August 26, 2019
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ACTIVATIONS

GYNECOLOGIC

NRG-GY019: Activation effective August 26, 2019; version date: May 29, 2019 (posted on  CTSU)


TERMINATION

CANCER PREVENTION & CONTROL

NRG-CC001: Study Termination: August 26, 2019. See study memo on the NRG Oncology Website.


FORM UPDATES

LUNG

NRG-LU005: Revised Quality of Life forms have been posted on CTSU. Correct QOL forms can be accessed at these locations: 

  • NRG-LU005 > CIRB Documents > Amendment Reviews > Participant Questionnaire > Support Documents # 1-6 posted 8/9/2019
  • NRG-LU005 > CIRB Documents > Amendment Reviews > Participant Questionnaire > Support Documents #1-4 posted 6/10/2019
  • NRG-LU005 > CIRB Documents > Initial Reviews > Support Documents #12-13 posted 5/28/2019

OTHER PROTOCOL NOTICES

1. GYNECOLOGIC

NRG-GY005: CEC Whole Blood Shipping Address memo (posted on  CTSU)

 

NRG-GY009: Block Submission Reminder memo (posted on  CTSU)

 

NRG-GY018: Kit Ordering memo (posted on  CTSU)

 

Form TR for Biospecimens Shipped to NRG Biospecimen Bank-Columbus  Read more

 

Biospecimen Bank-Columbus & SDMC Undergoing Refurbishment Read more

 
2. LUNG

NRG-LU003: The Spanish-translated consent forms and CIRB approvals of the forms are available on the CTSU website.

 

3. 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 Wednesday, September 11, 2019.

 

 

DRUG SAFETY UPDATES AND INVESTIGATOR BROCHURE (IB) NOTICES

Safety updates and IB Notices have been issued for the following studies:

 

DRUG NAME

PROTOCOL

WEBSITE FOR SAFETY REPORTS

IB*

Ipilimumab

NRG-BN002

NRG

 

Nivolumab

NRG-BN002

NRG

 

Pembrolizumab

NRG-HN003
NRG-GY016

CTSU
CTSU

X
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 (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).

 

LABOR DAY HOLIDAY CLOSURES

The NRG Oncology Operations Offices, Statistics and Data Management Centers (SDMCs), Biospecimen Banks, Serum Bank, and McKesson's Clinical Research Services, will be closed on Monday, September 2nd in observance of Labor Day. The Philadelphia East Operations will also be closed on Friday, August 30. More information about these closures and shipping information for the banks is posted on the NRG Oncology website under "News."

 

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

Mell LK, Shen H, Nguyen-Tan PF, Rosenthal DI, Zakeri K, Vitzthum LK, Frank SJ, Schiff PB, Trotti A, Bonner JA, Jones CU, Yom SS, Thorstad WL, Wong S, Shenouda G, Ridge JA, Zhang QE, Le QT. Nomogram to Predict the Benefit of Intensive Treatment for Locoregionally Advanced Head and Neck Cancer. Clin Cancer Res. 2019 Aug 16. pii: clincanres.1832.2019. doi: 10.1158/1078-0432.CCR-19-1832. [Epub ahead of print] PubMed PMID: 31420360.   Read More

Randall ME, Filiaci V, McMeekin DS, von Gruenigen V, Huang H, Yashar CM, Mannel RS, Kim JW, Salani R, DiSilvestro PA, Burke JJ, Rutherford T, Spirtos NM, Terada K, Anderson PR, Brewster WR, Small W, Aghajanian CA, Miller DS. Phase III Trial: Adjuvant Pelvic Radiation Therapy Versus Vaginal Brachytherapy Plus Paclitaxel/Carboplatin in High-Intermediate and High-Risk Early Stage Endometrial Cancer. J Clin Oncol. 2019 Jul 20;37(21):1810-1818. doi: 10.1200/JCO.18.01575. Epub 2019 Apr 17. PubMed PMID: 30995174. Read More

 

PUBLICATIONS REMINDERS

Please note the following upcoming meeting and abstract submission deadline dates

Upcoming Meetings

American Society for Radiation Oncology (ASTRO); Sep 15-18, 201 9; Chicago, IL

European Society for Medical Oncology (ESMO); Sep 27-Oct 1, 2019; Barcelona, Spain

International Gynecologic Cancer Society (IGCS); Sep 19-20, 2019; Rio de Janeiro, Brazil

International Society for Quality of Life Research (ISOQOL); Oct 20-23, 2019; San Diego, CA

Upcoming Abstract Submission Deadlines

American Society of Clinical Oncology (ASCO) GI; Jan 23-25, 2020; San Francisco, CA; due to publications committee Sep 17, 2019; meeting submission deadline Oct 1, 2019

San Antonio Breast Cancer Symposium (SABCS); Dec 10-14, 2019; San Antonio, TX; LBA Aug 30, 2019

NRG Oncology is proud to be an active participant of #CancerMoonShot.
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