National Cancer Institute (NCI)
The purpose of this Notice is to announce the NCI's intention to issue a Funding Opportunity Announcement (FOA) that invites applications for Radiation Oncology-Biology Integration Network (ROBIN) Centers. The cadre of ROBIN Centers created through this FOA will establish an agile and effective national radiation oncology network infrastructure that collectively address critical hypothesis- based translational research knowledge gaps on the biological basis of responses in cancer patients who undergo radiation treatments.
This Notice is being provided to allow potential applicants sufficient time to develop a responsive, multicomponent ROBIN proposal. The FOA is expected to be published in June 2021 with an expected application due date in November 2021. Details of the planned pre-application webinar will be announced in the Guide after publication of the FOA.
The FOA will utilize the U54 (Specialized Center-Cooperative Agreements) activity code to support:
• Longitudinal collection of clinically annotated research biospecimens, biomarkers, and multimodal data from small cohorts of cancer patients prior to (e.g., baseline), during (e.g., on-treatment), and after radiation therapy. The choice of specific cancer type(s) and characterization plan should be justified based on feasibility, information yield, and likelihood to have impact on significant challenges in radiation oncology to inform the design, and/or health-related outcomes of future clinical trials;
• Circumscribed research projects designed to leverage biospecimens, biomarkers, and integrate multiscale, multimodal data obtained from these patient cohorts to test a central hypothesis on mechanistic interactions and biologic consequences of radiation treatment in the specific focus area that thematically defines the Center;
• Multidisciplinary workforce development through cross-training and stakeholder engagement in both pre-clinical and translational research to best inform clinical radiation oncology studies, including leveraging data science and informatics approaches.
The ROBIN Centers will include human subjects research designated as clinical trials research. The awards we expect to make will support multidimensional, data-dense, small cohort characterization trials of patients receiving standard of care radiation either alone or in a combined modality treatment setting for the cancer(s) of study and will not support clinical trials designed to test for safety or effectiveness of combination treatments. Future clinical trials building on ROBIN Center findings may be supported in a variety of ways, including, but not limited to NCI's Experimental Therapeutics Clinical Trials Network or National Clinical Trials Network.
Collectively, data generated through the ROBIN Centers have potential to set the stage for the cancer research community to move towards a new era of personalized radiation oncology where treatment planning may be optimized in novel ways based on an individual patient’s unique biological signatures to reliably predict radiation-combined modality responses, overcome treatment failure, and mitigate normal tissue toxicities.
At the foundation of each proposed ROBIN Center will be a molecular characterization trial(s) focused on longitudinal collection of biospecimens and multimodal data from a small cohort(s) of patients prior to-, while on-treatment, and after radiotherapy. A successful ROBIN Center will create a research environment with a minimum of two well developed and interrelated research projects with specific aims that directly mesh with the scope and design of the molecular characterization trial. All proposed research projects must be planned with clear potential to longitudinally monitor and assess radiation response dynamics in human patients with the goal of developing a holistic understanding of treatment ramifications in the cancer type(s) and focus area that defines the Center. Priority research project areas for ROBIN Centers include, but are not limited to:
• Factors that demarcate characteristics (e.g., functional -omics), heterogeneity, and mechanistic basis of radiation treatment responses in tumor, proximal normal tissue, and distal organ sites;
• Collection and convergence of data-dense, high-content, multimodal approaches that describe multi-scale longitudinal (e.g., before, on-treatment, and after) radiation response dynamics, which have potential to inform treatment planning or trial design;
• Distinction of radiation therapy-specific biological responses from combined modality treatments (e.g., chemoradiation) including mechanistic basis for radiation to induce druggable targets and/or use in synthetic lethality approaches;
• Mechanisms of adaptation to radiation treatment that underlie emergence of resistance, treatment response (success or failure);
Multi-PI and/or multiple institutional applications will be encouraged to maximize the potential of team science efforts and combine capabilities that might be necessary to fulfill the need for highly specialized multidisciplinary research that lies at the intersection of radiation oncology, cancer/radiation biology, and medical physics. Consistent with this, each ROBIN Center shall contain a required Cross-Training Core, designed to foster workforce development and a culture of scientific cross-pollination.
It is anticipated that molecular characterization approaches based on tissue procurement from patients over the course of radiation therapy will be accompanied by orthogonal non-invasive approaches (e.g., imaging, circulating markers, sensor technologies). Studies may be complemented by correlative radiation treatment experiments in established pre-clinical models (e.g., canine, PDX, GEMMs) that directly support testing the overall hypothesis that guides a respective ROBIN Center. Likewise, pre-clinical models with demonstrated relevance to radiation treatment may be leveraged in the initial project period to refine technological innovation and capabilities planned for characterization studies with patient samples, and/or be used to distinguish combined modality responses. Some applicants may offer an arrangement where the putative ROBIN Center’s home institution provides additional complementary support in the form of allied clinical trials, existing cores, and/or industry, national lab partnerships.
$4.8M per year for five years
$1.6M total cost
93.393, 93.394, 93.395, 93.396, 93.399
Applications are not being solicited at this time.
Please direct all inquiries to:
Michael Graham Espey, Ph.D.
Radiotherapy Development Branch
Radiation Research Program, DCTD
National Cancer Institute (NCI)