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

NCT06156800 | Recruiting DMC

• 1 other identifier: RT-NOW
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Keywords

Palliative Irradiation; Biopsy; Radiation Therapy; Pathology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Histological Diagnostic Accuracy

  2 weeks after biopsy results

• Molecular Testing Accuracy

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• Participant is potentially eligible for curative treatment

Sponsors & Collaborators

• David Palma: lead

Study Sites (1)

London Regional Cancer Program, London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

RECRUITING

Related Publications (1)

• Young S, O'Neil M, Laba JM, Nguyen TK, Qu XM, Goodman CD, Bauman GS, Warner A, Cecchini M, Palma DA. Radiation-before-pathology approach in the palliative oncology setting: a pragmatic clinical trial protocol (RT-NOW). BMC Palliat Care. 2025 Apr 7;24(1):96. doi: 10.1186/s12904-025-01724-3.

  PMID: 40189509 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• David Palma, MD

  London Health Sciences Centre, Lawson Health Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Palma, MD

CONTACT

519-685-8650; David.Palma@lhsc.on.ca

Sympascho Young, MD

CONTACT

Sympascho.Young@lhsc.on.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: December 5, 2023
• Study Start: April 19, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)