Resectable Pancreatic AdenocarcinomaANSR-PDACNCT04915417
Neoadjuvant Stereotactic Ablative Radiotherapy for Pancreatic Ductal Adenocarcinoma
A study testing Stereotactic Ablative Body Radiotherapy (SABR) in people with Resectable Pancreatic Adenocarcinoma and Borderline Resectable Pancreatic Adenocarcinoma, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
Trial summary
Pancreatic cancer (PC) is expected to be the third leading cause of cancer death in Canada in 2019 [1]. Localized pancreatic cancer may be classified as resectable, borderline resectable, or locally advanced. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable Pancreatic Adenocarcinoma, Borderline Resectable Pancreatic Adenocarcinoma
- What is being tested?
- Stereotactic Ablative Body Radiotherapy (SABR)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2021to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Age 18 or older
- Able to provide informed consent
- Histologically confirmed primary pancreatic cancer, or willing to undergo endoscopic ultrasound (EUS) with synchronous fiducial marker placement and biopsy
- No evidence of distant metastases (M0)
- Medically fit to undergo surgical resection
- Life expectancy >6 months
Show all 13Show fewer
- Adequate renal function to tolerate contrast dye for imaging
- ECOG Performance Status 0-2 Inclusion Criteria (Arm 1)
- Upfront resectable pancreatic cancer
- No evidence of nodal disease (N0)
- Appropriate to undergo a pancreaticoduodenectomy within 4-6 weeks of registration
- Borderline resectable or upfront resectable pancreatic cancer
- Plan for surgical resection independent of the biochemical or radiographic response to SABR
Who cannot join
- Serious medical comorbidities or other contraindications to radiotherapy or surgery
- Gross disease involving duodenum or stomach
- Unable to have fiducials placed.
- Recurrent pancreatic cancer
- Prior abdominal radiation at any time
- Inability to attend full course of radiotherapy, surgery, or follow-up visits
Show all 10Show fewer
- Contrast allergy
- Pregnant or lactating women
- Receipt of any neoadjuvant system therapy, standard cytotoxic therapy or experimental
- Elevated bilirubin or liver enzymes considered to be a contraindication to irinotecan chemotherapy, unless an intervention is planned to improve hepatic functioning
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Pilot Study to Assess the Safety and Feasibility of Neoadjuvant Stereotactic Ablative Radiotherapy for Pancreatic Ductal Adenocarcinoma
Pancreatic cancer (PC) is expected to be the third leading cause of cancer death in Canada in 2019 [1]. Localized pancreatic cancer may be classified as resectable, borderline resectable, or locally advanced. To date, radical surgical resection and adjuvant treatment provide the greatest chance of long-term disease control and overall survival [2,3]. Despite this favourable group, the five-year survival rates are approximately 20% [4].
Neoadjuvant therapy (NAT) for resectable pancreatic cancer (RPC) has been widely accepted for the management of borderline resectable PC (BRPC) to increase the likelihood of achieving R0 resection [4-7]. However, to date, NAT for RPC is still an area of debate due to the lack of large prospective randomized controlled trials that compare this technique to surgery plus adjuvant therapy.
Read more
Stereotactic ablative radiation therapy (SABR) uses modern radiotherapy planning and targeting technologies to precisely deliver larger, ablative doses of radiotherapy in 1-8 fractions. The role of SABR in RPC has yet to be fully established. The typical goal of radiation therapy in the neoadjuvant setting is to improve local control and increase R0 resection rates. However, there are still concerns about the timing of surgery after SABR and any implementation should be evaluated for safety.
Treatments inherently changes the tumour and can cause immunomodulatory effects. SABR has anti-neoplastic effects both directly on the tumour and by its interactions with the immune system. In addition to the direct DNA damage, it is felt that SABR also increases T-cell priming, antigen production and presentation. Pancreatic cancer's dense, collagen rich stroma has prevented patients from receiving the same benefits of checkpoint inhibition that have been achieved in other cancer sites.
Read the detailed description
Goals: The primary goals of this study are to evaluate the safety and feasibility of neoadjuvant SABR patients with surgical PC. This proposal is specifically intended to strengthen the correlative sciences evaluating pre- and post-treatment tissue samples and serial plasma samples evaluating the immunomodulatory effects of neoadjuvant SABR.
Population: Patients with upfront resectable pancreatic adenocarcinoma (RPC) with a plan to proceed directly to curative surgery or borderline resectable pancreatic adenocarcinoma (BRPC) with a plan for neoadjuvant FOLFIRINOX chemotherapy with the hopes of then proceeding to a curative surgical resection will be accrued.
Objectives and Endpoints: The primary objective is to determine the safety and feasibility of neoadjuvant SABR in patients with PC. Secondary objectives include (1) determining the tumor perfusion with serial dynamic contrast enhanced CT imaging studies; (2) evaluating serial peripheral blood samples for changes in markers of inflammation or immune activation using O-link's plasma-based proteomics platform; (3) T-cell receptor (TCR) sequencing from RNA isolated from the buffy coat from serial whole blood samples; (4) Digital spatial profiling on FFPE samples from pre-treatment biopsy tissue and post-treatment surgical resection samples to examine CD3, CD8, PD-L1 expression and other markers of immunomodulation; (5) RNA sequencing (RNA-Seq) will be conducted on pre- and post-treatment samples to examine the gene expression profile within specific areas of the tumor environment; (6) examining the influence of SABR on classic biomarkers such as CEA and CA19-9.
Methodology: Upfront RPC (n=10) and BRPC (n=20) with the expectation of approximately 10 participants receiving neoadjuvant SABR on study.
Imaging Studies: Patients in both arms will receive both a hybrid PET/MRI scan and a dynamic contrast enhanced (DCE-CT) scan prior to SABR to define high metabolic regions (using 18F-FDG PET), define the whole tumour border (using MRI), and to define baseline perfusion parameters such as blood flow, blood volume, permeability surface, and mean transit time (using DCE-CT). This information will be used to define regions that will receive high doses of radiation therapy. These patients will also receive a DCE-CT scan six hours after the first of three radiation treatments and 4 weeks following SABR (before surgery) to investigate changes in blood flow.
- Being tested
- Stereotactic Ablative Body Radiotherapy (SABR)
- Keywords
- Stereotactic Ablative Body Radiation Therapy, Neoadjuvant, Pancreatic Adenocarcinoma, Hybrid PET/MRI, CT Perfusion, Blood Proteomics, Immunomodulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Ablative Body Radiotherapy (SABR)Radiation
Patients will receive 27-30 Gy in 3 fractions to the planning target volume (PTV) with a simultaneous in-field boost to the metabolically active areas of the gross tumor volume (GTV) to a maximum of 45 Gy. Patients will be treated every other day.
| Study group | Role | What they receive |
|---|---|---|
| Resectable Pancreatic Ductal Adenocarcinoma (PDAC) | Experimental | 10 Resectable PDAC patients will receive a hybrid PET/MRI before SABR and DCE-CT before SABR, 6 hours after the first SABR fraction, and 4 weeks after the last fraction of SABR (before surgery) Receives: Radiation: Stereotactic Ablative Body Radiotherapy (SABR) |
| Borderline Resectable Pancreatic Ductal Adenocarcinoma (PDAC) | Experimental | 20 Borderline Resectable PDAC patients will receive a DCE-CT scan prior to neoadjuvant chemotherapy, a PET/MRI and DCE-CT after neoadjuvant chemotherapy and before SABR, DCE-CT at 6 hours after the first SABR fraction, and 4 weeks after the last fraction of SABR (before surgery) Receives: Radiation: Stereotactic Ablative Body Radiotherapy (SABR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity of Neoadjuvant SABR
Patients will be evaluated for toxicity during their follow-up exams according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Measured: 2 years
Quality of Life (QOL)
QOL will be measured using the Functional Assessment of Cancer Therapy for Hepatobiliary and Pancreatic Subscale (FACT-Hep HCS)
Measured: 2 years
Secondary outcomes (16)
Change in tumor blood flow assessed by dynamic contrast enhanced CT imaging
Dynamic Contrast enhanced CT imaging will be used to calculate tumor blood flow (ml^-1) within 2 weeks after completion of chemotherapy and calculate the change compared to baseline
Measured: <2 weeks after completion of chemotherapy (Arm 2 only)
Change in tumor blood flow assessed by dynamic contrast enhanced CT imaging
Dynamic Contrast enhanced CT imaging will be used to calculate tumor blood flow (ml^-1) within 6 hours after first fraction of radiation therapy and calculate the change compared to baseline
Measured: <6 hours after first fraction of radiation therapy (Arm 1 only)
Change in tumor blood flow assessed by dynamic contrast enhanced CT imaging
Dynamic Contrast enhanced CT imaging will be used to calculate tumor blood flow (ml^-1) within 6 hours after first fraction of radiation therapy and calculate the change compared to that post-chemotherapy
Measured: <6 hours after first fraction of radiation therapy (Arm 2 only)
Change in tumor blood flow assessed by dynamic contrast enhanced CT imaging
Dynamic Contrast enhanced CT imaging will be used to calculate tumor blood flow (ml^-1) within 2-4 weeks after completion of radiation therapy and calculate the change compared to baseline
Measured: 2-4 weeks after radiation completed (Arm 1 only)
Change in tumor blood flow assessed by dynamic contrast enhanced CT imaging
Dynamic Contrast enhanced CT imaging will be used to calculate tumor blood flow (ml^-1) 2-4 weeks after completion of radiation therapy and calculate the change compared to that post-chemotherapy
Measured: 2-4 weeks after radiation completed (Arm 2 only)
Predictive Value of Imaging Biomarkers of tumor metabolic uptake
Predictive value of 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG)-PET imaging biomarkers compared to pathologic outcome (complete response or non-complete response to treatment
Measured: 2 years
Tumor recurrence
Time to local recurrence, regional recurrence, and distant recurrence of disease will be measured
Measured: 2 years
Change in Cancer Antigen (CA) 19-9 expression
Change in CA19-9 detected in blood samples acquired before and after radiation therapy
Measured: 2 years
Change in Carcinoembryonic antigen (CEA) expression
Change in CEA detected in blood samples acquired before and after radiation therapy
Measured: 2 years
Detection of CD8+ T-cells
Peripheral blood samples will be evaluated using a plasma-based proteomics platform to detect T-cells after radiation therapy to examine peripheral markers of tumor immunity
Measured: 2 years
Changes in markers of immune expression (CD3)
FFPE samples from pre-treatment biopsy tissue and post-treatment surgical resection samples to examine CD3 expression
Measured: 2 years
Changes in markers of immune expression (CD8)
FFPE samples from pre-treatment biopsy tissue and post-treatment surgical resection samples to examine CD8 expression
Measured: 2 years
Changes in markers of immune expression (PD-L1)
FFPE samples from pre-treatment biopsy tissue and post-treatment surgical resection samples to examine PD-L1 expression
Measured: 2 years
Downstaging Rate (Arm 2)
Arm 2 patients will be re-evaluated for surgical resection. The ratio of the number of patients who proceed to surgery to the total number of patients that receive neoadjuvant FOLFIRINOX + SABR will be determined and subsequent therapy will be decided.
Measured: 2-4 weeks post SABR
Negative Margin Resection Rate
Arm 1 patients (rPC) will be evaluated to ensure they remain fit for surgery. R0 vs. R1 resection will be determined and subsequent therapy will be decided. R0 vs. R1 resection will also be determined for Arm 2 (BRCP) patients that receive resection and subsequent therapy will be decided.
Measured: Immediately post surgery
True Pathological Complete Response (PCR)
For both arms, those who exhibit a lack of viable tumor after surgical resection (e.g. a pathologic complete response [pCR]), which will be reported as the patients with a complete response, divided by the total number of patients undergoing resection, with a 95% confidence interval (CI).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start1 Aug 2021 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- London Health Sciences Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915417
- Sponsor's protocol ID
- 118543
- Acronym
- ANSR-PDAC
- Status last verified
- May 2021
- First submitted
- 14 May 2021
- Last updated
- 22 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Safety and Feasibility of Neoadjuvant Stereotactic Ablative Radiotherapy for Pancreatic Ductal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT04915417
- Acronym / sponsor ID
- ANSR-PDAC / 118543
- Keywords
- Stereotactic Ablative Body Radiation Therapy, Neoadjuvant, Pancreatic Adenocarcinoma, Hybrid PET/MRI, CT Perfusion, Blood Proteomics, Immunomodulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- London Health Sciences Foundation
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 7 Jun 2021 (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.
Pancreatic cancer (PC) is expected to be the third leading cause of cancer death in Canada in 2019 [1]. Localized pancreatic cancer may be classified as resectable, borderline resectable, or locally advanced. To date, radical surgical resection and adjuvant treatment provide the greatest chance of long-term disease control and overall survival [2,3]. Despite this favourable group, the five-year survival rates are approximately 20% [4].
Neoadjuvant therapy (NAT) for resectable pancreatic cancer (RPC) has been widely accepted for the management of borderline resectable PC (BRPC) to increase the likelihood of achieving R0 resection [4-7]. However, to date, NAT for RPC is still an area of debate due to the lack of large prospective randomized controlled trials that compare this technique to surgery plus adjuvant therapy.
Stereotactic ablative radiation therapy (SABR) uses modern radiotherapy planning and targeting technologies to precisely deliver larger, ablative doses of radiotherapy in 1-8 fractions. The role of SABR in RPC has yet to be fully established. The typical goal of radiation therapy in the neoadjuvant setting is to improve local control and increase R0 resection rates. However, there are still concerns about the timing of surgery after SABR and any implementation should be evaluated for safety.
Treatments inherently changes the tumour and can cause immunomodulatory effects. SABR has anti-neoplastic effects both directly on the tumour and by its interactions with the immune system. In addition to the direct DNA damage, it is felt that SABR also increases T-cell priming, antigen production and presentation. Pancreatic cancer's dense, collagen rich stroma has prevented patients from receiving the same benefits of checkpoint inhibition that have been achieved in other cancer sites.
Detailed description
Goals: The primary goals of this study are to evaluate the safety and feasibility of neoadjuvant SABR patients with surgical PC. This proposal is specifically intended to strengthen the correlative sciences evaluating pre- and post-treatment tissue samples and serial plasma samples evaluating the immunomodulatory effects of neoadjuvant SABR.
Population: Patients with upfront resectable pancreatic adenocarcinoma (RPC) with a plan to proceed directly to curative surgery or borderline resectable pancreatic adenocarcinoma (BRPC) with a plan for neoadjuvant FOLFIRINOX chemotherapy with the hopes of then proceeding to a curative surgical resection will be accrued.
Objectives and Endpoints: The primary objective is to determine the safety and feasibility of neoadjuvant SABR in patients with PC. Secondary objectives include (1) determining the tumor perfusion with serial dynamic contrast enhanced CT imaging studies; (2) evaluating serial peripheral blood samples for changes in markers of inflammation or immune activation using O-link's plasma-based proteomics platform; (3) T-cell receptor (TCR) sequencing from RNA isolated from the buffy coat from serial whole blood samples; (4) Digital spatial profiling on FFPE samples from pre-treatment biopsy tissue and post-treatment surgical resection samples to examine CD3, CD8, PD-L1 expression and other markers of immunomodulation; (5) RNA sequencing (RNA-Seq) will be conducted on pre- and post-treatment samples to examine the gene expression profile within specific areas of the tumor environment; (6) examining the influence of SABR on classic biomarkers such as CEA and CA19-9.
Methodology: Upfront RPC (n=10) and BRPC (n=20) with the expectation of approximately 10 participants receiving neoadjuvant SABR on study.
Imaging Studies: Patients in both arms will receive both a hybrid PET/MRI scan and a dynamic contrast enhanced (DCE-CT) scan prior to SABR to define high metabolic regions (using 18F-FDG PET), define the whole tumour border (using MRI), and to define baseline perfusion parameters such as blood flow, blood volume, permeability surface, and mean transit time (using DCE-CT). This information will be used to define regions that will receive high doses of radiation therapy. These patients will also receive a DCE-CT scan six hours after the first of three radiation treatments and 4 weeks following SABR (before surgery) to investigate changes in blood flow.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resectable Pancreatic Ductal Adenocarcinoma (PDAC) | Experimental | Radiation: Stereotactic Ablative Body Radiotherapy (SABR)10 Resectable PDAC patients will receive a hybrid PET/MRI before SABR and DCE-CT before SABR, 6 hours after the first SABR fraction, and 4 weeks after the last fraction of SABR (before surgery) |
| Borderline Resectable Pancreatic Ductal Adenocarcinoma (PDAC) | Experimental | Radiation: Stereotactic Ablative Body Radiotherapy (SABR)20 Borderline Resectable PDAC patients will receive a DCE-CT scan prior to neoadjuvant chemotherapy, a PET/MRI and DCE-CT after neoadjuvant chemotherapy and before SABR, DCE-CT at 6 hours after the first SABR fraction, and 4 weeks after the last fraction of SABR (before surgery) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age 18 or older
- Able to provide informed consent
- Histologically confirmed primary pancreatic cancer, or willing to undergo endoscopic ultrasound (EUS) with synchronous fiducial marker placement and biopsy
- No evidence of distant metastases (M0)
- Medically fit to undergo surgical resection
Key exclusion criteria (10 listed)
- Serious medical comorbidities or other contraindications to radiotherapy or surgery
- Gross disease involving duodenum or stomach
- Unable to have fiducials placed.
- Recurrent pancreatic cancer
- Prior abdominal radiation at any time
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Ablative Body Radiotherapy (SABR)Patients will receive 27-30 Gy in 3 fractions to the planning target volume (PTV) with a simultaneous in-field boost to the metabolically active areas of the gross tumor volume (GTV) to a maximum of 45 Gy. Patients will be treated every other day. | Radiation | Borderline Resectable Pancreatic Ductal Adenocarcinoma (PDAC), Resectable Pancreatic Ductal Adenocarcinoma (PDAC) |
Primary outcome
Toxicity of Neoadjuvant SABR
Time frame: 2 years
Patients will be evaluated for toxicity during their follow-up exams according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Quality of Life (QOL)
Time frame: 2 years
QOL will be measured using the Functional Assessment of Cancer Therapy for Hepatobiliary and Pancreatic Subscale (FACT-Hep HCS)
16 secondary outcomes
Change in tumor blood flow assessed by dynamic contrast enhanced CT imaging
Time frame: <2 weeks after completion of chemotherapy (Arm 2 only)
Change in tumor blood flow assessed by dynamic contrast enhanced CT imaging
Time frame: <6 hours after first fraction of radiation therapy (Arm 1 only)
Change in tumor blood flow assessed by dynamic contrast enhanced CT imaging
Time frame: <6 hours after first fraction of radiation therapy (Arm 2 only)
Change in tumor blood flow assessed by dynamic contrast enhanced CT imaging
Time frame: 2-4 weeks after radiation completed (Arm 1 only)
Change in tumor blood flow assessed by dynamic contrast enhanced CT imaging
Time frame: 2-4 weeks after radiation completed (Arm 2 only)
Predictive Value of Imaging Biomarkers of tumor metabolic uptake
Time frame: 2 years
Tumor recurrence
Time frame: 2 years
Change in Cancer Antigen (CA) 19-9 expression
Time frame: 2 years
Change in Carcinoembryonic antigen (CEA) expression
Time frame: 2 years
Detection of CD8+ T-cells
Time frame: 2 years
Changes in markers of immune expression (CD3)
Time frame: 2 years
Changes in markers of immune expression (CD8)
Time frame: 2 years
Changes in markers of immune expression (PD-L1)
Time frame: 2 years
Downstaging Rate (Arm 2)
Time frame: 2-4 weeks post SABR
Negative Margin Resection Rate
Time frame: Immediately post surgery
True Pathological Complete Response (PCR)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Ablative Body Radiotherapy (SABR) in people with Resectable Pancreatic Adenocarcinoma and Borderline Resectable Pancreatic Adenocarcinoma, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
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 13 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stewart Gaede (5196858605, stewart.gaede@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity of Neoadjuvant SABR (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2021.