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• W2972678222 abstract "Much of the progress in the definitive treatment of head and neck cancer (HNC) has come with combining radiation therapy (RT) and systemic therapy (ST). Yet RT-specific advances that draw upon radiobiologic principles (dose and fractionation) and technology (e.g. IMRT) have also led to improvements in HNC outcome. We aimed to characterize current HNC clinical trials, focusing on the role of RT to determine how often RT-specific hypotheses are tested. A web query of all open interventional trials on www.ClinicalTrials.gov was performed on 6/27/2017 using search terms “head and neck cancer” and specific HNC subsites. The details of each trial were characterized including the type of modality utilized (RT, drug, surgery, or other), principal investigator (PI) specialty, study funding, and whether the study tested a RT-modality specific hypothesis (focused on comparing RT dose, fractionation, techniques, use of any RT, or other). There were 841 open HNC trials identified including definitive (47.6%) and recurrent/metastatic (41.9%) populations. Most trials were phase I or non-randomized phase II studies (71.7%), rather than phase III or randomized phase II (28.3%). Among phase III and randomized phase II trials, most trials tested the combination of RT with ST (49.8%), while only 11.1% tested an RT-specific hypothesis such as dose, fractionation, modality (e.g. SBRT, protons, etc.), (p < 0.001). More trials tested an RT-specific hypothesis if one of the study PIs was a radiation oncologist (20.9% vs 6.0%, p < 0.001). Among RT-only trials, most early-phase studies tested novel treatment modalities (e.g. stereotactic radiation or proton therapy), while most later-phase studies tested dose and fractionation. RT-specific trials had low rates of federal (10.4%) or industry (2.6%) funding. RT modality-specific research hypotheses are a minority of phase II-III HNC trials, which mostly focus on incorporating ST in the definitive or recurrent/metastatic setting. Radiation oncologist PI leadership is likely to be an important factor in ensuring that radiobiologic, technologic, and other RT-specific hypotheses are incorporated into trial design to maximally exploit the potential for RT to improve HNC outcomes whether alone or in combination with ST." @default.
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• W2972678222 date "2019-09-01" @default.
• W2972678222 modified "2023-10-17" @default.
• W2972678222 title "Radiation Therapy in Head and Neck Cancer Clinical Research – Is there Room to Exploit Radiation-Specific Principles in Clinical Trial Design with or without Systemic Therapy?" @default.
• W2972678222 doi "https://doi.org/10.1016/j.ijrobp.2019.06.1639" @default.
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