11 research outputs found

    Treatment Toxicity: Radiation

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    Radiation exposures, both intentional and unintentional, have influence on normal tissue function. Short-term and long-term injuries can occur to all cell systems of both limited and rapid self-renewal potential. Radiation effects can last a lifetime for a patient and can produce complications for all organs and systems. Often invisible at the time of exposure, the fingerprints for cell damage can appear at any timepoint after. Health-care providers will need comprehensive knowledge and understanding of the acute and late effects of radiation exposure and how these interrelate with immediate and long-term care

    Imaging and Neuro-Oncology Clinical Trials of the National Clinical Trials Network (NCTN)

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    Imaging in neuro-oncology clinical trials can be used to validate patient eligibility, stage at presentation, response to therapy, and radiation therapy. A number of National Clinical Trials Network trials illustrating this are presented. Through the Imaging and Radiation Oncology Core’s quality assurance processes for data acquisition and review, there are uniform data and imaging sets for review. Once the trial endpoints have been analyzed and published, the clinical trial information including pathology, imaging, and radiation therapy objects can be moved to a public archive for use by investigators interested in translational science and the application of new informatics tools for trial analysis

    Acquisition and Management of Data for Translational Science in Oncology

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    Oncology clinical trials provide opportunity to advance care for patients with cancer. Bridging basic science with bedside care, cancer clinical trials have brought new and updated scientific knowledge at a rapid pace. Managing subject data in translation science requires a sophisticated informatics infrastructure that will enable harmonized datasets across all areas that could influence outcomes. Successful translational science requires that all relevant information be made readily available in a digital format that can be queried in a facile manner. Through a translational science prism, we look at past issues in cancer clinical trials and the new National Institutes of Health/National Cancer Institute initiative to address the need of database availability at an enterprise level

    Modern Clinical Trials in Radiation Oncology

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    Clinical trials in radiation oncology have improved our translational science and patient care. All patients referred to departments of radiation oncology can be invited to participate in a clinical trial with multiple venues. Study endpoints can include intradepartmental endpoints to improve workflow and patient access as well as interdepartmental clinical translational trials that include the National Clinical Trials Network (NCTN) and industry. The quality of the trial is important to trial outcome and influences interpretation of the results of the study and how the results can be applied to patient care moving forward. Clinical trials in radiation oncology to date have accomplished much, however many important questions remain as patient care matures and systemic therapies become more sophisticated and associated with specific biomarkers and cellular expression products. In this chapter we review the history of clinical trials in radiation oncology and review the current status of the structure of quality assurance in clinical trials. We will review unanswered questions and areas to study in each disease area and how to design strategy for trials to address modern unmet needs in our discipline

    RADIATION THERAPY QUALITY IN CCG/POG INTERGROUP 9961: IMPLICATIONS FOR CRANIOSPINAL IRRADIATION AND THE POSTERIOR FOSSA BOOST IN FUTURE MEDULLOBLASTOMA TRIALS

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    Purpose: Associations of RT deviations and outcomes in medulloblastoma have not been defined well, particularly in the era of reduced-dose CSI and chemotherapy. The aim of this study is to evaluate the quality of RT on CCG/POG 9961 and analyze associations of RT deviations with outcome.Methods and Materials: Major volume deviations were assessed based on the distance from specified anatomical region to field edge. We investigated associations of RT deviations with progression-free survival (PFS), overall survival (OS), and explored associations with demographics and clinical variables.Results: Of the 308 patients who were evaluable for volume deviations, 101 patients (33%) did not have any. Of the remaining 207 patients, 50% had only minor deviations, 29% had only major deviations, and 21% had both minor and major deviations. Of the patients with major deviations, 73% had a single major deviation. The most common major deviation was in the cribriform plate region, followed by the posterior fossa; posterior fossa deviations resulted from treating less than whole posterior fossa. There were no significant differences in PFS or OS between patients with deviations and those without. There was no evidence of associations of deviations with patient age. Conclusions: Approximately one-third of patients had major volume deviations. There was no evidence of a significant association between these and outcome. This lack of correlation likely reflects the current high quality of radiation therapy delivered in COG institutions, our strict definition of volume deviations, and the relatively few instances of multiple major deviations in individual patients. In is noteworthy that the types of posterior fossa volume deviations observed in this study were not adversely associated with outcome. As we move forward, quality assurance will continue to play an important role to ensure that deviations on study do not influence study outcome

    Patterns of relapse from a phase 3 Study of response-based therapy for intermediate-risk Hodgkin lymphoma (AHOD0031): a report from the Children\u27s Oncology Group

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    PURPOSE: The study was designed to determine whether response-based therapy improves outcomes in intermediate-risk Hodgkin lymphoma. We examined patterns of first relapse in the study. PATIENTS AND METHODS: From September 2002 to July 2010, 1712 patients bulk, I-IIAE, I-IIB, and IIIA-IVA with or without doxorubicin, bleomycin, vincristine, etoposide, prednisone, and cyclophosphamide were enrolled. Patients were categorized as rapid (RER) or slow early responders (SER) after 2 cycles of doxorubicin, bleomycin, vincristine, etoposide, prednisone, and cyclophosphamide (ABVE-PC). The SER patients were randomized to 2 additional ABVE-PC cycles or augmented chemotherapy with 21 Gy involved field radiation therapy (IFRT). RER patients were stipulated to undergo 2 additional ABVE-PC cycles and were then randomized to 21 Gy IFRT or no further treatment if complete response (CR) was achieved. RER without CR patients were non-randomly assigned to 21 Gy IFRT. Relapses were characterized without respect to site (initial, new, or both; and initial bulk or initial nonbulk), and involved field radiation therapy field (in-field, out-of-field, or both). Patients were grouped by treatment assignment (SER; RER/no CR; RER/CR/IFRT; and RER/CR/no IFRT). Summary statistics were reported. RESULTS: At 4-year median follow-up, 244 patients had experienced relapse, 198 of whom were fully evaluable for review. Those who progressed during treatment (n=30) or lacked relapse imaging (n=16) were excluded. The median time to relapse was 12.8 months. Of the 198 evaluable patients, 30% were RER/no CR, 26% were SER, 26% were RER/CR/no IFRT, 16% were RER/CR/IFRT, and 2% remained uncategorized. The 74% and 75% relapses involved initially bulky and nonbulky sites, respectively. First relapses rarely occurred at exclusively new or out-of-field sites. By contrast, relapses usually occurred at nodal sites of initial bulky and nonbulky disease. CONCLUSION: Although response-based therapy has helped define treatment for selected RER patients, it has not improved outcome for SER patients or facilitated refinement of IFRT volumes or doses

    Radiotherapy quality assurance report from children\u27s oncology group AHOD0031

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    PURPOSE: A phase 3 trial assessing response-based therapy in intermediate-risk Hodgkin lymphoma mandated real-time central review of involved field radiation therapy (IFRT) and imaging records by a centralized review center to maximize protocol compliance. We report the impact of centralized radiation therapy review on protocol compliance. METHODS AND MATERIALS: Review of simulation films, port films, and dosimetry records was required before and after treatment. Records were reviewed by study-affiliated or review center-affiliated radiation oncologists. A deviation of 6% to 10% from protocol-specified dose was scored as minor ; a deviation of \u3e 10% was major. A volume deviation was scored as minor if margins were less than specified or major if fields transected disease-bearing areas. Interventional review and final compliance review scores were assigned to each radiation therapy case and compared. RESULTS: Of 1712 patients enrolled, 1173 underwent IFRT at 256 institutions in 7 countries. An interventional review was performed in 88% of patients and a final review in 98%. Overall, minor and major deviations were found in 12% and 6% of patients, respectively. Among the cases for which \u3e /=1 pre-IFRT modification was requested by the Quality Assurance Review Center and subsequently made by the treating institution, 100% were made compliant on final review. By contrast, among the cases for which \u3e /=1 modification was requested but not made by the treating institution, 10% were deemed compliant on final review. CONCLUSIONS: In a large trial with complex treatment pathways and heterogeneous radiation therapy fields, central review was performed in a large percentage of cases before IFRT and identified frequent potential deviations in a timely manner. When suggested modifications were performed by the institutions, deviations were almost eliminated
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