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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.
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| 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 |
| 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 |
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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:
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:
Exclusion Criteria:
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Participants with convincing clinical/radiological evidence of cancer, ineligible for curative treatment and awaiting a biopsy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Palma, MD | Contact | 519-685-8650 | David.Palma@lhsc.on.ca | |
| Sympascho Young, MD | Contact | Sympascho.Young@lhsc.on.ca |
| Name | Affiliation | Role |
|---|---|---|
| David Palma, MD | London Health Sciences Centre, Lawson Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Regional Cancer Program, London Health Sciences Centre | Recruiting | London | Ontario | N6A 5W9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40189509 | Derived | 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. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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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 |