Scientific Plan and Structure Established for NRG Oncology
With the submission of the NRG Oncology grant proposal to the National Cancer Institute (NCI) on January 15, the National Surgical Adjuvant Breast and Bowel Project (NSABP), the Radiation Therapy Oncology Group (RTOG), and the Gynecologic Oncology Group (GOG) took the formal step toward becoming the cancer clinical cooperative group NRG Oncology. These three groups have more than 150 years' cumulative experience in conducting practice-defining, multiinstitutional phase II and III trials sponsored primarily by the NCI, as well as a history of undertaking the kind of phase I trials and translational biological studies that will be imperative for future clinical cancer research.
The three legacy groups will continue to carry out NCI-supported trials as independent but collaborative entities through February 2014, with 96 total trials open for patient accrual and 68 trials in development. If all goes as planned, beginning in March 2014, all federal research activities of the merged group will be managed under the auspices of the NRG Oncology Operations Center. The three current chairs, Walter J. Curran, MD; Robert Mannel, MD; and Norman Wolmark, MD, will serve as NRG Oncology principal investigators (PIs) and share equal responsibility for executing the group’s research program.
NRG Oncology Scientific Focus
Internationally recognized investigators populate the leadership and membership of all seven cancer disease site committees encompassed by NRG Oncology. In addition, as the result of the history of its legacy groups, NRG Oncology will bring extensive experience in the conduct of trials not only in the United States but also overseas and in Canada; every NCI-designated cancer center in the United States that conducts clinical research and every lead provincial cancer center in Canada participates in one or more of NRG Oncology’s three legacy groups.
NRG Oncology will focus on the following diseases:
- Adult brain tumors (primary and secondary)
- Head and neck cancer
- Localized and locally advanced lung cancer (both NSCLC and SCLC)
- Breast cancer
- Gastrointestinal cancer (including colorectal and noncolorectal)
- Genitourinary cancer (emphasizing nonmetastatic prostate and bladder)
- Gynecologic cancer (including ovarian, cervix, and endometrial)
We anticipate that the emphasis on these seven disease sites will complement the research missions and clinical trial portfolios of the other groups within the National Cancer Trials Network (NCTN), particularly given NRG Oncology’s unique multidisciplinary strengths in gender-specific cancers, aerodigestive malignancies, and brain tumors. In addition, the group’s mission will focus on patients with localized and intermediate-stage malignancies, an emphasis that is relevant to all seven of NRG Oncology’s cancer disease sites.
NRG Oncology will be uniquely positioned in four specific arenas. The three legacy groups all have a history of practice-defining trials of new multidisciplinary approaches to localized or locally advanced cancer. The new group's mission to improve the lives of cancer patients with these forms of disease through the conduct of high-quality clinical trials is ideally suited to the multimodality research that the new group will conduct.
NRG Oncology will also be especially positioned with regard to the study of clinical trials in breast, gynecologic, and prostate cancers. NRG Oncology’s new configuration will offer new opportunities to examine common pathways of hormonal resistance across these diseases, to develop interactive strategies to overcome hormonal resistance, to study populations at high risk for late disease failure, and to study populations at special risk of developing hormone-responsive malignancies. There are also opportunities to study outcomes beyond survival and disease-free survival (DFS), including sexual functioning and other patient-reported outcomes, as well as comparative-effectiveness research.
In addition, NRG Oncology will be capable of developing and testing innovative advanced radiation oncology technology across the NCTN through its Center for Innovation in Radiation Oncology. This center’s capabilities will allow the group to expand the transformational work conducted in its legacy groups to systematically evaluate new methods of planning and delivering therapeutic radiation; specifically, NRG Oncology will be positioned to design and execute trials that evaluate new radiation oncology approaches to cancer treatment.
Finally, as a result of the landmark translational science results from the group’s legacy committees, the new group's combined efficiencies should result in trials that are at the forefront of such work. NRG Oncology’s trials will emphasize the use of biomarkers to stratify patients with potentially curable malignancies to therapeutic regimens that are designed to truly reflect both the risk of tumor recurrence and the risk of therapy-related toxicities. Efforts currently under way to better understand the biological underpinnings of patient-reported toxicities and to evaluate pathways and mechanisms for interventions will be enhanced once the three legacy groups are united. NRG Oncology’s translational science program will have a strong foundation in tumor and tissue procurement, processing, and storage procedures in conjunction with its biorepository sites in Pittsburgh, San Francisco, and Columbus. Collectively, these laboratories contain more than 797,400 annotated specimens.
Other goals for NRG Oncology include research into rare tumors, mentoring new investigators, expanding NRG membership, improving the enrollment of underserved populations in the group's trials, and offering resources for non-NCTN investigator-initiated trials.