May 8, 2023

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WEEKLY HIGHLIGHT

The NRG Oncology 2023 Summer Meeting is now open for registration!

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Summer Meeting Registration is Open!

The NRG Oncology 2023 Summer Meeting is now open for registration! The Meeting will be held 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

AMENDMENTS

GENITOURINARY

NRG-GY025: Amendment 1; version date: April 14, 2023 (posted on CTSU and NRG Oncology)

 

NRG-GY028: Amendment 1; version date: April 6, 2023 (posted on CTSU and NRG Oncology)


CLOSURES & SUSPENSIONS

GASTROINTESTINAL

NRG-GI007: Temporary Closure Notice: April 21, 2023 (posted on NRG Oncology). The trial is temporarily closed to accrual for a protocol-specified toxicity analysis.


OTHER PROTOCOL NOTICES

1. ALL DISEASE SITES

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


2. CANCER PREVENTION & CONTROL

NRG-CC005/FORTE: May 2023 FORTE Newsletter (posted on CTSU)


NRG-CC005/FORTE: Join the next FORTE site call on May 17 at 4pm EDT, an informal discussion on study progress and conduct with the NRG FORTE team, featuring Kaiser Permanente representatives to share about their screening and enrolling processRegister today at this link


3. GASTROINTESTINAL

NRG-GI004/SWOG S1610 (COMMIT): Amendment 9 Overview webinars are being held on May 16 at 10am EDT and 4pm EDT. Please see the memorandum (posted on CTSU) for details and how to register for one of the sessions.

 

4. GENITOURINARY

NRG-GU012 – Sites in Canada: The NOL and additional forms for amendment 1 are posted to CTSU.

 

5. 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 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. 

 

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

 

6. HEAD AND 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 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 June 7, 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)*

Ipilimumab

NRG-BN002

NRG-BN007

NRG-GY025

NRG-GU012

NRG-LU002

NRG

CTSU


CTSU

CTSU



X

Nivolumab

NRG-BN002

NRG-BN007

NRG-GU012

NRG-HN005

NRG-HN007

NRG-LU002

NRG

CTSU

CTSU

CTSU

CTSU

CTSU


Pertuzumab/

trastuzumab/ hyaluronidase-zzxf

NRG-GY026


X

*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. NRG Oncology Patient Study Materials Table Now Live

NRG Oncology just launched a patient materials table on their website showcasing study-specific materials for several active NRG studies. Materials include patient study brochures and patient study webpages. Click here to see the new location for these materials.


2. Drs. George & Markham Receive ASCO Advocacy Champion Honor

Congratulations to Thomas George, MD and Merry Jennifer Markham, MD, both leaders from the University of Florida Cancer Center, for recently being honored by the American Society for Clinical Oncology (ASCO) as Advocacy Champions for exemplifying cancer care advocacy in 2022. Dr. George is the NRG Oncology Gastrointestinal (Colorectal) Cancer Committee Chair and a founding member of the NRG Oncology Communications Committee. Dr. Markham is a current member of the NRG Oncology Ovarian Cancer Subcommittee and one of the original members of the NRG Oncology Communications Committee. Read more about their ASCO Advocacy Champion honors here

 

3. Update to NRG Patient ID Form

We would like to inform you of an update to the Patient ID on NRG Oncology trials opening in the second quarter of 2023. To help preserve patient anonymity, NRG Oncology has made the decision to eliminate the CTEP site ID from the patient identifier. The Patient ID will now contain only the protocol identifier and a 5-digit sequence number. For example, the Patient ID will now be GY040-00001 instead of PA100-GY040-00001. Read the memo.


4. Call for Applications for NRG Committee Leadership Position

Vice Chair, Cancer Control Committee


Application Deadline: May 26, 2023

We are seeking nominations for the position of Vice-Chair of the NRG NCORP Cancer Control committee. The successful candidate will work closely with Dr. Lisa Kachnic in continuing to lead the Cancer Control committee. Candidates for this position should have an active program of funded research and publications focused on the NRG cancer control priorities of improvement or delay in decline of neurocognitive function, reducing gender specific symptoms such as lymphedema and sexual function, and testing therapeutic delivery modifications to improve QoL and cost-effectiveness in localized cancers while maintaining efficacy. Candidates should have a track record of mentorship and a willingness to provide timely consultation to members and liaisons of NRG committees as concepts and protocols are being developed. Click here for more information. 


5. Cisplatin and Carboplatin Drug Shortages

There is currently a shortage of cisplatin nationwide. Please review this memo for a list of NRG studies that involve the use of commercial Cisplatin and/or Carboplatin, and the recommended strategies for enrolling participants in NRG trials involving Cisplatin and/or Carboplatin.

JOURNAL ARTICLES

Bai J, Pugh SL, Eldridge R, Yeager KA, Zhang Q, Lee WR, Shah AB, Dayes IS, D'Souza DP, Michalski JM, Efstathiou JA, Longo JM, Pisansky TM, Maier JM, Faria SL, Desai AB, Seaward SA, Sandler HM, Cooley ME, Bruner DW. Neighborhood Deprivation and Rurality Associated With Patient-Reported Outcomes and Survival in Men With Prostate Cancer in NRG Oncology RTOG 0415. Int J Radiat Oncol Biol Phys. 2023 May 1;116(1):39-49. doi: 10.1016/j.ijrobp.2023.01.035. Epub 2023 Feb 2. PMID: 36736921; PMCID: PMC10106367. Read more.

 

Craig T, Xiao Y, McNulty S, Dawson LA. Insights From Image Guided Radiation Therapy Credentialing for the NRG Oncology RTOG 1112 Liver Stereotactic Body Radiation Therapy Trial. Pract Radiat Oncol. 2023 May-Jun;13(3):239-245. doi: 10.1016/j.prro.2022.11.013. Epub 2022 Dec 26. PMID: 36581199; PMCID: PMC10121829. Read more.

 

Spratt DE, Liu VYT, Michalski J, Davicioni E, Berlin A, Simko JM, Efstathiou JA, Tran PT, Sandler HM, Hall WA, Thompson DJ, Parliament MB, Dayes IS, Correa RJM, Robertson JM, Gore EM, Doncals DE, Vigneault E, Souhami L, Karrison TG, Feng FY. Genomic classifier performance in intermediate-risk prostate cancer: Results from NRG Oncology/RTOG 0126 randomized phase III trial. Int J Radiat Oncol Biol Phys. 2023 May 1:S0360-3016(23)00371-1. doi: 10.1016/j.ijrobp.2023.04.010. Epub ahead of print. PMID: 37137444. Read more.

 

Please note the following upcoming meeting and abstract submission deadlines

 

UPCOMING MEETINGS

American Association for Thoracic Surgery (AATS); May 6-9, 2023; Los Angeles, CA


American College of Radiology (ACR); May 6-10, 2023; Washington, DC


American Society of Clinical Oncology (ASCO); Jun 2-6, 2023; Chicago, IL


ESMO Breast Cancer Annual Congress; May 11-13, 2023; Berlin, Germany


European Society for Radiotherapy and Oncology (ESTRO); May 12-16, 2023; Vienna, Austria


Society for Clinical Trials (SCT); May 21-24, 2023; Baltimore, MD


Western Association of Gynecologic Oncologists (WAGO); Jun 14-17, 2023; Monterey, CA


UPCOMING ABSTRACT SUBMISSION DEADLINES

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


ESMO World Congress on Gastrointestinal Cancer; Jun 28-Jul 1, 2023; Barcelona, Spain; LBA Jun 15, 2023


European Society of Gynaecological Oncology (ESGO); Sep 28-Oct 1, 2023; Istanbul, Turkey; meeting submission deadline May 8, 2023; LBA Aug 7, 2023


European Society for Medical Oncology (ESMO) Congress; Oct 20-24, 2023; Madrid, Spain; meeting submission deadline May 10, 2023, 9pm CntEurSummerTime (CEST); LBA Sep 14, 2023, 9pm CEST


International Gynecologic Cancer Society (IGCS); Nov 5-7, 2023; Seoul, South Korea; meeting submission deadline May 8, 2023, 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

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