NCT06156800 Is Radiation-before-pathology a Feasible Approach in the Palliative Oncology Setting? A Pragmatic Clinical Trial
| NCT ID | NCT06156800 |
| Status | Recruiting |
| Phase | — |
| Sponsor | David Palma |
| Condition | Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 48 participants |
| Start Date | 2024-04-19 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 48 participants in total. It began in 2024-04-19 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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 * 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.
Contact & Investigator
David Palma, MD
PRINCIPAL INVESTIGATOR
London Health Sciences Centre, Lawson Health Research Institute
Frequently Asked Questions
Who can join the NCT06156800 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06156800 currently recruiting?
Yes, NCT06156800 is actively recruiting participants. Contact the research team at David.Palma@lhsc.on.ca for enrollment information.
Where is the NCT06156800 trial being conducted?
This trial is being conducted at London, Canada.
Who is sponsoring the NCT06156800 clinical trial?
NCT06156800 is sponsored by David Palma. The principal investigator is David Palma, MD at London Health Sciences Centre, Lawson Health Research Institute. The trial plans to enroll 48 participants.
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