December 5, 2022

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WEEKLY HIGHLIGHT

NRG Oncology Winter Semiannual Meeting registration is open!




 

Register Here

Registration is now open for the NRG Oncology Winter 2023 Meeting to be held both in Orlando and virtually, January 26-28, 2023.


Click here to register today!


(Registrations after January 3rd will incur a late registration fee)


Social Media Ambassadors wanted for #NRG2023

Looking for a few good folks – in-person or virtual! Apply now to be a #NRG2023 Social Media Ambassador for the NRG Oncology Winter Meeting being held in January 26-28, 2023 in Orlando, FL! If interested, please send an e-mail (& please include your Twitter handle) to: shepardm@nrgoncology.org or send us a DM on Twitter by January 16.

AMENDMENTS

GYNECOLOGIC

NRG-GY019: Amendment 2; version date: November 14, 2022 (posted on CTSU)

 

CLOSURES

BREAST

NRG-BR005: Study Termination (Permanent Closure) Notice and Patient Letter. At the request of the NCI, the NRG-BR005 study is terminating/permanently closing, effective December 1, 2022. Please refer to the memorandum, dated December 2, 2022, posted on CTSU for more information.


OTHER PROTOCOL NOTICES

1. ALL DISEASE SITES

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


2. BRAIN

NRG-BN011 (Sites in Canada only): The NOL and additional forms for study are posted on CTSU.

 

3. BREAST

NRG-BR007: Study Overview Webinars are being held on January 17, 2023, at 11am ET and 4pm ET. Please see the memorandum posted on CTSU for more information and for how to register by January 12.


4. CANCER PREVENTION & CONTROL

NRG-CC005/FORTE: December Accrual Updates (posted on CTSU)

 

5. GENITOURINARY

NRG-GU008: A study-specific patient landing page is available on the NRG Oncology website. An updated Participant Brochure is available on the CTSU website (CIRB Approved Documents>Participant Brochure).


6. GYNECOLOGIC

GOG-0210: 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-GY009: In preparation for final analysis, sites are asked to please submit all forms due and address all outstanding queries no later than Friday, December 16th, 2022. Data should be entered in Medidata Rave. Your help at this busy time of year is much appreciated! Please contact Linda Gedeon with any questions regarding data entry for this protocol at gedeonl@nrgoncology.org.


NRG-GY012 and NRG-GY023: BLOOD PRESSURE CUFF SUPPLY IS VERY LIMITED - Please check your supplies on site for any overlooked cuffs prior to ordering. We request that you order only what is absolutely necessary for your site. VWR has asked that orders are limited to two blood pressure cuffs at a time. Please note that it can take up to three business days to receive cuffs after ordering, so plan accordingly. Thank you for your cooperation.  


NRG-GY018: Nearing its accrual goal of 810 patients. Depending on the rate of accrual, the study could close this week. Notification of closure will be provided via NRG Oncology broadcast.

 

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. 

 

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, and NRG/SWOG S1914. Space is limited so register now and reserve your seat. The next webinar training is scheduled for Wednesday, December 14, 2022.

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 UPDATES

INVESTIGATOR'S BROCHURES

Ipatasertib

NRG-GY027

CTSU

X

Trametinib

GOG-0281

CTSU

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).

Reminder about CTSU Website Access

Access to the CTSU Website is managed through the Cancer Therapy Evaluation Program - Identity and Access Management (CTEP-IAM) registration system and ID.me (which incorporates Identity Proofing (IP) and Multi-Factor Authentication (MFA) into the registration process). As of July 8, 2022, all new users must have an active CTEP-IAM account linked with an ID.me account to access the CTSU website. All existing users who had CTEP-IAM accounts prior to July 8, 2022, have until July 2023, to incorporate an ID.me account. If the user’s password needs to be updated, it will force the user to incorporate an ID.me account.


Biospecimen Bank San Francisco Shipping Update

Due to an ongoing strike by some employees at the University of California, the NRG Oncology Biospecimen Bank San Francisco located at UCSF is requesting sites to use Fed Ex for all shipments to the bank until further notice. UPS deliveries to the San Francisco bank cannot be guaranteed during the strike. Please use Federal Express for specimen shipments or delay non-urgent shipments at this time. Please contact the lab at NRGBB@UCSF.EDU prior to resuming shipping by UPS.


NRG Modality Review Policy Available

Modality reviews, defined as central direct review (from various material sources) of information pertaining to the delivery of a treatment component (surgery, radiation therapy, systemic therapy including chemotherapy and hormones, biologics, targeted agents, etc.) remain a staple of NRG Oncology clinical trial conduct. These reviews serve multiple purposes, from confirmation of delivery quality and fidelity for assigned treatment to assurance that newly introduced treatment regimens and their constituent components can be delivered safely and effectively across institutional settings in a multicenter trial. Reviews are part of the NRG Oncology quality assurance program and have historically also provided measures of institutional performance, supplementing information from audits and other oversight processes.


The NRG Modality Review Policy is now posted on the NRG Oncology website.


Request for PILOT Project Applications


Date Issued: December 1, 2022

Submission Due Date: February 17, 2023


NRG Oncology NCORP solicits PILOT projects addressing NRG NCORP Health Disparities Research (HDR) priorities. PILOT projects should generate preliminary data and address feasibility issues to inform the development of a future NCORP concept. The current focus of HDC is to move past simply documenting outcome differences to the development and testing of interventions to remedy them. Applications for this award should address committee priorities including:


  • Focus 1. Development of interventional studies to decrease health disparities among disparity populations, including racial and ethnic minorities, residents in rural geographic areas, and individuals from other medically underserved groups.
  • Focus 2. Testing interventional studies for optimal care of at-risk elderly.
  • Focus 3. Identify optimal access to cancer screening, treatment, symptom management and surveillance among diverse disparity populations.


Please see full details located on the NRG Health Disparities Committee webpage.

PUBLICATIONS REMINDERS

NRG Oncology is pleased to report the scientific articles and abstracts that have appeared or have been presented during the previous week. This publications report includes links, when available, to the article, PubMed abstract, or association abstract.


JOURNAL ARTICLES

Kharofa JR, Yothers G, Kachnic LA, Ajani J, Meyer JE, Augspurger ME, Okawara GS, Garg MK, Schefter TE, Swanson TA, Doncals DE, Kim H, Zaki BI, Narayan S, Lee RJ, Mamon HJ, Schwartz MA, Moughan J, Crane CH. Use of the Toxicity Index in Evaluating Adverse Events in Anal Cancer Trials: Analysis of RTOG 9811 and RTOG 0529. Am J Clin Oncol. 2022 Dec 1;45(12):534-536. doi: 10.1097/COC.0000000000000955. Epub 2022 Nov 22. PMID: 36413683. Read more

 

Please note the following upcoming meeting and abstract submission deadline dates


UPCOMING MEETINGS

American Society of Clinical Oncology (ASCO) GI; Jan 19-21, 2023; San Francisco, CA


American Society of Clinical Oncology (ASCO) GU; Feb 16-18, 2023; San Francisco, CA


ESMO Gynaecological Cancers Annual Congress 2023; Feb 23-24, 2023; Barcelona, Spain


San Antonio Breast Cancer Symposium (SABCS); Dec 6-10, 2022; San Antonio, TX


Society of Surgical Oncology (SSO); Feb 18-20, 2023; San Diego, CA 

 

UPCOMING ABSTRACT SUBMISSION DEADLINES

American Association for Cancer Research (AACR); Apr 14-19, 2023; Orlando, FL; LBA Jan 12, 2023


American Society of Clinical Oncology (ASCO); Jun 2-6, 2023; Chicago, IL; due to publications committee Jan 24, 2023; meeting submission deadline Feb 14, 2023 1159 pm EST; LBA Mar 16, 2023 Noon (EST)


American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium; Feb 16-18, 2023; San Francisco, CA; LBA Dec 13, 2022, Noon (EST)


European Society for Radiotherapy and Oncology (ESTRO); May 12-16, 2023; Vienna, Austria; LBA Jan 18, 2023, 9 pm EST


Society of Surgical Oncology (SSO 2023); Mar 22-25, 2023; Boston, MA; LBA Dec 9, 2022


St. Gallen Breast Cancer Conference (SG-BCC); Mar 15-18, 2023; Vienna, Austria; meeting sub meeting submission deadline Dec 16, 2022


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