Exploring early radiation treatment for cancer patients before biopsy results
Is Radiation-before-pathology a Feasible Approach in the Palliative Oncology Setting? A Pragmatic Clinical Trial (RT-NOW)
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · NCT06156800
This study is testing if giving radiation treatment to cancer patients before their biopsy results can be done safely and help reduce wait times for urgent care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT06156800 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility and safety of administering radiation therapy to cancer patients before obtaining biopsy results. It targets individuals with a high probability of cancer who require urgent treatment, aiming to reduce wait times that could lead to complications. By selecting patients based on clinical judgment and imaging findings, the study seeks to determine if early radiation can be safely implemented without compromising diagnostic outcomes. The approach is particularly relevant in settings with long biopsy wait times, such as Canada.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a high likelihood of cancer who require palliative radiation treatment.
Not a fit: Patients who do not have a high probability of cancer or those whose only biopsy site is also the site requiring radiation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce treatment delays for cancer patients, improving their quality of life and potentially their outcomes.
How similar studies have performed: While this approach is innovative, similar studies exploring early intervention in palliative care settings have shown promise, but this specific methodology is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
London, Ontario
- London Regional Cancer Program, London Health Sciences Centre — London, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: David Palma, MD — London Health Sciences Centre, Lawson Health Research Institute
- Study coordinator: David Palma, MD
- Email: David.Palma@lhsc.on.ca
- Phone: 519-685-8650
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cancer, Palliative Irradiation, Biopsy, Radiation Therapy, Pathology