assessed, characteristics of cCRT phase II trials have never been reported. The objective was to describe features of all cCRT phase II trials. Materials/Methods: Requests were performed in the Medline database (via PubMed) using MESH terms: "clinical trials: phase II as topic", "chemoradiotherapy". Results: 458 cCRT phase II trials were identified, mainly with multicenter (51.5%), single arm studies (77.7%) published after 2011 (55.0%). The median number of included patients was 52. Primary endpoints were mainly response rate (20.5%) and pathological complete response (14.4%). The primary endpoint was not defined in 22% of studies. Tumors were mostly lung (23.1%) and head and neck (20.3%) cancers treated at a locally advanced setting (81.7%). 55.2% of trials used 3D-conformal radiotherapy and 9.1% intensity-modulated radiotherapy, mainly with normo-fractionation (82.0% of the 573 arms with radiotherapy). Radiation technique was not reported in 19.9% of studies. Associated anticancer drugs (563 arms) were mainly conventional chemotherapies (559 arms): cisplatin (46.2%) and 5-fluorouracil (28.3%). Non cytotoxic agents (targeted therapies, immunotherapies) were tested in 97 arms (17%). With a median follow-up of 31 months, acute grade 3e5 were reported in 98.5% of studies and late toxicities in 44.5%. Follow-up was not reported in 17% of studies. Conclusion: cCRT Phase II trials featured severe limitations, with outdated radiation techniques, insufficient reporting of crucial data and a small number of included patients. This certainly hindered the development of successful phase III trials.
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