What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Adaptive radiotherapy, or standard radiotherapy. The registry lists allocation as randomized. Trimodal therapy (TMT) consisting of transurethral resection of bladder tumors followed by radiotherapy and chemotherapy is a therapeutic alternative in patients with Muscle-Infiltrating Bladder Cancer who are inoperable or refuse surgery.
They plan to enroll about 120 people at 11 sites. Taking part typically means a procedure as part of the study plus check-ins.
Official title (unrewritten)
Randomized Open Phase II Multienter Study Evaluating the Clinical Utility of Online Adaptive Radiotherapy in Bladder Cancer
Interventions: Adaptive radiotherapy, standard radiotherapy
Primary outcome (registry wording): evaluation of the technique of adaptive radiotherapy in terms of acute Gastro-Intestinal toxicity.