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September 2023

communications@nrgoncology.org

www.nrgoncology.org

Welcome to the NRG Oncology eNewsletter

If you have a suggestion or would like to submit content to our Communications team, please email communications@nrgoncology.org

Gynecologic Cancer Awareness Month

NRG-GY026: Testing the addition of trastuzumab or trastuzumab/pertuzumab to the usual chemotherapy for HER2 positive uterine serous or carcinosarcoma

Currently enrolling patients, NRG-GY026 is a randomized phase II/III study evaluating the efficacy of trastuzumab or hyaluronidase-oysk (HERCEPTIN HYLECTA) and pertuzumab, trastuzumab or hyaluronidase-zzxf (PHESGO) in combination with paclitaxel/carboplatin in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma.

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Study PI, Dr. Britt Erickson discusses the NRG-GY026 study.

Prostate Cancer Awareness Month

Current NRG Oncology Prostate Cancer trials:


NRG-GU008 / INNOVATE Study: Randomized Phase III Trial Incorporating Apalutamide and Advanced Imaging into Salvage Treatment for Patients with Node-Positive Prostate Cancer After Radical Prostatectomy (INNOVATE*) *INtensifying treatment for NOde positive prostate cancer by VArying the hormonal ThErapy. Visit the INNOVATE Study patient webpage

 

NRG-GU009 / PREDICT-RT Study: Parallel Phase III Randomized Trials for High Risk Prostate Cancer Evaluating De-Intensification for Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk With Radiation.

Visit the PREDICT-RT Study patient webpage and watch the video by Study PI, Dr. Paul Nguyen, explaining this study for patients with high-risk prostate cancer.

 

NRG-GU010

Parallel Phase III Randomized Trials Of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification And Intensification Clinical Trial Evaluation (Guidance). Visit the NRG-GU010 Study patient webpage.


NRG-GU011 / NRG PROMETHEAN Study

A Phase II Double-Blinded, Placebo Controlled Trial of Prostate Oligometastatic Radiotherapy with or without Androgen Deprivation Therapy in Oligometastatic Prostate Cancer. Visit the NRG PROMETHEAN Study patient webpage and watch the interview with Study PI, Dr. Bridget Koontz discussing this prostate cancer study for men who were treated with either surgery or radiation, and whose cancer has returned and is visible on a PET scan.


NRG-GU012 / The SAMURAI Study

A Randomized Phase II Stereotactic Ablative Radiation Therapy (SABR) For Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (Samurai). Visit the SAMURAI Study patient webpage and watch the interview with Study PI, Dr. William Hall.

Importance of PROs in Clinical Trials


During the #NRG2023 Meeting in Philadelphia, we asked Ron Chen, MD (PCOR Committee Vice Chair), and Stephanie Pugh, PhD (NRG NCORP SDMC Deputy Director) to discuss the importance of Patient-Reported Outcomes in Clinical Trials. Watch the interview here!

NRG Oncology Protocol News

Recent Activations

NRG-BR009/OFSET: A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression and Endocrine Therapy in Premenopausal Patients with pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score of ≤ 25. Read more

 

NRG-GY031: A Phase IB Study of combination ATR (M1774) and BET Inhibition (ZEN003594) to Exploit ARID1A Loss in Recurrent ovarian and endometrial cancer. (Open to patient entry for NRG Oncology Participating Institutions for Safety Lead-ins.) Read more

New Protocols Under Development

The NRG Oncology chart of new protocols under development includes the study’s disease site, title, Principal Investigator, and any comments pertaining to the study’s anticipated activation.


The updated listing as of August 31, 2023 can be found here.

Annual Call for NRG Oncology Committee Membership Applications

Are you interested in serving on an NRG Oncology committee? NRG Oncology depends on its members to advance its mission. Our members help drive our research, develop protocols, contribute to our science, and so much more. If you are interested in serving on an NRG Oncology research committee, or if you are a member who had previously served on a committee and would like to re-engage please consider applying by following the instructions in the 2023 NRG ONCOLOGY GENERAL AND CORE COMMITTEES APPLICATION FORM and submitting a complete application.


All applications must be submitted by midnight October 2, 2023. 


Current committee members do not need to reapply.


The next call for applications for core and general committees will occur in the Fall 2024.

Reminder to review CTEP IAM account and NRG roster status

NRG Oncology is now soliciting applications for cancer disease site committees, non-disease site committees, and scientific core committees until October 2, 2023, 11:59pm ET. If you are interested in applying for committee membership, now is the time to review your CTEP IAM account and NRG roster status to ensure you meet the requirement for having an active status on the roster at an active NRG member site.

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Protocol Support Committee (PSC) Column

Pharmaceutical Management Branch (PMB) AURORA Updates

Written by: Kayla Dye, PharmD, Senior Clinical Research Pharmacist, CTEP/PMB/DCTD/NCI

AURORA is the NCI’s innovative and centralized agent inventory management system. Most of the modules within AURORA launched in January 2023 and have successfully been used by thousands of clinical trial sites since the launch. Gaining access to AURORA requires users to obtain credentials required for access to secure NCI Clinical Oncology Research Enterprise (CORE) systems. Access to certain modules within AURORA is based on your user role determined by your clinical trial site.

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NRG Oncology News

NRG Oncology presentations at ASTRO Annual Meeting

NRG Oncology will be well represented at the upcoming ASTRO Annual Meeting, being held in San Diego, October 1-4, 2023. The Master Class, “Beyond RTOG v2.0: The First Ten Years of NRG Oncology and Paying it Forward for Many Years Ahead” will be held on Sunday, October 1st and is being chaired by Drs. Quynh Le and Mitch Machtay. Session speakers are Drs. Kristin Higgins and Vinai Gondi. In addition, there will be two plenary sessions featuring NRG-CC003 and NRG-RTOG 0920. The flyer listing all NRG Oncology research being prestented at ASTRO is posted on the NRG Oncology website.

Secondary Analysis of NRG Oncology-RTOG 0617 Presented at IASLC 2023: 5-Year Long-Term Outcomes by Radiation Technique for Locally Advanced Non-Small Cell Lung Cancer

The secondary analysis findings were recently presented at the 2023 IASLC World Conference on Lung Cancer (WCLC) in Singapore and were additionally selected for inclusion in the conference’s Press Program. Read the Press Release

NRG-GI007 Oncolys BioPharma Press Release

Oncolys Biopharma (“Oncolys”) recently announced that the safety endpoint of the initial safety cohort of NRG-GI007 has been met. Read the press release issued by Oncolys, “Meeting of Safety Endpoint in the Initial Safety Cohort of the Phase I Clinical Trial for Telomelysin ™(OBP-301)-Chemoradiation Combination Therapy (NRG-GI007)” here: Press Release from Oncolys

FORTE Study Update

Thanks to your recruitment efforts, FORTE has accrued over 900 participants! Keep up the good work!

FORTE Workshop at #NRG10!

The NRG Summer Meeting was held in-person and virtually in Philadelphia in July 2023, where NRG Oncology celebrated our 10th anniversary. FORTE was represented by NRG Oncology staff, study leadership, and clinical research professionals working alongside NRG-CC005.

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