CancerRT-NOWNCT06156800
Is Radiation-before-pathology a Feasible Approach in the Palliative Oncology Setting? A Pragmatic Clinical Trial
An observational study of Cancer, run by David Palma at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- 19 Apr 2024to 1 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with convincing clinical/radiological evidence of cancer, ineligible for curative treatment and awaiting a biopsy.
Who may be able to join
- 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.
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- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sympascho Young, MD contact
Canada1 site, 1 recruiting
- Recruiting
London Regional Cancer Program, London Health Sciences Centre
London, Ontario, N6A 5W9
David Palma, MD, 519-685-8650, David.Palma@lhsc.on.ca
About this study
Official title: Is Radiation-before-pathology a Feasible Approach in the Palliative Oncology Setting? A Pragmatic Clinical Trial (RT-NOW)
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
- Keywords
- Palliative Irradiation, Biopsy, Radiation Therapy, Pathology
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 weeks after biopsy results
Secondary outcomes (9)
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.
Measured: 2 weeks after biopsy results
Molecular Testing Accuracy
Molecular testing accuracy is defined as the percentage of biopsies that yielded enough viable tissue for molecular testing/diagnosis.
Measured: 2 weeks after biopsy results
Number of Biopsy Attempts Required
Measured: 2 weeks after biopsy
Biopsy Complication Rates
Measured: 2 weeks after biopsy
Time from Enrollment to First Fraction of Radiation Therapy
Measured: Within 1 year after enrollment
Time from Enrollment to Biopsy
Measured: Within 1 year after enrollment
Evidence of Radiation Effect in Biopsy
Measured: 2 weeks after biopsy results
Overall Survival
Measured: 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.
Measured: 2 weeks after radiation therapy of 2 weeks after biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start19 Apr 2024
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Palma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Palma, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- David Palma, MD, Principal investigator, London Health Sciences Centre, Lawson Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156800
- Sponsor's protocol ID
- RT-NOW
- Acronym
- RT-NOW
- Status last verified
- Sep 2026
- First submitted
- 7 Nov 2023
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40189509
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Radiation-before-pathology a Feasible Approach in the Palliative Oncology Setting? A Pragmatic Clinical Trial (RT-NOW)
- ClinicalTrials.gov ID
- NCT06156800
- Acronym / sponsor ID
- RT-NOW / RT-NOW
- Conditions
- Cancer
- Keywords
- Palliative Irradiation, Biopsy, Radiation Therapy, Pathology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- David PalmaUniversity, hospital or other
- Study start
- 19 Apr 2024 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 5 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with convincing clinical/radiological evidence of cancer, ineligible for curative treatment and awaiting a biopsy.
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percent of Inappropriate Use of Radiation Therapy in Participants with Urgent Indications Treated Prior to Biopsy Results
Time frame: 2 weeks after 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).
9 secondary outcomes
Histological Diagnostic Accuracy
Time frame: 2 weeks after biopsy results
Molecular Testing Accuracy
Time frame: 2 weeks after biopsy results
Number of Biopsy Attempts Required
Time frame: 2 weeks after biopsy
Biopsy Complication Rates
Time frame: 2 weeks after biopsy
Time from Enrollment to First Fraction of Radiation Therapy
Time frame: Within 1 year after enrollment
Time from Enrollment to Biopsy
Time frame: Within 1 year after enrollment
Evidence of Radiation Effect in Biopsy
Time frame: 2 weeks after biopsy results
Overall Survival
Time frame: 1 year after enrollment
Edmonton Symptom Assessment System Revised Scores
Time frame: 2 weeks after radiation therapy of 2 weeks after biopsy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Derived from this study: PubMed 40189509Young 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sympascho Young, MD contact
David Palma, MD principal investigator
London Health Sciences Centre, Lawson Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by David Palma at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Palma, MD (519-685-8650, David.Palma@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Inappropriate Use of Radiation Therapy in Participants with Urgent Indications Treated Prior to Biopsy Results (time frame: 2 weeks after biopsy results). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06156800, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.