Radiation-before-pathology approach in the palliative oncology setting: a pragmatic clinical trial protocol (RT-NOW).

Background: Patients with incurable but not-yet-biopsied cancers sometimes require urgent palliative radiation. However, wait-times for biopsy procedures and pathologic results can delay treatment, with significant consequences to patient quality of life and/or the chance of irreversible cancer complications. There is no prospective data to guide empirical decision-making in these urgent, palliative contexts.

Methods: In this prospective single-arm pragmatic clinical trial, we will enrol 48 patients with incurable cancer where a biopsy is delaying urgent palliative radiation. Patients will receive empiric upfront palliative radiation without biopsy-confirmation. The primary endpoint is the rate of inappropriate radiation, defined when the patient's biopsy shows a non-malignant entity or a malignancy that is better treated upfront with systemic therapy (or therapy other than radiation). Secondary endpoints include: histologic diagnostic accuracy, molecular testing accuracy, biopsy complications rates, evidence of radiation effect in biopsy, time from enrolment to radiation/biopsy, and Edmonton Symptom Assessment Scale (ESAS) scores. Patients are eligible only if the probability of incurable malignancy is deemed > 95% and the risk of lymphoma < 20% by the treating physician, based on clinical examination and imaging investigations.

Discussion: This study will provide prospective data to guide oncologists and patients in making informed decisions when weighing the competing risks of delaying palliative radiation versus treating without pathologic confirmation.

Trial registration: ClinicalTrials.gov Identifier: NCT06156800. Date of registration: December 5, 2023.