyer CE, White J, Clark AS, Haddad TC, Vidal GA, Wolmark N. NRG-BR009: Phase III Trial Evaluating Addition of Adjuvant Chemotherapy to Ovarian Function Suppression + Endocrine Therapy in Premenopausal Women with pN0-1, HR+/HER2- Breast Cancer and Oncotype Recurrence Score ≤25 (OFSET). SABCS 2023 Poster Presentation.

 

White J, Cecchini RS, Harris EER, Mamounas EP, Stover DG, Ganz PA, Jagsi R, Bergom C, Theberge V, El-Tamer M, Zellars RC, Shumway DA, Chen GP, Anderson SJ, Julian TB, Wolmark N. A phase III trial evaluating De-escalation of Breast Radiation (DEBRA) following breast-conserving surgery (BCS) of stage 1, HR+, HER2-, RS ≤18 breast cancer: NRG-BR007. SABCS 2023 Poster Presentation. 

 

Please note the following upcoming meetings and abstract submission deadlines


UPCOMING MEETINGS

AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics; Oct 11-15, 2023; Boston, MA


American Society for Radiation Oncology (ASTRO); Oct 1-4, 2023; San Diego, CA


European Society of Gynaecological Oncology (ESGO); Sep 28-Oct 1, 2023; Istanbul, Turkey


European Society for Medical Oncology (ESMO) Congress; Oct 20-24, 2023; Madrid, Spain


International Gynecologic Cancer Society (IGCS); Nov 5-7, 2023; Seoul, South Korea


International Society for Quality-of-Life Research (ISOQOL); Oct 18-21, 2023; Calgary, AB


PA Breast Cancer Coalition (PBCC); Oct 17, 2023; Harrisburg, PA


Radiological Society of North America (RSNA); Nov 26-30, 2023; Chicago, IL


Society for Immunotherapy of Cancer (SITC); Nov 3-5; San Diego, CA


Society for NeuroOncology (SNO); Nov 15-19, 2023; Vancouver, BC


UPCOMING ABSTRACT SUBMISSION DEADLINES

American Association for Cancer Research (AACR) Annual Meeting; Apr 5-10, 2024; San Diego, CA; due to publications committee Nov 2, 2023; submission deadline Nov 16, 2023, 11:59 PM ET; LBA Jan 8, 2024, 11:59 PM ET


American Association for Thoracic Surgery (AATS) Annual Meeting; Apr 27-30, 2024; Toronto, ON; due to publications committee Oct 2, 2023; submission deadline Oct 16, 2023, 11:59 PM ET


American Head & Neck Society (AHNS) Annual Meeting; May 15-16, 2024; Chicago, IL; due to publications committee Oct 20 ,2023; submission deadline Nov 3, 2023, 5:00 PM ET


American Society of Clinical Oncology (ASCO) GI; Jan 18-20, 2024; San Francisco, CA; LBA Oct 19, 2023, Noon ET


American Society of Clinical Oncology (ASCO) GU; Jan 25-27, 2024; San Francisco, CA; submission deadline Sep 26, 2023, 11:59 pm ET; LBA Oct 26, 2023, Noon ET


American Society of Colon and Rectal Surgeons (ASCRS) Annual Scientific Meeting; Jun 1-4, 2024; Baltimore, MD; due to publications committee Oct 16, 2023; submission deadline Oct 29, 2023, 11:59 PM PT


San Antonio Breast Cancer Symposium (SABCS); Dec 5-9, 2023; LBA Sep 30, 2023, 11:59 PM CT


Society of Gynecologic Oncology (SGO) Annual Meeting; Mar 16-18, 2024; San Diego, CA; due to publications committee Sep 22, 2023; submission deadline Oct 6, 2023


Society for Urologic Oncology (SUO); Nov 28-Dec 1, 2023; Washington DC; LBA Oct 1, 2023


 

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