March 18, 2024

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AMENDMENT

GYNECOLOGIC

The following protocol amendment is in response to an NCI action letter for CTEP-supported studies that involve PHESGO:

NRG-GY026: Amendment 6; protocol version date: February 23, 2024 (posted on CTSU)

CLOSURE

BRAIN

NRG-BN005: This study will be closing to accrual at 5pm ET Tuesday, March 19, 2024, because it has reached its accrual target. All patients registered to Step 1 registration by 5pm ET on March 19 will be permitted to proceed to the randomization step (Step 2). Reminder: Data collection and site IRB renewal for closed studies must continue until the study is terminated.

FORM UPDATES

1. GENITOURINARY

NRG-GU010: Updated Darolutamide Pill Diary is posted on CTSU.

2. HEAD & NECK

NRG-HN011: The Specimen Transmittal EBV form haENIs been updated. The updated version is available on CTSU. Please begin using this new form immediately.

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

San Francisco Biospecimen Bank (NRGBB-SF) database migration

NRGBB-SF will be changing their biospecimen database in late March/early April 2024. Due to this change, NRGBB-SF requests that institutions with the capacity to store their samples collected for biobanking, do so on-site. Do not ship samples to the NRGBB-SF bank between March 11-April 8, 2024.

• During this time, NRGBB-SF will not provide routine return airbills for frozen shipments without prior authorization and will not be accepting large batch of international/domestic frozen specimens.
• If your site cannot store frozen samples, please contact the bank for prior authorization to ship frozen samples.
• Protocols with mandatory central review or fresh blood processing: These samples can be shipped at any time as usual; database change will not impede patient care or treatment.
• FFPE samples are not affected by this change, sites may ship these as needed. Collection kits may be requested as usual.
• Shipments to the Pittsburgh or Columbus bank are not affected by this change, shipments can be sent as usual.

3. BREAST

NRG-BR004: Call for submission of data. Refer to the memo, dated March 13, 2024, posted on CTSU.

NRG-BR007/DEBRA: Updated Pathology Instructions (dated March 11, 2024) posted on CTSU

4. CANCER PREVENTION & CONTROL

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.

5. DATA MONITORING COMMITTEE (DMC) MINUTES

The Feb 2024 Data Monitoring Committee (DMC) minutes for studies that are on the NCI CTSU menu are available on the CTSU website. The Feb 2024 Data Monitoring Committee (DMC) minutes for studies that are not available on the CTSU website are located on the NRG Oncology website.

6. 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.

7. 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.

DRUG SAFETY REPORTS

1. Health Disparities Committee Symposium

The NRG Oncology Health Disparities Committee (HDC) will be hosting their annual symposium on Tuesday, April 16, 2024; 3-4:30pm ET. The focus of this year’s symposium will be “Aligning Clinical Trial Development with an Aging Population: Challenges and Opportunities for Older Adults with Cancer.” Refer to the agenda or the flyer for details. Please register in advance for this webinar. After registering, you will receive an email with the webinar link.

2. NRG Oncology Currents

The March issue of the NRG Currents eNewsletter is now available. This edition includes #NRG2024 highlights, the monthly PSC column, Colorectal Cancer Awareness Month featuring GI trials in progress, information about the newly activated NRG-CC011 trial, and more! Click here to view: March 2024 issue

3. PRESS RELEASE: Hypofractioned Post-Prostatectomy Radiotherapy New Acceptable Practice Standard Based on NRG Oncology Trial Findings

Results from the Phase III NRG Oncology NRG-GU003 clinical trial comparing hypofractioned post-prostatectomy radiotherapy (HYPORT) to conventionally fractioned post-prostatectomy radiotherapy (COPORT) determined that HYPORT was non-inferior to COPORT in terms of late gastrointestinal (GI) or genitourinary (GU) toxicity for patients primarily treated with prostatectomy for their prostate cancer. HYPORT was not associated with significantly higher patient-reported GU or GI symptoms at 1-2 years following radiotherapy, thus indicating HYPORT can be used as an acceptable new practice standard. There was greater short-term GI toxicity, mostly rectal irritation, associated with HYPORT as one would expect with the shorter regimen, but this difference resolved at 6 months following radiotherapy. These results were recently published in the JAMA Oncology. Read more

4. 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 <noreply@qemailserver.com> 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.

5. Developing and Running an R01 Through NRG NCORP – Register for the webinar to be held on Thursday, April 11, 1-2:30pm ET

Participants will learn about the NRG NCORP concept review process with a specific focus on R01s.

Dr. Von Ah and Dr. Sikorskii will present their recent experiences R01 concepts through the NRG NCORP, along with lessons learned and benefits of utilizing the NRG NCORP process. A panel of professionals will also be available to discuss their experiences and answer questions from attendees.

The flyer with agenda can be found here.

Register in advance for this meeting. After registering, you will receive an email with the meeting link.

6. Membership Updates & Reminders

A new form, “Role Change Form,” has been added to the NRG Oncology website. This form is to be used for ALL primary role changes.

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.

NRG Oncology is pleased to report the scientific articles that have appeared during the previous week as well as an abstract accepted for presentation at the upcoming American Society of Colon & Rectal Surgeons (ASCRS) meeting in June.

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

ACCEPTED ABSTRACTS

Rojas-Khalil Y, Yu G, Kopetz S, Jacobs SA, Lucas PC, Sahin IH, Deming DA, Philip PA, Hong TS, Loree J, Wolmark N, Yothers G, George TJ, Lieu CH, Dasari A. NRG-GI008: Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease (CIRCULATE-US). ASCRS (American Society of Colon and Rectal Surgeons). 6/1/2024. Abstr eP826.

PUBLISHED ARTICLES

Mamounas EP, Bandos H, Rastogi P, Zhang Y, Treuner K, Lucas PC, Geyer CE, Fehrenbacher L, Chia SK, Brufsky AM, Walshe JM, Soori GS, Dakhil S, Paik S, Swain SM, Sgroi DC, Schnabel CA, Wolmark N. Breast Cancer Index and Prediction of Extended Aromatase Inhibitor Therapy Benefit in Hormone Receptor-positive Breast Cancer from the NRG Oncology/NSABP B-42 Trial. Clin Cancer Res. 2024 Feb 20. doi: 10.1158/1078-0432.CCR-23-1977. Epub ahead of print. PMID: 38376912. Read more.

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 Brachytherapy Society (ABS) World Congress; Jul 10-13, 2024; National Harbor, MD

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

American Head and 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); May 31-Jun 4, 2024; Chicago, IL

American Society of Colon and Rectal Surgeons (ASCRS); Jun 1-4, 2024; Baltimore, MD

European Society for Medical Oncology (ESMO) Breast Cancer; May 15-17, 2024; Berlin, Germany

European Society for Radiotherapy and Oncology (ESTRO); May 3-7, 2024; Glasgow, Scotland

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

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

UPCOMING ABSTRACT SUBMISSION DEADLINES

American Society for Radiation Oncology (ASTRO); Sep 29-Oct 2, 2024; Washington, DC; 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 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)

European Society for Medical Oncology (ESMO) Gastrointestinal; Jun 26-29, 2024; Munich, Germany; due to publications committee Mar 26, 2024; submission deadline Apr 9, 2024, 21:00 CET; LBA Jun 6, 2024, 21:00 CET (placeholder required)

European Society for Medical Oncology (ESMO) Gynaecological; Jun 20-22, 2024; Florence, Italy; due to publications committee Mar 20, 2024; submission deadline Apr 3, 2024, 21:00 CET

International Society for Quality-of-Life Research (ISOQOL); Oct 13-16, 2024; Cologne, Germany; due to publications committee Mar 25, 2024; submission deadline Apr 8, 2024, CET



International Gynecologic Cancer Society (IGCS); Oct 16-18, 2024; Dublin, Ireland; due to publications committee Apr 16; submission deadline Apr 30, 2024, 23:59 IST; LBA Jul 2, 2024, 23:59 IST