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• W2973201797 abstract "Phase II (PII) trials test efficacy and side effects of interventions in advance of costly Phase III (PIII) trials. Traditionally deployed as single arm studies, the use of randomized PII (RPII) trials has increased in an effort to reduce bias while achieving adequate power with modest sample size. In radiation oncology, randomized trials fail at a high rate, with poor accrual the most frequent cause. Innovative trial designs, including novel PII ‘screening’ designs which compare experimental and standard interventions with less stringent type I/II error, may improve success rates. We sought to review and characterize the use of RPII trials in Radiation Oncology over the past 12 years. To identify radiotherapy (RT) RPII trials, clinicaltrials.gov was queried between 2007 and 2018. Inclusion criteria included interventional RPII designs involving RT for cancer that had completed, finished accrual, or been stopped. Included trials had variations in radiation technique (use, dose, fractionation, target, etc.) between arms. Trials with identical RT prescriptions between arms were excluded. Two independent reviewers screened titles and trial records. Multiple factors were abstracted including design (selection, screening, phase II/III, parallel non-comparative [PNC]), type of investigation (RT vs no RT, RT technique), endpoints, etc. For completed trials with results, clinicaltrials.gov and PubMed were queried to identify associated studies. Publications resulting from screened trials were reviewed and abstracted. Of 504 search results, 112 met inclusion criteria. Screening-type trials were most common (67), followed by selection (34), phase II/III (10) and PNC (1). From 2007-2018 inclusive, 26 studies published abstracts or manuscripts including 12 (18%) screening, 9 selection (26%), 4 phase II/III (40%) and 1 PNC (100%). Of published trials 16 were considered positive, 5 equivocal, 3 negative, and 2 indeterminate due to low accrual; 14 recommended PIII, and 6 referenced ongoing PIII trials on the topic. Three PIII trials directly linked to successful RPII were identified. Accrual was the most common cause of failure (16). Most common sites included lung (25), prostate (16), and head & neck (12), with a mix between early (32), locally advanced (46) and metastatic (34) stage. Oligometastatic disease was investigated in 12 trials, with 5 trials investigating stereotactic RT with immunotherapy. Most studies examined variations in RT technique (64) while the remainder compared RT with an alternate treatment. Most common endpoints included toxicity (24), progression free survival (20), and response rate (16). Over the past 12 years there have been several successfully completed, positive RPII trials, but most have not clearly led to randomized PIII trials. Further investigation is warranted on the relationship between RPII trial design and success, the link between successful RPII trials and PIII trials." @default.
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• W2973201797 date "2019-09-01" @default.
• W2973201797 modified "2023-10-18" @default.
• W2973201797 title "Don't Be Fazed by Phase II: The Use of Randomized Phase II Trials in Radiation Oncology" @default.
• W2973201797 doi "https://doi.org/10.1016/j.ijrobp.2019.06.1145" @default.
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