National Colorectal Cancer Awareness Month

NRG Gastrointestinal Colorectal Cancer Portfolio of Clinical Trials 

At the #NRG2023 Winter Meeting in Orlando, we talked with Dr. Thomas George, chair of the NRG Oncology Gastrointestinal Cancer Committee, about the committee's current portfolio of colorectal cancer clinical trials and the focus of developing new treatments for patients with colorectal cancer given the impact of the disease on increasingly younger patients. 

The COBRA and CIRCULATE-US Studies Among ctDNA Trials Featured in Oncology 

The overall publication highlights the COBRA study as one of the first ctDNA colon cancer trials in the United States to open at a national level. Another article within the Oncology issue titled “Clinical Trials in Progress: COBRA” delved into the intricacies and implications of the phase II/III study.  

Additionally, the Oncology issue included an article on the CIRCULATE-US trial titled “Clinical Trials in Progress: CIRCULATE-US”. This article discusses the background of the phase II/III study aimed to investigate minimal residual disease (MRD)-based adjuvant therapy for patients with early-stage colon cancer with intensified and DE-intensified adjuvant approaches, using ctDNA status as a surrogate for MRD-status. 

FORTE Study Update

It’s Colorectal Cancer Awareness Month! 

NRG-CC005/FORTE team has created graphics and captions for distribution across social media platforms – Facebook, Instagram, Twitter, and LinkedIn – for site research staff to use when corresponding, presenting, and following up with participants, patients, and the general public for the NRG-CC005/FORTE study. The graphics include:  



• General information on colorectal cancer  
• General information on clinical trials  
• FORTE Study information  
• Graphics for each state that currently has NRG-CC005 sites activated 

These participant-directed materials have been reviewed and approved by the NCI CIRB. The “Colorectal Cancer Awareness Month” document, along with the CIRB approval letter, are found under the CIRB tab on the CTSU website for NRG-CC005. Before distribution, sites must submit to their local IRB if required per site/local policy. Collaborate with your site communications teams and departments to distribute information on the FORTE study throughout Colorectal Cancer Awareness Month (March 2023).  

NRG Study News and New Protocols Under Development

NRG-BR008 (“HERO”): A Phase III Randomized Trial Seeking to Optimize Use of Radiotherapy in Patients with Early-Stage, Low Risk, HER2-Positive Breast Cancer 

There has long been a movement in radiation oncology to identify patient populations least likely to benefit from adjuvant radiotherapy in order to scale back the use of radiotherapy in those patient populations. In recent years, this effort has begun to be met with success—two examples being “good risk” DCIS patients and favorable-risk older patients with small, node-negative, biologically less aggressive (hormone receptor-positive and HER2-negative) invasive cancers. 

Scaling back radiation among patients who may not stand to benefit significantly spares these patients both potentially unnecessary costs and inconveniences and the toxicity associated with radiation, in addition to reducing the cost of treatment to our healthcare system. It behooves us to empower our patients to make informed decisions by ascertaining the true benefit of radiotherapy, particularly in settings of putatively low oncologic risk. One such setting is patients with early-stage, low risk, HER2-positive breast cancer. While the original trials that cemented radiotherapy as a necessary component after lumpectomy were conducted in an era when HER2-positive breast cancer patients had among the highest recurrence rates, the advent of HER2-directed therapies has now made the prognosis for this subtype of breast cancer among the most favorable.   

Listen to Dr. Lior Braunstein of Memorial Sloan Kettering Cancer Center, the principal investigator for the “HERO” study, explain why he is excited for this potentially paradigm-shifting trial in HER-2 positive breast cancer. 

NRG-GI006, EAY191-N2 (ComboMATCH), and EAY191-N4 (ComboMATCH) Patient Webpage Activations

The EAY191-N2 (ComboMATCH) patient study webpage is now LIVE! Learn more about the NRG trial testing the use of fulvestrant and binimetinib targeted treatment for NF1 mutation in hormone receptor-positive metastatic breast cancer.

www.nrgoncology.org/EAY191-N2

The EAY191-N4 (ComboMATCH) patient study webpage is now LIVE! Learn more about the NRG trial testing the use of the combination of selumetinib and olaparib or selumetinib alone targeted treatment for RAS pathway mutant recurrent or persistent ovarian and endometrial cancers.

www.nrgoncology.org/EAY191-N4





New Protocols Under Development

Reminders

NRG Oncology Survey: Neurotization at time of NSM

The NRG Oncology Breast Cancer Committee leadership would like feedback from breast surgeons at your site regarding the feasibility of developing a protocol: A phase II Randomized Control Trial of Neurotization of the Nipple Areolar Complex at the time of Nipple Sparing Mastectomy and Prosthetic Based Reconstruction.

Neurotization is a surgical technique using a nerve graft to reinnervate the nipple areola complex and restore sensation at the time of nipple sparing mastectomy. There is a large gap in understanding the effectiveness of the procedure and an unmet need exists in determining how the procedure is associated with quality of life. We hypothesize nerve grafting of the nipple areolar complex at the time of nipple sparing mastectomy will restore sensation and improve patient-reported outcomes.

Click here to complete the survey.



NRG Protocol Support Committee (PSC) Column

Circulating Tumor DNA: One of Our Newest Tools for Managing Solid Tumors 

Written by Alison Ivey, RN, MS, MBA, OCN, CCRP from UF Health Cancer Center 

The concept of liquid biopsies for diagnosing and monitoring solid tumors is not new, but it is gaining more traction as a tool in both clinical care and our clinical trials. So, what is a liquid biopsy and how are we leveraging this technology to our patients’ benefit? As we know, biomarker testing is ubiquitous, and we rely on the results to select appropriate therapies for many cancers. Traditionally we use tumor tissue to perform this testing, but this requires the tissue to be located in a relatively safe place for biopsy and always requires an invasive procedure which comes with safety concerns. Alternative options not requiring an invasive procedure are clearly needed and would certainly constitute a major advance.   

Circulating tumor DNA (ctDNA) is comprised of fragments of DNA shed by tumor cells that then enter a bodily fluid and can be detected and quantitated by a simple sampling of the fluid. As the tumor grows or shrinks from therapy, the amount of ctDNA detected by these tests similarly goes up and down, respectively. While ctDNA can be found in urine, stool, mucous, or cerebrospinal fluid, blood drawn peripherally is the most common source for liquid biopsies. This means sampling is non-invasive, quick, accessible, and easily repeatable for serial monitoring during care.  

NRG SDMC Corner

Congratulations to NCI Rectal-Anal Task Force Member, Kathryn Winter 



Kathryn Winter was recently selected to serve as a member on the National Cancer Institute (NCI) Rectal-Anal Task Force. The Rectal-Anal Task Force is one of the 6 NCI/NCTN Gastrointestinal Task Forces, which are advisory to the NCTN Groups and designed to facilitate development of phase 2 and 3 clinical trials in adult rectal and anal cancers. With other leading clinical investigators, biostatisticians, basic and translational scientists, community oncologists, and patient advocates, Kathryn will participate in meetings to review and provide feedback on clinical trial concepts prior to submission to the NCI GI Steering Committee for official review, emphasizing biomarker-driven research and novel approaches that aim to improve the outcomes of patients with rectal and anal cancer. 

Kathryn Winter is the Deputy Director of the NRG Statistics and Data Management Center (SDMC) Philadelphia office and the Senior Director of Statistics at the American College of Radiology. With over 25 years in clinical trials research with NRG Oncology SDMC (and its predecessor), her contributions and expertise continue to play a pivotal role in critical trial design and development. 

Sending Our Best Wishes to Debora Washington 



After over 20 years in Data Management, first with RTOG and then with NRG Oncology, Deb Washington has decided to pursue a promotional opportunity within the American College of Radiology. Deb’s last day with the NRG Oncology Statistics and Data Management Center (SDMC) was on February 17th, 2023. As a nursing professional with a versatile background, she has been a valued resource to the SDMC. We would like to thank Deb for her many years of dedicated service and wish her the best as she takes on this new opportunity.  

NRG at the Miami Breast Cancer Conference

Dr. Wolmark Presents at the 2023 Miami Breast Cancer Conference

NRG Staff News

Christine Rudock to Retire After 53 Years with the NSABP, Nine Years with NRG Oncology

When the lab was closed in the 1980s, Chris took on the role of travel coordinator for NSABP members and continued her graphics work for the next several years. Since 2007, she has been a fulltime member of the publications department staff in Pittsburgh, specializing in graphics, publications database entry, and abstract and manuscript submissions. She is the department expert on the NIHMS publications compliance system for NRG Oncology grant requirements. Chris’ retirement will leave a tremendous vacancy in the publications group: we will miss her talent and dedication.