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February 13, 2023

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WEEKLY HIGHLIGHT

NRG Oncology Selects Three Awardees for Health Equity Fellowship Program


Read more here

ACTIVATION

GYNECOLOGIC

NRG-GY012: Activated for Canadian sites, effective February 13, 2023. Activation memo and Canadian PSR documents are now available on CTSU.


CLOSURES

GENITOURINARY

NRG-GU007: Temporary Closure Notice dated February 3, 2023 (posted on CTSU). The trial is temporarily closed to accrual for a protocol-specified toxicity analysis. 

 

HEAD & NECK

NRG-HN005: Temporary Closure Notice dated February 3, 2023 (posted on CTSU). The trial is temporarily closed to accrual while pre-planned interim analysis proceeds. 


TERMINATIONS

GYNECOLOGIC

GOG-0212: Terminated effective January 28, 2023; version date: December 17, 2014 (posted on NRG Oncology)

 

GOG-0273: Terminated effective January 28, 2023; version date: January 21, 2014 (posted on CTSU)


AMENDMENTS

BRAIN

NRG-BN012: Amendment 1; version date: January 20, 2023, and updated OPEN Eligibility checklist posted on CTSU.


GENITOURINARY

NRG-GU009 – Sites in Canada: The NOL and additional forms for amendment 2 are posted on CTSU.

 

GYNECOLOGIC

NRG-GY014: Tazemetostat Action Letter and Amendment 6; version date: January 11, 2023 (posted on CTSU)

 

OTHER PROTOCOL NOTICES

1. ALL DISEASE SITES

NRG-GY022: Actively Recruiting MALE Patients only Read More

 

2. CANCER CONTROL & PREVENTION

NRG-CC005/FORTE: Revised Participant History Questionnaire (posted on CTSU)


NRG-CC005/FORTE: Join the next FORTE site call, an informal discussion on study progress and conduct with the NRG FORTE team, featuring VisionTree representatives. Register today at this link

 

3. GASTROINTESTINAL

NRG-GI008/CIRCULATE-US:Pathologic Staging Table for Eligibility (posted on CTSU)

 

4. GYNECOLOGIC

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

 

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-CC008: Updated Training Slides and Frequently Asked Questions Sheet are now available on the CTSU website.

 

NRG-GY012 and NRG-GY023 – 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-GY018: Clarification/Guidance Memo dated February 6, 2023 (posted on CTSU)

 

5. 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.


NRG-HN009: Reminder! This is a phase II/III study that randomizes patients to curative intent 70 Gy H&N radiation with 100mg/m2 cisplatin every 3 weeks versus 40 mg/m2 cisplatin weekly. The study opened to enrollment on October 27, 2021. Eligibility includes both HPV+ and HPV- patients with primary endpoints of absolute survival and toxicity. 


The recently approved 1st study amendment became effective December 19, 2022. Briefly, eligibility has been expanded and made other valuable improvements to the trial. The protocol documents are a CTSU website and it is open to all US, Canadian and International sites. Please help us enroll.

 

6. 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, March 8, 2023.

DRUG SAFETY UPDATES

Drug Safety updates have been issued for the following studies:

DRUG NAME

PROTOCOL

WEBSITE FOR

SAFETY REPORTS

Cediranib

NRG-GY004

NRG-GY005

NRG-GY012

NRG-GY023


CTSU

CTSU

CTSU

CTSU

Durvalumab

NRG-GY012

NRG-GY023

NRG-HN004

NRG-LU004

RTOG 1308


CTSU

CTSU

CTSU

NRG

CTSU

Ipilimumab

NRG-BN002

NRG-BN007

NRG-GU012

NRG-GY025

NRG-HN005

NRG-HN007

NRG-LU002

NRG

CTSU

CTSU

NRG

CTSU

CTSU

CTSU

Nivolumab

NRG-BN002

NRG-BN007

NRG-HN005

NRG-HN007

NRG-GU012

NRG-GY025

NRG-LU002

NRG

CTSU

CTSU

CTSU

CTSU

NRG

CTSU

NRG Oncology Selects Three Awardees for Health Equity Fellowship Program

NRG Oncology (NRG), a National Cancer Institute (NCI) National Clinical Trials Network (NCTN) group, recently announced that they have named three health equity fellows as a part of the organization’s Health Equity Fellowship Program. Fellowship awardees include Dr. Idalid Franco, Dr. Sophia Kamran, and Dr. Anwaar Saeed. Read the press release


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.


President's Day Holiday Closures

The NRG Oncology Philadelphia East Operations Center, Buffalo SDMC, and San Francisco Biospecimen Bank locations will be closed for the President's Day holiday on Monday, February 20, 2023. All other NRG Oncology offices and bank locations will be open during regular business hours.

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

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 RTOG 0415. Int J Radiat Oncol Biol Phys. 2023 Feb 1:S0360-3016(23)00082-2. doi: 10.1016/j.ijrobp.2023.01.035. Epub ahead of print. PMID: 36736921. 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. 2023 Jan 27:S0302-2838(23)00056-8. doi: 10.1016/j.eururo.2023.01.020. Epub ahead of print. PMID: 36710205. Read more


Please note the following upcoming meeting and abstract submission deadline dates


UPCOMING MEETINGS

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


Miami Breast Cancer Conference; March 2-5, 2023; Miami, FL


Society of Gynecologic Oncology (SGO); Mar 25-28, 2023; Tampa, FL


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


Society of Surgical Oncology (SSO); March 22-25, 2023; Boston, MA


St. Gallen Breast Cancer Conference (SG-BCC); Mar 15-18, 2023; Vienna, Austria

 

UPCOMING ABSTRACT SUBMISSION DEADLINES

American Association of Physicists in Medicine (AAPM); July 23-27, 2023; Houston, TX; due to publications committee Feb 14, 2023; meeting submission deadline Feb 28, 2023 800 pm ET


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)


ESMO Breast Cancer Annual Congress; May 11-13, 2023; Berlin, Germany; due to publications committee Feb 7, 2023; meeting submission deadline Feb 21, 2023 TiP, LBA placeholder 9 pm CET; LBA Apr 12, 2023 9pm CntEurSummrTime


ESMO World Congress on Gastrointestinal Cancer; Jun 28-Jul 1, 2023; Barcelona, Spain; due to publications committee Feb 27, 2023; meeting submission deadline Mar 13, 2023; LBA Jun 15, 2023


International Society for Quality-of-Life Research (ISOQOL); Oct 18-21, 2023; Calgary, AB Canada; due to publications committee Mar 20, 2023; meeting submission deadline Apr 3, 2023; LBA Jul 7, 2023

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