NRG ONCOLOGY NETWORK GROUP OPERATIONS CENTER

描述（申请人提供）：NRG肿瘤学是一个新成立的NCI国家临床试验网络（NCTN）网络组，通过国家外科辅助乳腺和肠道项目（NSABP），放射治疗肿瘤学组（RTOG），妇科肿瘤组（GOG）其主要愿景是通过开展高质量的NCI支持的多机构临床试验，改善患有局部或局部晚期恶性肿瘤的成年患者的生活。NRG肿瘤学（或NRG）利用三个传统小组的巨大资源、领导力、成员资格和实践定义研究的历史，创建了一个现代化的临床和转化研究组织，能够为以下疾病部位的常见和罕见恶性肿瘤成人患者执行临床和转化研究试验：妇科癌症（包括卵巢癌、子宫颈癌和子宫内膜癌）;脑肿瘤（原发性和继发性）;乳腺癌;胃肠道癌（结直肠癌和非结直肠癌）;泌尿生殖系统癌;头颈癌;和肺癌。NRG将成为领先的网络组，为这些疾病的几个地点定义新的护理标准和科学范式。对于这七个癌症疾病部位，NRG将主要针对早期或中期癌症患者进行试验，测试创新的诊断和治疗方法，包括新的成像，放射肿瘤学和手术方法;新的全身性药物或全身性药物类别与优化的局部区域疗法和现有的全身性疗法的整合，以及使用生物标志物和生物途径定义的方法进行风险分层、研究性治疗分配和临床试验决策。该小组有七个科学核心委员会和四个综合委员会，提供科学支持和制定方案：发展治疗学（DT），转化科学，以患者为中心的成果研究和癌症预防和控制委员会。NRG的DT委员会建立在GOG DT委员会成功招募超过500名患者/年的早期阶段试验导致III期试验的基础上。NRG运营中心与NRG肿瘤统计和数据管理中心（SDMC）和NRG生物储存库完全一致，并将完全符合所有NCI法规，并积极主动地提高其研究的效率和质量。该小组将通过其创新放射肿瘤学中心（CIRO）为其他NCTN网络小组提供放射肿瘤学创新的科学资源。

DESCRIPTION (provided by applicant): NRG Oncology is a newly constituted NCI National Clinical Trials Network (NCTN) network group created through the coordinated efforts of the National Surgical Adjuvant Breast and Bowel Project (NSABP), the Radiation Therapy Oncology Group (RTOG), and the Gynecologic Oncology Group (GOG) with a primary vision of improving the lives of adult patients with localized or locally advanced malignancies through the conduct of high quality NCI-supported multi-institutional clinical trials. NRG Oncology (or NRG) has leveraged the tremendous resources, leadership, membership, and history of practice-defining research of the three legacy groups to create a modern clinical and translational research organization with the capability to execute clinical and translational research trials for adult patients with common and rare malignancies in the following disease sites: Gynecologic Cancer (including Ovarian, Cervix and Endometrial Cancer); Brain Tumors (Primary and Secondary); Breast Cancer; Gastrointestinal Cancers (Colorectal and Non-Colorectal Cancers); Genitourinary Cancer; Head and Neck Cancer; and Lung Cancer. NRG will be the leading network group defining new standards of care and scientific paradigms for several of these disease sites. For these seven cancer disease sites, NRG will primarily conduct trials for patients with early or intermediate stage cancers testing innovative diagnostic and therapeutic approaches, including novel imaging, radiation oncology, and surgical approaches; the integration of novel systemic agents or classes of systemic agents with optimized loco-regional therapies and existing systemic therapies, and the use of biomarker- and biologic pathway-defined approaches to risk stratification, investigational therapy assignment, and clinical trial decision-making. The group has seven scientific core committees and four integrated committees which provide both scientific support and generate protocols: Developmental Therapeutics (DT), Translational Science, Patient-Centered Outcomes Research, and Cancer Prevention and Control Committees. NRG's DT Committee builds on the GOG DT Committee's success in enrolling over 500 patients/year on early phase trials leading to phase III trials. The NRG Operations Center is fully aligned with NRG Oncology Statistical and Data Management Center (SDMC) and the NRG Biorepositories and will be fully compliant with all NCI regulations and proactive in improving the efficiency and quality of its research. The group will serve as a scientific resource for other NCTN network groups for radiation oncology innovation through its Center for Innovative Radiation Oncology (CIRO).