Response Assessment with 18F-FDG PET/CT Scan in Patients with Anal Cancer Treated with Radical Radiotherapy

Abstract

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 Conclusion: cCRT Phase II trials featured severe limitations, with outdated radiation techniques, insufficient reporting of crucial data and a small number of included patients.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.