Is Radiation-before-pathology a Feasible Approach in the Palliative Oncology Setting? A Pragmatic Clinical Trial (RT-NOW)

Is Radiation-before-pathology a Feasible Approach in the Palliative Oncology Setting? A Pragmatic Clinical Trial (RT-NOW)

When a doctor suspects cancer, often a biopsy is taken for testing to confirm if cancer is present. Usually, doctors would wait for the results of a biopsy before delivering radiation, but this may lead to a patient having to wait for a treatment that he or she urgently needs.

With long wait times for biopsies in Canada, this may lead to symptoms and risks of complications from cancer in the meantime. Therefore, this study is being done to answer the following question: Is it safe and feasible to deliver radiation before obtaining a biopsy in a carefully selected group of patients who urgently need radiation treatment.

Study Overview

• Status: Recruiting
• Conditions: Cancer

• Study Type: Observational
• Enrollment (Estimated): 48

Contacts and Locations

• Study Contact: Name: David Palma, MD; Phone Number: 519-685-8650; Email: David.Palma@lhsc.on.ca
• Study Contact Backup: Name: Sympascho Young, MD; Email: Sympascho.Young@lhsc.on.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • Recruiting
      • London Regional Cancer Program, London Health Sciences Centre
      • Contact: David Palma, MD; Phone Number: 519-685-8650; Email: David.Palma@lhsc.on.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants with convincing clinical/radiological evidence of cancer, ineligible for curative treatment and awaiting a biopsy.

Description

Inclusion Criteria:

• Age 18 years or older
• Willing to provide informed consent
• Palliative treatment intent: either metastatic or incurable locally advanced disease
• Tissue diagnosis is not required for determination of dose/fractionation scheme
• Recent cross-sectional imaging [for example - Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Positron Emission Tomography/Computed Tomography (PET/CT)] of the area to be treated, done within the past 3 months
• Treating physician considers the pre-test probability of cancer greater than 95 percent based on clinical judgement and radiological findings.

• The patient has at least 1 site of cancer amenable to biopsy

  • As per standard practices, if the radiation oncologist will be radiating the only site available to biopsy, they should proceed with caution. Participants should only be enrolled on trial if the risk of harm from delaying Radiation Therapy (RT) significantly outweighs the risks of possible non-diagnostic tissue. If the participant may potentially be eligible for systemic therapy, the treating radiation oncologist should consult a medical oncologist for an opinion regarding the risks of non-diagnostic molecular testing. The weighing of these priorities should be thoroughly discussed with the participant and the discussion should be documented.

  • Reasons for radiating a participant with a single lesion prior to biopsy include:

    • Spinal cord compression (actual or impending) and inoperable
    • Brain metastasis with significant symptoms or neurologic deficits and inoperable
    • Other lesions causing neurologic deficit
    • Pulmonary lesion causing or threatening lung obstruction
    • Uncontrolled bleeding (including hemoptysis and hematuria)
    • Superior vena cava obstruction (actual or impending)
    • Limited upside to molecular testing, as determined by the medical oncologist (for example - participant unfit for available systemic therapies, limited options for systemic therapy)

• Radiation is considered urgent (for example - participant should receive radiation prior to biopsy date) o Urgent indications may include but are not limited to the reasons listed previously, as well as the following:

  • Painful metastases or primary lesion not adequately responding to analgesia
  • Symptomatic brain metastases
  • Bleeding
  • Impending pathologic fracture

Exclusion Criteria:

• Participant is potentially eligible for curative treatment
• Clinical suspicion of lymphoma o Some features may be suggestive of lymphoma, including fever or night sweats (for example - B symptoms excluding weight loss), or imaging showing well-defined, homogenous lymphadenopathy. These findings are not exclusion criteria specifically, but should be considered by the clinician in formulating their differential diagnosis.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Inappropriate Use of Radiation Therapy in Participants with Urgent Indications Treated Prior to Biopsy Results	The percentage of participants in whom management would have differed, based on the final pathology, if the pathology had been known prior to radiation therapy. Inappropriate use of radiation therapy is defined as: If a non-cancerous process was treated, Or, the use of radiation therapy was inappropriate in hindsight (for example, the participant would have clearly been better treated with alternative options).	2 weeks after biopsy results

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histological Diagnostic Accuracy	Histological diagnostic accuracy is defined as the percentage of biopsies that yielded a histological diagnosis. This will include a comparison of diagnostic yield between biopsies done at radiated vs. non-radiated sites.	2 weeks after biopsy results
Molecular Testing Accuracy	Molecular testing accuracy is defined as the percentage of biopsies that yielded enough viable tissue for molecular testing/diagnosis.	2 weeks after biopsy results
Number of Biopsy Attempts Required		2 weeks after biopsy
Biopsy Complication Rates		2 weeks after biopsy
Time from Enrollment to First Fraction of Radiation Therapy		Within 1 year after enrollment
Time from Enrollment to Biopsy		Within 1 year after enrollment
Evidence of Radiation Effect in Biopsy		2 weeks after biopsy results
Overall Survival		1 year after enrollment
Edmonton Symptom Assessment System Revised Scores	Participants will rate their symptoms on a scale of 1 to 10, 0 being the best and 10 being the worst. Examples of symptoms included in the Edmonton Symptom Assessment System revised are pain, tiredness, nausea, appetite, depression, and so on.	2 weeks after radiation therapy of 2 weeks after biopsy

Collaborators and Investigators

• Sponsor: David Palma
• Investigators: Principal Investigator: David Palma, MD, London Health Sciences Centre, Lawson Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: November 7, 2023
• First Submitted That Met QC Criteria: December 4, 2023
• First Posted (Actual): December 5, 2023

Study Record Updates

• Last Update Posted (Actual): July 25, 2025
• Last Update Submitted That Met QC Criteria: July 22, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Biopsy; Radiation Therapy; Pathology; Palliative Irradiation
• Other Study ID Numbers: RT-NOW

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No