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

## TL;DR

This clinical trial explores giving urgent radiation to patients with suspected incurable cancer before a biopsy to improve treatment timing and quality of life.

## Contribution

The study introduces a pragmatic trial protocol for empiric radiation before biopsy in palliative oncology, addressing a gap in clinical decision-making.

## Key findings

- The trial will measure the rate of inappropriate radiation when given before biopsy confirmation.
- It will assess symptom improvement and biopsy-related complications in patients receiving early radiation.
- The study will evaluate diagnostic accuracy and treatment appropriateness based on later biopsy results.

## Abstract

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.

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.

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.

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