Back to resultsA Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for Patients With Up to 10 Oligometastases and a Synchronous Primary Tumor. (SABR-SYNC)
Primary Purpose
Metastatic Tumor
Status
Recruiting
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Palliative Radiotherapy
Chemotherapy
Hormone therapy
Immunotherapy
Targeted Systemic Therapy
Observation
Stereotactic Ablative Radiotherapy
Surgery
Radiofrequency Therapy (RFA)
Fractionated Radiation
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Tumor
Eligibility Criteria
Inclusion Criteria: Age 18 years or older Willing to provide informed consent Karnofsky performance status > 60 Life expectancy > 6 months Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required. Total number of metastases 1-10 at the time of enrollment, with a primary tumor also present Restaging completed within 12 weeks prior to randomization (see section 5.1) For patients receiving thoracic radiotherapy, the enrolling physician must confirm there are no computed tomography (CT) changes suggestive of fibrotic interstitial lung disease (ILD) (i.e. reticular changes, traction bronchiectasis, or honeycombing) reported on any prior CT scans. If any are present, the patient must be assessed by a respirologist to rule out ILD prior to enrollment. Exclusion Criteria: Serious medical comorbidities precluding radiotherapy. These include ILD in patients requiring thoracic radiation, Crohn's disease in patients where the gastrointestinal (GI) tract will receive radiotherapy, or ulcerative colitis where the bowel will receive radiotherapy and connective tissue disorders such as lupus or scleroderma. For patients with liver metastases, moderate/severe liver dysfunction (Child Pugh B or C); please see the Child-Pugh score calculator. Substantial overlap with a previously treated radiation volume. Prior radiotherapy in general is allowed, as long as the composite plan meets dose constraints herein. For patients treated with radiation previously, biological effective dose calculations should be used to equate previous doses to the tolerance doses listed in Appendix 1. All such cases must be discussed with a member of the study steering committee. Malignant pleural effusion Inability to treat all sites of disease Brain metastasis > 3 cm in size or a total volume of brain metastases greater than 30 cc. Metastasis in the brainstem Clinical or radiologic evidence of spinal cord compression Metastatic disease that invades any of the following: GI tract (including esophagus, stomach, small or large bowel), or skin Pregnant or lactating women
Sites / Locations
- BC Cancer - Centre for the North
- London Regional Cancer Program of the Lawson Health Research InstituteRecruiting
- Centre Hospitalier de l'Université de Montréal-CHUM
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard Arm (Arm 1)
Experimental Arm (Arm 2)
Arm Description
Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications.
Consists of treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable (e.g. surgery, RFA, fractionated radiation, chemoradiation) if those are deemed to be preferable by the treating oncologists.
Outcomes
Primary Outcome Measures
Overall Survival
Time from randomization to death from any cause, or date of last follow-up, whichever occurs first.
Secondary Outcome Measures
Quality of Life (QOL) assessed with the Functional Assessment of Cancer Therapy: General (FACT-G).
Quality of Life (QOL) assessed with the Functional Assessment of Cancer Therapy: The EuroQol 5-Dimension 5-Level (EQ-5D-5L).
Toxicity assessed by the Common Toxicity Criteria for Adverse Events (CTCAE) version 5 for each organ treated (e.g. liver, lung, bone).
Time to next systemic therapy
The time from randomization until commencement of any systemic anti-cancer therapy, or date of last follow-up, whichever occurs first.
Receipt of additional radiation during follow-up
Will be collected for SABR (as a binary endpoint; yes/no), and non-SABR (yes/no).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05717166
Brief Title
A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for Patients With Up to 10 Oligometastases and a Synchronous Primary Tumor.
Acronym
SABR-SYNC
Official Title
A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for Patients With Up to 10 Oligometastases and a Synchronous Primary Tumor.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2023 (Actual)
Primary Completion Date
April 2029 (Anticipated)
Study Completion Date
April 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Palma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is a phase III multi-institutional randomized trial. Patients will be randomized in a 1:2 ratio between current standard of care treatment (Arm 1) vs. standard of care treatment + SABR (Arm 2) to sites of known disease.
Patients will be stratified by two of the strongest prognostic factors, based on a large multi-institutional analysis3: histology (Group 1: hormone-sensitive prostate cancer, breast, or renal; Group 2: all others), and number of metastases (Group 1: 1-3; Group 2: 4-10).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard Arm (Arm 1)
Arm Type
Active Comparator
Arm Description
Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications.
Arm Title
Experimental Arm (Arm 2)
Arm Type
Experimental
Arm Description
Consists of treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable (e.g. surgery, RFA, fractionated radiation, chemoradiation) if those are deemed to be preferable by the treating oncologists.
Intervention Type
Radiation
Intervention Name(s)
Palliative Radiotherapy
Intervention Description
Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications. Recommended dose fractionations in this arm will include 8 Gy in 1 fraction, 20 Gy in 5 fractions, and 30 Gy in 10 fractions.
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Other Intervention Name(s)
Cytotoxic Systemic Therapy
Intervention Description
Pre-specified based on the standard of care approach for that patient.
Intervention Type
Drug
Intervention Name(s)
Hormone therapy
Other Intervention Name(s)
Hormonal Systemic Therapy
Intervention Description
Pre-specified based on the standard of care approach for that patient.
Intervention Type
Drug
Intervention Name(s)
Immunotherapy
Intervention Description
Pre-specified based on the standard of care approach for that patient.
Intervention Type
Drug
Intervention Name(s)
Targeted Systemic Therapy
Intervention Description
Pre-specified based on the standard of care approach for that patient.
Intervention Type
Other
Intervention Name(s)
Observation
Intervention Description
Pre-specified based on the standard of care approach for that patient.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Ablative Radiotherapy
Intervention Description
The primary tumor may be treated with SABR or with other local modalities at the discretion of the treating team and/or the local multidisciplinary tumor board.
Preferred doses are 20 Gy in 1 fraction, 30 Gy in 3 fractions (every second day), and 35 Gy in 5 fractions (daily).
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
Treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable if those are deemed to be preferable by the treating oncologists.
The primary tumor may be treated with SABR or with other local modalities at the discretion of the treating team and/or the local multidisciplinary tumor board. Because of the convenience in using SABR for all lesions, non-SABR modalities should only be used if they are likely to provide a benefit over SABR.
Intervention Type
Other
Intervention Name(s)
Radiofrequency Therapy (RFA)
Intervention Description
Treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable if those are deemed to be preferable by the treating oncologists.
Intervention Type
Radiation
Intervention Name(s)
Fractionated Radiation
Intervention Description
Treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable if those are deemed to be preferable by the treating oncologists.
Tumors in the esophagus, stomach, small intestine or colon should be treated with either fractionated radiation or a lower SABR dose (e.g. 25 Gy in 5 fractions) to minimize the risk of perforation.
Primary Outcome Measure Information:
Title
Overall Survival
Description
Time from randomization to death from any cause, or date of last follow-up, whichever occurs first.
Time Frame
Approximately end of year 6 (Study Completion)
Secondary Outcome Measure Information:
Title
Quality of Life (QOL) assessed with the Functional Assessment of Cancer Therapy: General (FACT-G).
Time Frame
Quality of Life outcomes to be collected for the first 2 years (3, 6, 12, 18, 24 months)
Title
Quality of Life (QOL) assessed with the Functional Assessment of Cancer Therapy: The EuroQol 5-Dimension 5-Level (EQ-5D-5L).
Time Frame
Quality of Life outcomes to be collected for the first 2 years (3, 6, 12, 18, 24 months)
Title
Toxicity assessed by the Common Toxicity Criteria for Adverse Events (CTCAE) version 5 for each organ treated (e.g. liver, lung, bone).
Time Frame
Toxicity outcomes to be collected for the first 2 years (Last week of treatment, in 6 weeks, in 3, 6, 12, 18, 24 months)
Title
Time to next systemic therapy
Description
The time from randomization until commencement of any systemic anti-cancer therapy, or date of last follow-up, whichever occurs first.
Time Frame
From randomization to year 6 (study completion).
Title
Receipt of additional radiation during follow-up
Description
Will be collected for SABR (as a binary endpoint; yes/no), and non-SABR (yes/no).
Time Frame
During year 6 (follow-up year).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 years or older
Willing to provide informed consent
Karnofsky performance status > 60
Life expectancy > 6 months
Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.
Total number of metastases 1-10 at the time of enrollment, with a primary tumor also present
Restaging completed within 12 weeks prior to randomization (see section 5.1)
For patients receiving thoracic radiotherapy, the enrolling physician must confirm there are no computed tomography (CT) changes suggestive of fibrotic interstitial lung disease (ILD) (i.e. reticular changes, traction bronchiectasis, or honeycombing) reported on any prior CT scans. If any are present, the patient must be assessed by a respirologist to rule out ILD prior to enrollment.
Exclusion Criteria:
Serious medical comorbidities precluding radiotherapy. These include ILD in patients requiring thoracic radiation, Crohn's disease in patients where the gastrointestinal (GI) tract will receive radiotherapy, or ulcerative colitis where the bowel will receive radiotherapy and connective tissue disorders such as lupus or scleroderma.
For patients with liver metastases, moderate/severe liver dysfunction (Child Pugh B or C); please see the Child-Pugh score calculator.
Substantial overlap with a previously treated radiation volume. Prior radiotherapy in general is allowed, as long as the composite plan meets dose constraints herein. For patients treated with radiation previously, biological effective dose calculations should be used to equate previous doses to the tolerance doses listed in Appendix 1. All such cases must be discussed with a member of the study steering committee.
Malignant pleural effusion
Inability to treat all sites of disease
Brain metastasis > 3 cm in size or a total volume of brain metastases greater than 30 cc.
Metastasis in the brainstem
Clinical or radiologic evidence of spinal cord compression
Metastatic disease that invades any of the following: GI tract (including esophagus, stomach, small or large bowel), or skin
Pregnant or lactating women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Palma, MD, PhD
Phone
519-685-8650
Email
David.Palma@lhsc.on.ca
Facility Information:
Facility Name
BC Cancer - Centre for the North
City
Prince George
State/Province
British Columbia
ZIP/Postal Code
V2M 7E9
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Olson, MD, MSc
Facility Name
London Regional Cancer Program of the Lawson Health Research Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Palma, MD, PhD
Phone
519-685-8650
Email
David.Palma@lhsc.on.ca
First Name & Middle Initial & Last Name & Degree
David Palma, MD, PhD
Facility Name
Centre Hospitalier de l'Université de Montréal-CHUM
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 0C1
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Houda Bahig, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for Patients With Up to 10 Oligometastases and a Synchronous Primary Tumor.
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