June 20, 2023

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WEEKLY HIGHLIGHT

Addition of EBRT to Brachytherapy Did Not Improve Outcomes for Men with Intermediate-Risk Prostate Cancer, Brachytherapy Alone Remains Standard of Care


Read the Press Release

NRG Oncology Summer Meeting Registration is Open!

Join us in celebrating our 10th anniversary at our Summer Meeting in Philadelphia from Thursday, July 20, 2023 - Saturday, July 22, 2023. Sessions will be held in-person and available via streaming unless noted. Additionally, there will be virtual-only sessions on Monday and Tuesday, July 17-18, 2023. Click here to Register Today

 

Hotel Reservation Deadline: June 26, 2023

The hotel reservation deadline for #NRG2023 has been extended until June 26. Please make your hotel reservation here as soon as possible.

 

Summer Symposium - Rare Tumors: Ideas for Implementation of Novel Concepts.

Be sure to register for this informative event happening Thursday, July 20, 2023. 8am – 12pm ET. Presentations will focus on the design, implementation strategies, and progress in clinical trials involving rare tumors. The information presented will span novel clinical trial design with incorporation of novel statistical design and molecular profiling.

See flyer for more information

Social Media Ambassadors wanted for #NRG2023

Apply now to be a #NRG2023 Social Media Ambassador for the NRG Oncology Summer Meeting being held July 20-22, 2023, in Philadelphia! This is the 10th anniversary celebration of NRG Oncology, so what better way to raise your profile than to be posting on your Twitter and/or Instagram accounts about all things #NRG2023? If interested, please send an e-mail

(& please include your Twitter handle) to: communications@nrgoncology.org or

send us a DM on Twitter by July 10.

Join us at the Barnes

NRG Oncology will host our 10th anniversary at the Barnes Foundation on Friday, July 21 from 6-8 PM. Transportation will be provided.

NRG Oncology Memo: Cisplatin & Carboplatin Shortages

Please review the memorandum (posted on the NRG Oncology website) for recommended strategies for enrolling participants in NRG trials involving Cisplatin and Carboplatin.


AMENDMENT

GYNECOLOGIC

NRG-GY019: Amendment 3; version date: May 23, 2023 (posted on CTSU)

 

OTHER PROTOCOL NOTICES

1. ALL DISEASE SITES

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

 

2. GENITOURINARY

NRG-GU010: Updated P4 Decipher Ordering Form and Instructions, dated June 12, 2023, posted to CTSU.

 

3. 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.

 

NRG-GY012: Nearing its accrual target of 288 patients overall. Accrual is projected to complete by July 2023. Please plan future enrollments accordingly.

 

NRG-GY012 and NRG-GY023 – Reminder: BLOOD PRESSURE CUFF SUPPLY IS VERY LIMITED - Please be advised that VWR has a very limited supply of blood pressure cuffs at present. Please check your supplies on site for any overlooked cuffs prior to ordering. Thank you for your cooperation. 

 

NRG-GY020: Reminder that there are mandatory biospecimen submissions at recurrence. Please review protocol Section 10.5.1 and Appendix V for complete information.

 

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

 

4. 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.

 

5. 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, July 12, 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)*

Binimetinib

EAY191-N2


X


Darolutamide

NRG-GU010

CTSU


Ipatasertib

NRG-GY027

NRG-GY028

NRG

NRG


*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).

1. Addition of EBRT to Brachytherapy Did Not Improve Outcomes for Men with Intermediate-Risk Prostate Cancer, Brachytherapy Alone Remains Standard of Care 

Results from the NRG Oncology NRG-RTOG 0232 clinical trial adding external beam radiotherapy (EBRT) to brachytherapy (BT) in men with intermediate-risk prostate cancer indicate that there was no improvement in freedom from progression (FFP) rates for patients. Late adverse events were significantly increased (> 6 months from treatment start) in genitourinary (GU)/gastrointestinal (GI) and analyzed as grade 2+ and as grade 3+ for patients on the trial who received the combination of EBRT and BT (COMBO arm) compared to patients who received BT alone (BT arm). These results, which were recently published in the Journal of Clinical Oncology, suggest that BT should remain the standard of care for this population. Read the press release


2. Register Today: Social Determinants of Cancer Care ~ Lessons Learned and Future Directions

Symposium hosted by the NRG Oncology Health Disparities Committee - Research Implementation Special Interest Group



Social determinants of health play a critical role in cancer care delivery and ultimately cancer outcomes. Furthermore, underrepresented patients have a disproportionately greater burden of cancer, with often higher mortality rates across a wide spectrum of cancer types attributable to bearing more advanced stage and aggressive disease as well as difficulties in access to equitable care, particularly among racial and ethnic minorities, older adults, and rural populations. This symposium will address current challenges related to social determinants of health, cancer care delivery and outcomes that includes innovative interventions to address disparities.

This symposium is being held via Zoom on Friday, June 30, 2023, from 2-3:30pm EDT. Please view the flyer hereClick here to register.


3. ASTRO-NRG Co-Sponsored "ROCKS" Webinar

NRG Oncology worked with ASTRO's "ASTRO Academy" to co-sponsor the Research-Oriented Career Knowledge and Support (ROCKS) web session. This session delved into practical approaches to developing cooperative group trials and increase diversity in clinical trials. Speakers included NRG Oncology Deputy Chair, Mitchell Machtay, MD, and NRG Oncology Early Career & New Investigator Committee Chair, Vinai Gondi, MD. Watch the webinar recording here: Warpwire - ROCKS - ASTRO NGR Developing Cooperative Group Trials and Increasing Diversity

PUBLICATIONS

NRG Oncology is pleased to report the scientific articles that appeared during the previous week. This publications report includes the link to these articles.

 

JOURNAL ARTICLES

Michalski JM, Winter KA, Prestidge BR, Sanda MG, Amin M, Bice WS, Gay HA, Ibbott GS, Crook JM, Catton CN, Raben A, Bosch W, Beyer DC, Frank SJ, Papagikos MA, Rosenthal SA, Barthold HJ, Roach M 3rd, Moughan J, Sandler HM. Effect of Brachytherapy With External Beam Radiation Therapy Versus Brachytherapy Alone for Intermediate-Risk Prostate Cancer: NRG Oncology RTOG 0232 Randomized Clinical Trial. J Clin Oncol. 2023 Jun 14:JCO2201856. doi: 10.1200/JCO.22.01856. Epub ahead of print. PMID: 37315297. Read more.

 

Movsas B, Rodgers JP, Elshaikh MA, Martinez AA, Morton GC, Krauss DJ, Yan D, Citrin DE, Hershatter BW, Michalski JM, Ellis RJ, Kavadi VS, Gore EM, Gustafson GS, Schulz CA, Velker VM, Olson AC, Cury FL, Papagikos MA, Karrison TG, Sandler HM, Bruner DW. Dose-Escalated Radiation Alone or in Combination With Short-Term Total Androgen Suppression for Intermediate-Risk Prostate Cancer: Patient-Reported Outcomes From NRG/Radiation Therapy Oncology Group 0815 Randomized Trial. J Clin Oncol. 2023 Jun 10;41(17):3217-3224. doi: 10.1200/JCO.22.02389. Epub 2023 Apr 27. PMID: 37104723; PMCID: PMC10256387. Read more.

 

Krauss DJ, Karrison T, Martinez AA, Morton G, Yan D, Bruner DW, Movsas B, Elshaikh M, Citrin D, Hershatter B, Michalski JM, Efstathiou JA, Currey A, Kavadi VS, Cury FL, Lock M, Raben A, Seaward SA, El-Gayed A, Rodgers JP, Sandler HM. Dose-Escalated Radiotherapy Alone or in Combination With Short-Term Androgen Deprivation for Intermediate-Risk Prostate Cancer: Results of a Phase III Multi-Institutional Trial. J Clin Oncol. 2023 Jun 10;41(17):3203-3216. doi: 10.1200/JCO.22.02390. Epub 2023 Apr 27. PMID: 37104748. Read more.

 

Please note the following upcoming meeting and abstract submission deadlines


UPCOMING MEETINGS

ESMO World Congress on Gastrointestinal Cancer; Jun 28-Jul 1, 2023; Barcelona, Spain


UPCOMING ABSTRACT SUBMISSION DEADLINES

American Society for Radiation Oncology (ASTRO); Oct 1-4, 2023; Chicago, IL; LBA Jul 12, 2023


European Society of Gynaecological Oncology (ESGO); Sep 28-Oct 1, 2023; Istanbul, Turkey; LBA Aug 7, 2023


European Society for Medical Oncology (ESMO) Congress; Oct 20-24, 2023; Madrid, Spain; LBA Sep 14, 2023, 9pm CEST


International Gynecologic Cancer Society (IGCS); Nov 5-7, 2023; Seoul, South Korea; Abstract & Film; TiP LBA, Aug 21, 2023


International Society for Quality-of-Life Research (ISOQOL); Oct 18-21, 2023; Calgary, AB Canada; LBA Jul 7, 2023


San Antonio Breast Cancer Symposium (SABCS); Dec 5-9, 2023; meeting submission deadline Jul 10, 2023; LBA Sep 30, 2023, 11:59 PM CT



Society for NeuroOncology (SNO); Nov 15-19, 2023; Vancouver, Canada; LBA Sep 4, 2023, 5:00 PM EDT

 

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