Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Trial acronym
SABR-COMET-3
Clinical summary
Summary
Stereotactic Ablative Radiotherapy (SABR) is a modern radiation therapy (RT) technique that delivers high doses of radiation to small tumour targets using highlighly conformal techniques. SABR is non-invasive and is delivered on an outpatient basis.
The purpose of this study is to compare the effect of SABR to standard of care. An integrated economic evaluation will also be undertaken to determine the economic benefits of this treatment.
Eligible participants will be randomly assigned to one of two treatment arms.
In the Active Comparator Arm (Arm 1), participants will receive standard of care, palliative radiotherapy and chemotherapy at the discrtion of the treating medical oncologist.
In the Experimental Arm (Arm 2), participants will receive SABR and chemotherapy at the discrtion of the treating medical concologist.
Conditions
This trial is treating people with a total number of 1-3 current metastases, and a maximum of 8 lifetime metastases
Eligibility
Inclusion
- Total number of 1-3 current metastases, and a maximum 8 lifetime metastases
- Age 18 or older
- Willing to provide informed consent
- ECOG score 0-2
- Life expectancy >6 months
- Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.
-
Controlled primary tumor
- defined as: at least 3 months since original tumor treated definitively, with no progression at primary site (can be considered controlled if no evidence of the primary tumour on imaging)
- A history and physical exam, including ECOG performance status, performed within 6 weeks prior to trial enrollment
- Not suitable for resection at all sites or decline surgery
- Patient has had a CT chest, abdomen and pelvis or PET-CT within 8 weeks prior to enrollment, and within 12 weeks prior to treatment(if randomized to SABR). CT neck as clinically indicated.
- Patient has had a nuclear bone scan (if no PET-CT) within 8 weeks prior to enrollment, and within 12 weeks prior to treatment(if randomized to SABR)
- If solitary lung nodule for which biopsy is unsuccessful or not possible, patient has had an FDG PET scan or CT (chest, abdomen, pelvis) and bone scan within 8 weeks prior to enrollment, and with 12 weeks prior to treatment (if randomized to SABR). CT neck as clinically indicated.
- If colorectal primary with rising CEA, but equivocal imaging, patient has had an FDG PET scan within 8 weeks prior to enrollment, and within 12 weeks prior to treatment(if randomized to SABR)
- Patient has had CT or MRI brain imaging if primary has a propensity for CNS metastasis within 8 weeks prior to enrollment, and within 12 weeks prior to treatment(if randomized to SABR)
- Patient is judged able to:
- Maintain a stable position during therapy
- Tolerate immobilization device(s) that may be required to deliver SABR safely
- Negative pregnancy test for Women of Child-Bearing potential (WOCBP) within 4 weeks of RT start date
- Patient is able and willing to complete the quality of life questionnaires, and other assessments that are a part of this study, via paper or online using REDCap (if email address is provided by participant on the informed consent)
Waivers to the inclusion criteria will NOT be allowed.
Exclusion
Waivers to exclusion criteria will NOT be allowed.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
British Columbia Cancer Agency
Scientific Title
Phase III Randomized Controlled Trial and Economic Evaluation of Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic (1-3 Metastases) Cancer
Get Support
You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.
Know more about Peer Connect
If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.
Get support
Learn more about clinical trials through this collection of resources in languages other than English.
View information