RAPTOR: Randomised Controlled Trial of PENTOCLO (pentoxifylline-tocopherol-clodronate) in Mandibular Osteoradionecrosis-study protocol for an open-label phase II randomised controlled superiority trial.

ABSTRACT:

Background

Mandibular osteoradionecrosis (ORN) is a severe late radiation toxicity affecting 5-10% of patients who receive radiotherapy as part of treatment for head and neck malignancy. ORN can cause permanent disfigurement, dysfunction, pain and infection. There remains little robust evidence supporting the efficacy of medical or surgical management currently offered in clinical practice. Retrospective case series and meta-analyses of observational studies suggest that a repurposed triple drug combination pentoxifylline-tocopherol-clodronate ('PENTOCLO') may be effective in preventing deterioration, promoting healing and ultimately reducing the need for major reconstructive surgery.

Methods

The RAPTOR trial is a phase II, open-label, multicentre, randomised controlled tria

SUBMITTER: Shaw R 

PROVIDER: S-EPMC12291413 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature