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

NCT ID: NCT06156800

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 48 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-19
• Study Completion Date: 2027-07-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

David Palma

OTHER

Sponsor Role: lead

Responsible Party

David Palma

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

David Palma, MD

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre, Lawson Health Research Institute

Locations

London Regional Cancer Program, London Health Sciences Centre

London, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

David Palma, MD

Role: CONTACT

David.Palma@lhsc.on.ca

519-685-8650

Sympascho Young, MD

Role: CONTACT

Sympascho.Young@lhsc.on.ca

Facility Contacts

David Palma, MD

Role: primary

David.Palma@lhsc.on.ca

519-685-8650

References

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.

Reference Type: DERIVED

PMID: 40189509 (View on PubMed)

Other Identifiers

RT-NOW

Identifier Type: -

Identifier Source: org_study_id