Identifying Barriers to Accrual in Radiation Oncology Randomized Trials

Laba, Joanna; Senan, Suresh; Schellenberg, Devin; Harrow, Stephen; Mulroy, Liam; Senthi, Sashendra; Swaminath, Anand; Kopek, Neil; Pantarotto, Jason; Pan, Li; Pearce, Andrew; Warner, Andrew; Louie, Alexander V.; Palma, David A.

doi:10.3747/co.24.3662

Cited by 13 publications

(11 citation statements)

References 11 publications

(11 reference statements)

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“…In the absence of Canadian guidelines outlining the role of SBRT for OM breast cancer, it is the ideal time to clarify uncertainties in the field with a clinical trial. Among Radiation Oncologists, it has recently been demonstrated that a key barrier to trial accrual is a perceived lack of equipoise between the study arms . The key physician stakeholders in the management of OM breast cancer are the medical oncologists (MOs).…”

Section: Percent Of Medical Oncologists Comfortable Referring Oligomementioning

confidence: 99%

“…Among Radiation Oncologists, it has recently been demonstrated that a key barrier to trial accrual is a perceived lack of equipoise between the study arms. 3 The key physician stakeholders in the management of OM breast cancer are the medical oncologists (MOs). They are the individuals who decide when to and which systemic therapy to administer to this patient population.To best design studies that correspond to their understanding of where clinical equipoise lies, their opinions regarding SBRT for their patients must be understood.…”

mentioning

confidence: 99%

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Attitudes and beliefs toward the use of stereotactic body radiotherapy in oligometastatic breast cancer: A commentary on a survey of Canadian Medical Oncologists

et al. 2019

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Stereotactic body radiotherapy (SBRT) is a highly ablative local therapy which has emerged as part of the treatment paradigm for patients with oligometastatic (OM) breast cancer (defined by 5 or fewer sites). This patient group has demonstrated improved prognosis in some cases and may therefore, benefit from aggressive local treatment. The role of upfront SBRT in newly diagnosed OM breast cancer in addition to systemic therapy is not clear, yet it is being increasingly utilized within the oncology community. The Canadian medical system is an ideal platform in which to investigate SBRT into the OM breast cancer setting, as it is not routinely implemented across centers at this time, as there is potential for robust collaboration between oncologists in the small community to investigate SBRT, and there is limited financial or industry motivation for early SBRT uptake compared with other countries. It is critical therefore to define the optimal patient population and scenarios for which SBRT should be investigated, as well as offered in the interim to Canadian patients. We therefore conducted a survey of Canadian Medical Oncologists, the primary physicians and gatekeepers of patients with OM breast cancer, to characterize their beliefs, opinions, and areas of controversy in the use of SBRT for OM breast cancer.

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Section: Percent Of Medical Oncologists Comfortable Referring Oligomementioning

confidence: 99%

mentioning

confidence: 99%

Attitudes and beliefs toward the use of stereotactic body radiotherapy in oligometastatic breast cancer: A commentary on a survey of Canadian Medical Oncologists

et al. 2019

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“…A second obstacle is that there are difficulties with patient accrual in randomized controlled trials [ 15 ]. Currently, most studies on oligo-metastases are retrospective studies, with small groups of patients.…”

Section: Introductionmentioning

confidence: 99%

Prediction of Microscopic Metastases in Patients with Metachronous Oligo-Metastases after Curative Treatment of Non-Small Cell Lung Cancer: A Microsimulation Study

Wolff

Alberts

Kastelijn

et al. 2021

Cancers

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Metachronous oligo-metastatic disease is variably defined as one to five metastases detected after a disease-free interval and treatment of the primary tumour with curative intent. Oligo-metastases in non-small cell lung cancer (NSCLC) are often treated with curative intent. However additional metastases are often detected later in time, and the 5-year survival is low. Burdensome surgical treatment in patients with undetected metastases may be avoided if patients with a high versus low risk of undetected metastases can be separated. Because there is no clinical data on undetected metastases available, a microsimulation model of the development and detection of metastases in 100,000 hypothetical stage I NSCLC patients with a controlled primary tumour was constructed. The model uses data from the literature as well as patient-level data. Calibration was used for the unobservable model parameters. Metastases can be detected by a scheduled scan, or an unplanned scan when the patient develops symptoms. The observable information at time of detection is used to identify subgroups of patients with a different risk of undetectable metastases. We identified the size and number of detected oligo-metastases, as well as the presence of symptoms that are the most important risk predictors. Based on these predictors, patients could be divided into a low-risk and a high-risk group, having a model-based predicted probability of 8.1% and 89.3% to have undetected metastases, respectively. Currently, the model is based on a synthesis of the literature data and individual patient-level data that were not collected for the purpose of this study. Optimization and validation of the model is necessary to allow clinical usability. We describe the type of data that needs to be collected to update our model, as well as the design of such a validation study.

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“…A second obstacle is that there are difficulties with patient accrual in randomized controlled trials. (14) Currently, most studies on oligo-metastases are retrospective studies, with small groups of patients.…”

Section: Introductionmentioning

confidence: 99%

Prediction of microscopic metastases in patients with metachronous oligo-metastases after curative treatment of Non-Small Cell Lung Cancer

Wolff

Alberts

Kastelijn

et al. 2019

Preprint

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Metachronous oligo-metastatic disease is variably defined as one to five metastases detected after a disease-free interval and treatment of the primary tumour with curative intent. Oligo-metastases in non-small cell lung cancer (NSCLC) are often treated with curative intent. However additional metastases are often detected later in time, and 5-year survival is low. Burdensome surgical treatment in patients with undetected metastases may be avoided if patients with high versus lowrisk of undetected metastases can be separated.Because there is no clinical data on undetected metastases available, a microsimulation-model of the development and detection of metastases in 100.000 stage I NSCLC patients with a controlled primary tumour was constructed. The model uses data from the literature as well as patient-level data. Calibration was used for unobservable model parameters. Metastases can be detected by a scheduled scan, or an unplanned scan when the patient develops symptoms. The observable information at time of detection is used to identify subgroups of patients with different risk of undetectable metastases. We identified size and number of detected oligo-metastases, as well as presence of symptoms to be the most important risk predictors. Based on these predictors, patients could be divided into a low-risk and a high-risk group having a model-based predicted probability of 8.1% and 89.3% to have undetected metastases, respectively. Currently, the model is based on a synthesis of literature data and individual patient-level data that was not collected for the purpose of this study. Optimisation and validation of the model is necessary to allow clinical usability. We describe the type of data that needs to be collected to update our model, as well as the design of such validation study.

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Identifying Barriers to Accrual in Radiation Oncology Randomized Trials

Abstract: Background Data about factors driving accrual to radiation oncology trials are limited. In oncology, 30%-40% of

Cited by 13 publications

References 11 publications

Attitudes and beliefs toward the use of stereotactic body radiotherapy in oligometastatic breast cancer: A commentary on a survey of Canadian Medical Oncologists

Attitudes and beliefs toward the use of stereotactic body radiotherapy in oligometastatic breast cancer: A commentary on a survey of Canadian Medical Oncologists

Prediction of Microscopic Metastases in Patients with Metachronous Oligo-Metastases after Curative Treatment of Non-Small Cell Lung Cancer: A Microsimulation Study

Prediction of microscopic metastases in patients with metachronous oligo-metastases after curative treatment of Non-Small Cell Lung Cancer

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