April 23, 2018

NRG Oncology Broadcast archives are accessible from our website at any time. Please bookmark this link for your convenience.


NEW AND UPDATED DATA MANAGEMENT RESOURCES
Visit the NRG Oncology Data Management Resource page for updated documents, dated April 15, 2018, as well as new documents for Lost to Follow-up Guidance and Data Management Contact List.

AMENDMENTS AND UPDATES
BREAST
NSABP B-47: Amendment 8, version date: February 8, 2018 (posted to CTSU

GYNECOLOGIC
GOG-0263: Amendment 5, version date: March 23, 2018 (posted to CTSU)

HEAD & NECK
NRG-HN004: Amendment 1, version date: March 22, 2018 (posted to CTSU)


FORM UPDATES

BREAST
NRG-BR003: An updated Form Entry (with a revised Hormonal Status section) has been implemented in OPEN and an updated Worksheet for Form Entry is posted to the BR003 page on the CTSU website. 

HEAD & NECK
NRG-HN001: The EBV DNA Specimen Transmittal Form has been revised and is available on CTSU.  Use the revised version date: April 16, 2018, immediately.

NRG-HN004:

  • Specimen Transmittal Form (for Peripheral Blood) has been revised and is available on CTSU.  Use the revised version date: April 18, 2018, immediately.
  • New form added- Specimen Transmittal Form (for Serum Samples) is available on CTSUUse version date: April 17, 2018, immediately.

OTHER PROTOCOL NOTICES

COLORECTAL
NRG-GI004: Protocol Pocket Card (posted to CTSU)

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, and NRG-CC004. Space is limited so register now and reserve your seat.  The next webinar training is scheduled for May 9, 2018.
DRUG SAFETY UPDATES AND INVESTIGATOR BROCHURE NOTICES
Safety updates have been issued for the following NRG Oncology studies:

-     
Durvalumab: NRG-HN004
-     Ipilimumab: NRG-GY003
-     Nivolumab: NRG-BN002, NRG-GY002, NRG-GY003
  • For NRG-HN004 safety reports, please see CTSU.
  • For NRG-BN002, NRG-GY002 and NRG-GY003 safety reports, please see the protocol page on the NRG Oncology website for details.

An Investigator’s Brochure notice has been issued for the following studies:

-    Durvalumab: NRG-HN004
-    Ipilimumab: NRG-GY004, BN002

The current version of the Investigator Brochure Documents (Addendum, IB-Summary of Changes) for MEDI4736 (durvalumab) NSC 778709 and (IB-Summary of Changes) for Ipilimumab (BMS-734016; MDX-010 Transfectoma-derived) NSC 732442 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 ( https://ctepcore.nci.nih.gov/OAOP/).  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).

NCI NCTN Navigator Launch - New Resource for Specimens and Data from Cancer Clinical Trials

On April 2, 2018, the NCI launched NCTN Navigator, a new resource for cancer researchers interested in conducting studies using specimens and clinical data collected from cancer treatment clinical trials in the NCI’s National Clinical Trials Network (NCTN) and former NCI Cooperative Group Program.

Navigator provides information regarding specimens, including tumor and blood samples, donated by NCI-sponsored clinical trials patients. Clinical trials included in Navigator are published Phase III studies that evaluated cancer treatments. The NCTN Navigator inventory includes data from more than 80 trials, 50,000 patients, and 600,000 specimens. Biospecimens from over 40 NRG Oncology trials, including trials from our legacy groups, are currently available through Navigator.  Available biospecimens from NRG Oncology trials NOT included in Navigator may be accessed via the procedures detailed on the NRG Oncology website.

Accessing the NCTN Navigator website enables investigators to search the inventory for specimens with specific characteristics. Upon NCI scientific review board approval, appropriation of funds, and agreement execution(s), investigators are granted access to the requested specimens, along with the trial participants’ clinical information, for their research.

Health Disparities Committee Member, Electra Paskett, PhD, Receives Increasing Health Equity Award

Electra Paskett, PhD, a member of the NRG Oncology Health Disparities Committee (HDC), Marion N. Rowley Professor of Cancer Research, and Director of the Division of Cancer Prevention and Control at Ohio State University College of Medicine, was recently awarded the Cancer Prevention Laurel for Increasing Health Equity by the Prevent Cancer Foundation at their Dialogue for Action® annual conference in McLean, VA. The award is presented to an individual or organization for programs or innovations improving cancer prevention and screening in communities in the United States affected by health disparities. Dr. Paskett received this award for her work to reduce health disparities among ethnic minority groups and rural populations.

NRG Oncology’s Publications Policy & Guidelines have recently been updated. The new policy and guidelines document can be found on the NRG Oncology website . Please pay close attention to the changes made regarding manuscripts and abstracts.

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
Chinnaiyan P, Won M, Wen PY, Rojiani AM, Werner-Wasik M, Shih HA, Ashby LS, Michael Yu HH, Stieber VW, Malone SC, Fiveash JB, Mohile NA, Ahluwalia MS, Wendland MM, Stella PJ, Kee AY, Mehta MP. A randomized phase II study of everolimus in combination with chemoradiation in newly diagnosed glioblastoma: results of NRG Oncology RTOG 0913. Neuro Oncol. 2018 Apr 9;20(5):666-673. doi: 10.1093/neuonc/nox209. PubMed PMID: 29126203; PubMed Central PMCID: PMC5892159.  Read more

Hall WA, Pugh SL, Wefel JS, Armstrong TS, Gilbert MR, Brachman DG,Werner-Wasik M, Wendland MM, Brown PD, Chao ST, Roof KS, Robins HI, Mehta MP, Curran WJ Jr, Movsas B. Influence of Residual Disease Following Surgical Resection in Newly Diagnosed Glioblastoma on Clinical, Neurocognitive, and Patient Reported Outcomes. Neurosurgery. 2018 Mar 30. doi: 10.1093/neuros/nyy003. [Epub ahead of print] PubMed PMID: 29618054. Read more

PUBLICATIONS REMINDERS
Please note the following upcoming meeting and abstract submission deadline dates


Upcoming Meetings

American Association of Neurological Surgeons (AANS); Apr 28 - May 2, 2018 New Orleans, LA
American Association for Thoracic Surgery (AATS); Apr 28 - May 1, 2018; San Diego, CA
American College of Radiology (ACR); May 19-23, 2018; Washington, DC
American Radium Society (ARS); May 5-8, 2018; Orlando, FL
American Society of Breast Surgeons (ASBS); May 2-6, 2018; Orlando, FL
American Society of Colon and Rectal Surgeons (ASCRS); May 19-23, 2018; Nashville, TN
American Urology Association (AUA); May 18-21, 2018; San Francisco, CA
Society for Clinical Trials (SCT); May 20-23, 2018; Portland, OR


Upcoming Abstract Submission Deadlines

American Society for Radiation Oncology (ASTRO); Oct 21-24, 2018; San Antonio, TX; Late-breaking Aug 1, 2018
European Society for Medical Oncology (ESMO); Oct 19-23, 2018;Munich, Germany; due to publications committee Apr 25, 2018; meeting abstracts submission deadline May 9, 2018; Late-breaking Sep 17, 2018
International Gynecologic Cancer Society (IGCS); Sep 14-16, 2018; Kyoto, Japan; due to publications committee Apr 27, 2018; meeting abstracts submission deadline May 9, 2018
Society for Neuro-Oncology (SNO); Nov 15-18, 2018; New Orleans, LA; due to publications committee May 21, 2018; meeting abstracts submission deadline June 4, 2018

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