Is Radiation-before-pathology a Feasible Approach in the Palliative Oncology Setting? A Pragmatic Clinical Trial
ConditionCancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDavid Palma
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
Participants with convincing clinical/radiological evidence of cancer, ineligible for curative treatment and awaiting a biopsy.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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).
Time frame
2 weeks after biopsy resultsSecondary outcomes
1
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.
Time frame
2 weeks after biopsy results2
Molecular Testing Accuracy
Molecular testing accuracy is defined as the percentage of biopsies that yielded enough viable tissue for molecular testing/diagnosis.
Time frame
2 weeks after biopsy results3
Number of Biopsy Attempts Required
Time frame
2 weeks after biopsy4
Biopsy Complication Rates
Time frame
2 weeks after biopsySponsors and contacts
Click on the lead sponsor to view all of their trials.
David Palma
Lead sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor institution
Source ClinicalTrials.gov