April 8, 2024

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AMENDMENTS

HEAD & NECK

RTOG 1016: Amendment 10, version dated March 8, 2024, posted on CTSU.

OTHER PROTOCOL NOTICES

1. ALL DISEASE SITES

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

2. BIOSPECIMEN BANKS

Serum Bank samples transition

Please note that the NRG Oncology Serum Bank at Baylor College of Medicine will be transitioning NRG samples to the NRG Biobank Pittsburgh soon. More details to come. Visit the NRG Oncology website for updates.

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. BREAST

NRG-BR007/DEBRA: Study overview webinars are being held via Microsoft Teams on April 19 from 2-3pm ET and April 26 from 12-1pm ET. Please see the memorandum, dated March 25, 2024, (posted on CTSU) for details and how to register for one of the sessions. Please note: Google Chrome is the preferred browser to register for the webinars. 

NRG-BR008/HERO: Study overview webinars are being held via Microsoft Teams on April 30 at 3pm ET and May 1 at 11am ET. Please see the memorandum, dated April 1, 2024, (posted on CTSU) for details and how to register for one of the sessions. Please note: Google Chrome is the preferred browser to register for the webinars.

4. CANCER PREVENTION & CONTROL

NRG-CC005/FORTE: FORTE Fridays Newsletter



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. GYNECOLOGIC

EAY191-N4 (ComboMATCH): 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. 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 Wednesday, April 10, 2024.

1. PRESS RELEASE: NRG Oncology Announces New Leadership of Cancer Prevention & Control Committee

NRG Oncology, a National Cancer Institute (NCI) National Clinical Trials Network (NCTN) group focused on improving outcomes for adults with cancer through multi-center clinical research, recently announced a new Chair and Vice Chair of the organization’s Cancer Prevention and Control (CPC) Committee. Read the press release

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

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 developing R01s 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.

3. 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.

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 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.

NRG Oncology is pleased to report the following report the following scientific articles that have appeared during the previous week as well as abstracts accepted for presentation at the American Society of Clinical Oncology (ASCO) 2024 symposium.

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

ACCEPTED ABSTRACTS

Abrams RA, Winter KA, Goodman KA, Regine WF, Safran HP, Berger AC, Guha CS, Kachnic LA, Gillin MT, Seaward SA, Wu AJ, Wu JJ, Aljumaily RM, DiPetrillo TA, Geva R, Anne PR, Yannucci J, Liles DK, Moughan J, Crane CH. NRG Oncology/RTOG 0848: Results After Adjuvant Chemotherapy +/- Chemoradiation for Patients with Resected Head of Periampullary Pancreas Adenocarcinoma (PA). ASCO (American Society of Clinical Oncology). Oral Presentation. 5/31/2024.  

Braunstein LZ, Mitchell MP, Bandos H, Sikov WM, Khan AJ, Chen PY, Ganz PA, Jagsi R, White JR, Cecchini RS, Kang H, Puhalla SL, Bolton KL, Connolly E, Stringer-Reasor E, Gergelis K, Julian TB, Mamounas EP, Wolmark N. A phase III randomized trial of radiotherapy optimization for low-risk HER2-positive breast cancer (HERO): NRG-BR008. ASCO (American Society of Clinical Oncology). Poster Presentation. 6/2/2024. Abstr TPS613.

Corn BW, Paulus R, Gondi V, Mehta MP, Fogh SE, Wefel JS, Videtic GM, Sun A, Yoon H, Heinzerling JH, McGarry RC, Kundapur V, Devisetty K, Wu A, Kanner AA, Pugh SL, Movsas B, Kachnic LA. "Hope" Drives Quality of Life in Patients with Brain Metastases, But, the "Hope Center" Remains Elusive: An Analysis of NRG-CC003. ASCO (American Society of Clinical Oncology). Oral Presentation. 5/31/2024. Abstr 12011.

Dasari A, Yu G, Kopetz S, Jacobs SA, Lucas PC, Sahin IH, Deming DA, Philip PA, Hong TS, Rojas-Khalil Y, Loree J, Wolmark N, Yothers G, George TJ, Lieu CH. Colon adjuvant chemotherapy based on evaluation of residual disease (CIRCULATE-NORTH AMERICA): NRG-GI008. ASCO (American Society of Clinical Oncology). Poster Presentation. 6/1/2024. Abstr TPS3641.

Hall WA, Karrison TG, McGregor BA, Barata PC, Nagar H, Tang C, Siva S, Morgan TM, Lang J, Glide-Hurst C, Kamran SC, Sundaram KM, Katz SI, Feng FY, McKay RR. NRG-GU012: Randomized phase II stereotactic ablative radiation therapy (SABR) for metastatic unresected renal cell carcinoma (RCC) receiving immunotherapy (SAMURAI) . ASCO (American Society of Clinical Oncology). Poster Presentation. 5/31/2024. Abstr TPS4613.

Jhingran A, Gray HJ, Moughan J, Weidhaas J, Hirschey R, Salehpour MR, Kim J, Kim B, Kim J, Thompson JS, DiSilvestro PA, Backes FJ, Klopp A, Alfieri J, Werner TL, Miller DS, Monk BJ, Small W, Winter K, Gaffney D. Adjuvant Chemotherapy following Concurrent Chemoradiation (CRT) in High-Risk Early-Stage Cervical Carcinoma Patients Following Radical Hysterectomy: Results of NRG Oncology/RTOG 0724/GOG-0724. ASCO (American Society of Clinical Oncology). Oral Presentation. 5/31/2024.   

Rocha Lima C, Yothers G, Jacobs SA, Sanoff HK, Cohen DJ, Guthrie KA, Henry NL, Ganz PA, Kopetz S, Lucas PC, Blanke CD, Hong TS, Wolmark N, Hochster HS, George TJ, Overman MJ. NRG-GI004/SWOG-S1610: Colorectal cancer metastatic dMMR Immuno-Therapy (COMMIT) study: A randomized phase III study of atezolizumab (atezo) monotherapy versus mFOLFOX6/bevacizumab/atezo in the first-line treatment of patients with deficient DNA mismatch repair (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC). ASCO (American Society of Clinical Oncology). Poster Presentation. 6/1/2024. Abstr TPS3632.

Swain SM, Tang G, Puhalla SL, Ganz PA, Henry NL, Cecchini RS, Reid S, Rastogi P, Geyer CE Jr., White J, Clark AS, Haddad TC, Vidal GA, Wolmark N, Mamounas EP. Phase III trial evaluating addition of adjuvant chemotherapy to Ovarian Function Suppression + Endocrine Therapy in premenopausal women with pN0-1, HR+/HER2- breast cancer (BC) and oncotype recurrence score (RS) =25 (OFSET): NRG-BR009. ASCO (American Society of Clinical Oncology). Poster Presentation. 6/2/2024. Abstr TPS612.

White JR, Cecchini RS, Harris EER, Mamounas EP, Stover DG, Ganz PA, Jagsi R, Anderson SJ, Bergom C, Théberge V, El-Tamer M, Zellars RC, Shumway DA, Chen G-P, Julian TB, Wolmark N. NRG-BR007: A phase III trial evaluating de-escalation of breast radiation (DEBRA) following breast-conserving surgery of stage 1, HR+, HER2-, RS ≤18 breast cancer. ASCO (American Society of Clinical Oncology) Poster Presentation. 6/2/2024. Abstr TPS622.

PUBLISHED ARTICLES

Kim IA, Winter KA, Sperduto PW, De Los Santos JF, Peereboom DM, Ogunleye T, Boulter D, Fritz JM, Cho KH, Shin KH, Zoberi I, Choi S, Palmer JD, Liem B, Kim YB, Anderson BM, Thakrar AW, Muanza TM, Kim MM, Choi DH, Mehta MP, White JR. Concurrent Lapatinib With Brain Radiation Therapy in Patients With HER2+ Breast Cancer With Brain Metastases: NRG Oncology-KROG/RTOG 1119 Phase 2 Randomized Trial. Int J Radiat Oncol Biol Phys. 2024 Apr 1;118(5):1391-1401. doi: 10.1016/j.ijrobp.2023.07.019. Epub 2023 Jul 26. PMID: 37506981; PMCID: PMC10811275. Read More.

Liu W, Feng H, Taylor PA, Kang M, Shen J, Saini J, Zhou J, Giap HB, Yu NY, Sio TS, Mohindra P, Chang JY, Bradley JD, Xiao Y, Simone CB 2nd, Lin L. Proton Pencil-Beam Scanning Stereotactic Body Radiation Therapy and Hypofractionated Radiation Therapy for Thoracic Malignancies: Patterns of Practice Survey and Recommendations for Future Development from NRG Oncology and PTCOG. Int J Radiat Oncol Biol Phys. 2024 Feb 21:S0360-3016(24)00297-9. doi: 10.1016/j.ijrobp.2024.01.216. Epub ahead of print. PMID: 38395086. Read More.

Mell LK, Pugh SL, Jones CU, Nelson TJ, Zakeri K, Rose BS, Zeitzer KL, Gore EM, Bahary JP, Souhami L, Michalski JM, Hartford AC, Mishra MV, Roach M 3rd, Parliament MB, Choi KN, Pisansky TM, Husain SM, Malone SC, Horwitz EM, Feng F. Effects of Androgen Deprivation Therapy on Prostate Cancer Outcomes According to Competing Event Risk: Secondary Analysis of a Phase 3 Randomised Trial. Eur Urol. 2024 Apr;85(4):373-381. doi: 10.1016/j.eururo.2023.01.020. Epub 2023 Jan 28. PMID: 36710205; PMCID: PMC10372191. 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 Medical Oncology (ESMO) Gynaecological; Jun 20-22, 2024; Florence, Italy

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

International Society for Quality-of-Life Research (ISOQOL); Oct 13-16, 2024; Cologne, Germany

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

Western Association of Gynecologic Oncologists (WAGO); Jun 12-15, 2024; Seattle, WA

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; submission deadline Apr 9, 2024, 21:00 CET; LBA Jun 6, 2024, 21:00 CET (placeholder required)

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

San Antonio Breast Cancer Society (SABCS); Dec 10-14, 2024; San Antonio, TX; due to publications committee Jun 26, 2024; submission deadline Jul 10, 2024, 11:59 pm CT; LBA Sep 30, 2024, 11:59 pm CT



Society for Immunotherapy of Cancer (SITC); Nov 6-10, 2024; Houston, TX; due to publications committee May 15, 2024; submission deadline Jun 27, 2024