January 16, 2024

NRG Oncology Broadcast archives are accessible from our website at any time. Please bookmark this link for your convenience.

The NRG Oncology 2024 Winter Meeting is Open for Registration!

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

The Role of Spatial Biology in Oncology at #NRG2024

The NRG Translational Science Committee will be hosting their session “The Role of Spatial Biology in Oncology: Opportunities and Challenges for Translational Research” on Thursday, February 15, 2024 from 3-5pm at the upcoming NRG Meeting in Orlando. Presentations include the 3D spatial biology of archived FFPE tissue, new insights and opportunities in spatial biology, the multiplexed tissue imaging for biomarker and translational science discovery, and whole slide imaging mass cytometry for rapid profiling of tumor spatial heterogeneity and immune microenvironments. View the session flyer here. Register here. Click here to view the session flyer.

Winter Symposium - IDEA: Inclusion, Diversity, Equity and Access of Underrepresented Patients to Clinical Trials

Register here for the Winter 2024 Educational Symposium on Thursday, February 15, 2024 from 8am-12pm ET. The symposium will include noted Oncologists and Scientists serving as speakers and moderators. The speakers will focus their presentations on providing a framework for the barriers and solutions to increasing IDEA (Inclusion, Diversity, Equity, and Access) of underrepresented patients to clinical trials. Read more

NRG Oncology Protocol Support Committee – Educational Sessions

Please be sure to sign up to attend the PSC Nurse/CRP Sessions being held during the NRG Oncology Winter Meeting in Orlando. The Protocol Support Committee (PSC) will offer Introduction to Clinical Trials: Principles of NRG Oncology Clinical Trial Management for Nurse/CRPs on Thursday, February 15th; and Continuing Education Session for Nurse/CRPs on Friday, February 16th. These sessions will be held virtually and in-person and are for both seasoned and new research staff. Please refer to the posted flyers and agendas (login required) for more details about the PSC programing offered at #NRG2024.

The PSC is thrilled to announce that the PSC sessions have been approved by the Virginia Nurses Association to award contact hours. The Virginia Nurses Association is accredited as an approver of nursing continuing professional development by the American Nurses Credentialing Center’s Commission on Accreditation.

#NRG2024 Social Media Workshop – Virtual Session

The NRG Oncology Communications Committee is pleased to announce our Social Media Workshop as part of #NRG2024. The workshop, held as a virtual session, is scheduled for Monday, February 12th from 4-5pm ET. Drs. Kristin Higgins and Miriam Knoll, members of the NRG Oncology Communications Committee, are the workshop chairs. The session speakers include Kristen Kimball, advocate for lung cancer awareness and retired physiology instructor from Boston; and Dr. Lucinda Morris, a radiation oncologist and co-chair of the Targeting Cancer initiative, from Sydney, Australia. Please see the session flyer for details. Register here.

AMENDMENTS

GENITOURINARY

NRG-GU011 - Sites in Canada - The NOL and additional forms for amendment 3 are posted on CTSU. Please complete the CTSI and Protocol signature page and submit via the Regulatory submission portal.

NRG-GU010 - Sites in Canada - The NOL and additional forms for amendment 1 are posted on CTSU. Please complete the CTSI and Protocol signature page and submit via the Regulatory submission portal.

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. CANCER CONTROL & PREVENTION

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

4. GENITOURINARY

NRG-GU011: Spanish Translated Informed Consent Form and CIRB approval of Translation posted to CTSU.

5. GYNECOLOGIC

EAY191-N4: Appendix XI, Section II, 1^st bullet: Reports should be REDACTED. Section 10.2: Footnote 2 will be deleted. These changes will be made with the next amendment.

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.

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. LUNG

NRG-LU004: Updated Data Submission Table, Eligibility Checklist, Blank Rave Forms Packet, and Specimen Transmittal Forms have been posted on the NRG Oncology website. 

8. 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, NRG-BR009 and NRG/SWOG S1914. Space is limited so register now and reserve your seat. The next webinar training is scheduled for Wednesday, January 17, 2024.

DRUG SAFETY AND INVESTIGATOR’S BROCHURE (IB) UPDATES

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

*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).

NRG Biobank Pittsburgh Relocation

Please note that the NRG Oncology Biobank Pittsburgh will relocate at the end of January 2024. As of February 1, 2024, the new address will be:

Nova Place

100 South Commons, Suite 120

Pittsburgh, PA 15212

Please refrain from shipping blocks and slides designated to be submitted to the Pittsburgh Biobank from January 22-31. The biobank’s phone number will not change. Please call or e-mail with any questions at 412-697-6611 or NRGbiobankPGH@nrgoncology.org.

Membership Reminders:

Please take a moment to review and update your site person rosters!

NRG Oncology Members are required to designate individuals to fill the NRG Oncology Primary Roles. Primary Roles are:

·        Check Addressee

·        Contact PI

·        LAPS PI

·        Lead RA

·        Co-Lead RA (optional)

·        Local Lead RA

·        Principal Investigator (A maximum of 3 and the contact PI is counted as 1)

These roles are used to communicate with respect to NRG Oncology studies and other important information. In order for a person to be assigned a Primary Role, he/she must have an active CTEP ID and be listed on the site's NRG Oncology Roster for the specific institution. A completed NRG Primary Role Change Form (located on NRG Oncology website, under Membership) must be submitted to roster@nrgoncology.org for any Primary Role changes.

The Roster Update Management System (RUMS) allows authorized people at clinical sites to manage roster data for secondary roles using a web-based application. Authorized persons can use RUMS to manage person secondary roles, to request the addition or withdrawal of persons to their associated clinical sites, and to request the addition or withdrawal of child sites from their local network. NCORP authorized users should request rostering of NCORP sites, investigators, and research associates via NCORP-SYS. A person must be rostered before any roles may be requested in RUMS. 

Required secondary roles are Local PI, Contract Contact, Fiscal Contact.

Please take a moment and review your roster using RUMS or NCORP-SYS as applicable to ensure all of your network personnel are up to date. Contact roster@nrgoncology.org for assistance.

New Request for Early IRB Closure Form

CTSU’s Request for LPO Approval of Early Closure Form is now available on the CTSU website under Resources > CTSU Operations Information > CTSU Forms. This form will replace the NRG Early IRB Closure form. Additional NRG instructions are located on the NRG website. When a site wants to close a study locally prior to study-wide termination, they must complete and submit this form to NRG. If approved, they must then submit it to the NCICIRB via IRBManager or to the CTSU via the Regulatory Submission Portal, whichever is appropriate per the instructions. The CIRB and the CTSU will not process an early closure without documentation that the LPO has approved it. 

NRG Oncology Confidential Member Survey

Please read our survey FAQ’s. All NRG Members should have received an email from the University of Chicago’s Survey Lab containing a unique survey link. If you have not already completed the survey, please check your inbox and possibly your spam/junk mailbox for the email so that you can help us collect this important information. Please send any additional questions to nrg-broadcasts@nrgoncology.org.

NNRG Oncology is pleased to report the following scientific articles that have appeared during the previous week as well as an abstract accepted for presentation at the American Society of Clinical Oncology (ASCO) GI 2024 symposium. This publications report includes links, when available, to the article, PubMed abstract, or association abstract.

PUBLISHED ARTICLES

Chan JK, Tian C, Kesterson JP, Lin KY, Darcy K, Richardson MT, Kapp DS, Monk BJ, McNally L, Landrum L, Copeland L, Walker JL, Wenham RM, Phippen N, Spirtos NM, Tewari K, Shahin M, Berry L, Bell JG. Preoperative and pre-chemotherapy CA-125 levels in high-risk early-stage ovarian cancer - An NRG/GOG study. Gynecol Oncol. 2023 Dec 21;181:54-59. doi: 10.1016/j.ygyno.2023.12.009. Epub ahead of print. PMID: 38134754. Read More.

Rastogi P, O'Shaughnessy J, Martin M, Boyle F, Cortes J, Rugo HS, Goetz MP, Hamilton EP, Huang CS, Senkus E, Tryakin A, Cicin I, Testa L, Neven P, Huober J, Shao Z, Wei R, André V, Munoz M, San Antonio B, Shahir A, Harbeck N, Johnston S. Adjuvant Abemaciclib Plus Endocrine Therapy for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative, High-Risk Early Breast Cancer: Results From a Preplanned monarchE Overall Survival Interim Analysis, Including 5-Year Efficacy Outcomes. J Clin Oncol. 2024 Jan 9:JCO2301994. doi: 10.1200/JCO.23.01994. Epub ahead of print. PMID: 38194616. Read More.

ACCEPTED ABSTRACTS

Ku G, Moughan J, Williams TM, Adusumilli PS, Nishimura M, Yock AD, Mehta R, Klempner SJ, Miller ED, Hong TS. Initial safety assessment of the endoscopically injected oncolytic virus OBP-301 in medically inoperable esophageal cancer: NRG-GI007. ASCO GI 2024. 1/18/2024. Poster Presentation.

ASCRS 2024: Submit Late Breaking Abstracts including High-Impact Colorectal-Anal Clinical Trials and TiP

For the first time ever, the American Society of Colon and Rectal Surgeons (ASCRS) annual meeting will have a ‘Late Breaking Clinical Trial’ section. Investigators are invited to submit abstracts of clinical trials, including approved trials, trials-in-progress and completed trials, for presentation at a newly dedicated session at the ASCRS 125^th Anniversary Annual Scientific Meeting, being held in Baltimore, June 1-4, 2024.

This is a great opportunity for investigators looking to get more surgeon engagement, enhance recruitment and/or make surgeons aware of their results. There are no restrictions on previously presented data and/or work that is currently under review or accepted for publication. The meeting submission deadline is February 13, 2024. Investigators interested in submitting an abstract to the ASCRS meeting should have a draft to the NRG Publications Department by January 29, 2024. Click here for more information.

Please note the following upcoming meetings and abstract submission deadlines

UPCOMING MEETINGS

American Association for Cancer Research (AACR); Apr 5-10, 2024; San Diego, CA

American Association for Thoracic Surgery (AATS); Apr 27-30, 2024; Toronto, ON

American College of Radiology (ACR); Apr 13-17, 2024; Washington, DC

American Head & Neck Society (AHNS); May 15-16, 2024; Chicago, IL

American Radium Society (ARS); May 2-5, 2024; Palm Springs, CA

American Society of Breast Surgeons (ABS); Apr 10-14, 2024; Orlando, FL

American Society of Clinical Oncology (ASCO) GI; Jan 18-20, 2024; San Francisco, CA

American Society of Clinical Oncology (ASCO) GU; Jan 25-27, 2024; San Francisco, CA

Society for Clinical Trials (SCT); May 19-22, 2024; Boston, MA

Society of Gynecologic Oncology (SGO); Mar 16-18, 2024; San Diego, CA

Society of Surgical Oncology (SSO); Mar 20-23, 2024; Atlanta, GA

Society of Surgical Oncology (SSO) - Advanced Cancer Therapies (ACT); Feb 16-19, 2024; San Juan, Puerto Rico

UPCOMING ABSTRACT SUBMISSION DEADLINES

American Brachytherapy Society (ABS) World Congress; Jul 10-13, 2024; National Harbor, MD; due to publications committee Feb 13, 2024; submission deadline Feb 27, 2024, 6:00 pm PT

American Society of Clinical Oncology (ASCO); May 31-Jun 4, 2024; Chicago, IL; due to publications committee Jan 23, 2024; submission deadline Feb 6, 2024, 11:59 pm ET; LBA Mar 11, 2024, 11:59 pm ET (placeholder required)

American Society of Colon and Rectal Surgeons (ASCRS); Jun 1-4, 2024; Baltimore, MD; submission deadline Feb 13, 2024, 11:59 pm PT

American Society for Radiation Oncology (ASTRO); Sep 29-Oct 2, 2024; Washington, DC; due to publications committee Feb 27, 2024; submission deadline Mar 12, 2024; LBA Jul 12, 2024

EORTC-NCI-AACR Symposium on Molecular Targets and therapies; Oct 23-25, 2024; Barcelona, Spain; due to publications committee Jun 13, 2024; submission deadline Jun 27, 2024; LBA Sep 26, 2024

European Society of Gynaecological Oncology (ESGO); Mar 7-10, 2024; Barcelona, Spain; LBA Jan 15, 2024



European Society for Medical Oncology (ESMO); Sep 13-17, 2024; Barcelona, Spain; due to publications committee Apr 23, 2024; submission deadline May 7, 2024, 21:00 CET; LBA Aug 7, 2024, 21:00 CET (placeholder required)