NRG Oncology trial shows neurocognitive function decline but stable quality of life in first year after temozolomide-based chemoradiotherapy for patients with high risk, low-grade gliomas Read more
NRG Oncology Semiannual Meeting - Pre-register today to have your fee waived!
We hope you can join us for the NRG Oncology Semiannual Meeting, January 9-11, 2020, at the Marriott Marquis Houston in Houston, TX. Pre-Registration for this meeting is complimentary for all NRG members who pre-register by the deadline of December 17, 2019. We kindly ask that everyone please pre-register for this meeting before the deadline. Onsite registration will incur a $100 fee. Please note that the fee for the Winter Symposium will not be waived.
Important Information: The meeting schedule has significant changes from past meetings. Please review the preliminary agenda carefully. Click here to see What’s New.
NRG Oncology will be holding a kick-off meeting for NRG-CC008 “
A Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-oophorectomy to Reduce the Risk of Ovarian Cancer Among BRCA1 Carriers [SOROC],” on Friday, January 10 during the CPC workshop at 2:30pm. The protocol is anticipated to activate early 2020 and the session is open to all attendees.
HEAD AND NECK
NRG-HN004: Amendment 4, version date August 21, 2019 and Amendment 5, version date October 4, 2019 (posted on CTSU)
NRG-GI003: Amendment 2, version date October 18, 2019 (posted on CTSU)
HEAD AND NECK
NRG-HN004: The following forms have been updated and should be used immediately. They are posted on CTSU.
The Protocol Specified AE Baseline form has been updated to match the AEs in the protocol. The updated form will also appear in Rave on existing cases.
Therefore, sites are required to complete the form again. This form, version date 19-Nov-2019, is part of the Blank Rave forms.
OPEN Eligibility Checklist 1 has been revised; version date 01-Oct-2019.
Specimen Transmittal form (For Peripheral Blood) has been revised; version date 11-Oct-2019.
Specimen Transmittal form (For Serum samples) has been revised; version date 04-Oct-2019.
Co-Morbidity Scores CRF has been revised; version date 08-Oct-2019.
Data Submission Table (Phase II/III) has been revised.
Adverse Event Guidance document (Phase II/III)
OTHER PROTOCOL NOTICES
NRG-BR002: Reminder - Thanksgiving holiday closure and shipping information for the Kuhn-Hicks Laboratory and MD Anderson Lucci Laboratory (posted on CTSU)
NRG-GY004: Notification of Signature Requirement memo (posted on CTSU)
NRG-GY004: Preparation for Upcoming Database Lock and Analysis memo (posted on CTSU)
NRG-GY005: CEC Whole Blood Shipping Address memo (posted on CTSU)
NRG-GY009: Block Submission Reminder memo (posted on CTSU)
NRG-GY018: NeoGenomics and PPD Laboratories Holiday Closures memo (posted on CTSU)
Form TR for Biospecimens Shipped to NRG Biospecimen Bank-Columbus Read more
Biospecimen Bank-Columbus & SDMC Undergoing Refurbishment Read more
3. HEAD AND NECK NRG-HN004: Please note the UCSD Biorepository will be closed December 22, 2019 to January 6, 2020. We ask that any scheduled collections be performed before or after this period to ensure they can be received and handled properly, even if this means they will be collected out of window.
4. 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, December 11.
DRUG SAFETY UPDATES
Safety updates have been issued for the following study:
WEBSITE FOR SAFETY REPORTS
*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).
NRG Oncology Trial Shows Neurocognitive Function Decline but Stable Quality of Life in First Year After Temozolomide-based Chemoradiotherapy for Patients with High Risk, Low-Grade Gliomas
A secondary analysis of the NRG Oncology clinical trial NRG-RTOG 0424, which initially reported a 73.1% 3-year overall survival rate, shows a decline in neurocognitive function (NCF) for half of the trial participants with high risk, low-grade gliomas (HR-LGGs) up to a year after receiving concurrent chemoradiotherapy with temozolomide. However, the analysis also concluded that on average the quality of life (QOL) of patients either remained stable or improved up to a year following temozolomide-based chemoradiotherapy treatment. These results were presented during the Plenary Session at the Society for Neuro-Oncology’s (SNO) annual meeting in Phoenix, Arizona. Read the press release
NRG Oncology Trial shows that Breast Cancer Recurrence after Lumpectomy and Radiation is Treatable with Localized Radiation without Mastectomy
Approximately 10% of breast cancer patients treated with lumpectomy (breast-conserving surgery [BCS]) and whole-breast radiation (WBI) will have a subsequent in-breast local recurrence of cancer (IBTR) when followed long term. The surgical standard of care has been to perform mastectomy if breast cancer recurs following such breast-preserving treatment. However, a new multi-center study led by Douglas W. Arthur, MD, Chair of the Department of Radiation at the Virginia Commonwealth University/Massey Cancer Center provides the first evidence that partial breast re-irradiation is a reasonable alternative to mastectomy following tumor recurrence in the same breast. Unlike WBI, which exposes the entire breast to high-powered X-ray beams, partial-breast irradiation targets a high dose of radiation directly on the area where the breast tumor is located and thus avoids exposing the surrounding tissue to radiation. Read the press release
CRA and CTN Mentorship Program
Are you a new CRA or CTN within NRG Oncology? Would you like a mentor to help guide you through your new role as a CRA or CTN? Are you an institution in need of more guidance after an audit? The Mentorship Working Group can provide you a mentor! Apply by visiting the NRG Oncology website -- Nurses & CRAS tab -- Mentorship Program. You will find the Mentor Request Form to complete. Instructions on how to submit are on the form. Hope to hear from you soon!
Do you need general information to help you get started in NRG Oncology? The NRG Oncology Mentorship Working Group would like to remind you of a valuable resource. The “Introductory Materials” for CRAs and CTNs is available on the Mentorship Program page of the NRG Oncology website. This online resource was designed to make the introduction to NRG Oncology as smooth as possible by providing information regarding specific processes and contacts to be used when conducting NRG Oncology clinical trials. The information is intended to assist new members in understanding how NRG Oncology functions.
Phase I Program Accepting Applications for Membership
The NRG Oncology Developmental Therapeutics Subcommittees (Phase I and the DT-Radiation Therapy) are accepting site applications for membership to the Phase I program. Applicants will need to submit:
Please complete the application and return the form and necessary materials by December 11 to membership@NRGOncology.org. Previous members will be grandfathered-in. However, a revised application will need to be completed to expand their institutional team into other focused areas. To see the list of previous members click here. These applications can be submitted by December 11 deadline or later.
Thanksgiving Holiday Closures Thanksgiving holiday closure information for the NRG Oncology Operations Offices, Statistics and Data Management Centers (SDMCs), Biospecimen Banks, Serum Bank, and McKesson's Clinical Research Services, is posted on the CTSU and NRG Oncology websites.
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.
Kishan AU, Chu FI, King CR, Seiferheld W, Spratt DE, Tran P, Wang X, Pugh SE, Sandler KA, Bolla M, Maingon P, De Reijke T, Nickols NG, Rettig M, Drakaki A, Liu ST, Reiter RE, Chang AJ, Feng FY, Sajed D, Nguyen PL, Kupelian PA, Steinberg ML, Boutros PC, Elashoff D, Collette L, Sandler HM. Local Failure and Survival After Definitive Radiotherapy for Aggressive Prostate Cancer: An Individual Patient-level Meta-analysis of Six Randomized Trials. Eur Urol. 2019 Nov 9. pii: S0302-2838(19)30774-2. doi: 10.1016/j.eururo.2019.10.008. [Epub ahead of print]PubMed PMID: 31718822. Read More
Please note the following upcoming meeting and abstract submission deadline dates