Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Clinical summary
Summary
Stereotactic Ablative Radiotherapy (SABR) is a new radiation treatment that delivers high-dose, precise radiation to small tumors in 1-3 weeks of treatment. This new technique can potentially allow radiation treatments to be focused more precisely, and delivered more accurately than with older treatments. This improvement could help by reducing side effects and by improving the chance of controlling the cancer by more precisely treating the cancer.
Eligible participants will be randomly allocated to one of two treatment arms.
In the Active Comparator Arm, participants will receive standard of care, palliative radiotherapy, and chemotherapy at the discretion of the treating medical oncologist.
In the Experimental Arm, participants will receive SABR, and chemotherapy at the discretion of the treating medical oncologist.
Conditions
This trial is treating people with metastatic cancer
Eligibility
Inclusion
- Age 18 or older
- Willing to provide informed consent
- Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.
- ECOG performance status 0-1
-
Controlled primary tumor
a. defined as: at least 3 months since original tumor treated definitively, with no progression at primary site
- All sites of disease can be safely treated based on criteria below
- Maximum 3 metastases in any single organ system (i.e. lung, liver, brain, bone)
- Life expectancy >6 months
- Not a candidate for surgical resection at all sites: surgery to all sites not recommended by multidisciplinary team, or unfit or declining surgery
- Prior chemotherapy allowed but no systemic therapy 4 weeks prior to first fraction of radiotherapy, during radiotherapy, or for two weeks after last fraction
-
Patients with metastases that have been previously treated (e.g. prior resection, Radiofrequency Ablation (RFA) or radiotherapy):
a. If that previously treated metastasis is controlled on imaging, the patient is eligible for this study and that site does not need treatment
a. If that previously treated metastasis is NOT controlled on imaging:
- If the previous treatment was surgery, the patient is eligible if that site can be treated by SABR
- If the previous treatment was radiotherapy or RFA, the patient is ineligible.
- Patient presented at multidisciplinary tumor board or quality-assurance rounds.
Exclusion
- Serious medical comorbidities precluding radiotherapy
- Bone metastasis in a femoral bone
- Patients with 1-3 brain metastasis and no disease elsewhere (these patients should not be randomized but treated with stereotactic radiotherapy as per results of randomized trials)
- Prior radiotherapy to a site requiring treatment
- Complete response to first-line chemotherapy (i.e. no measurable target for SABR)
- Malignant pleural effusion
- Inability to treat all sites of active disease
- Clinical or radiologic evidence of spinal cord compression OR tumor within 3 mm of spinal cord on Magnetic Resonance Imaging (MRI).
- Dominant brain metastasis requiring surgical decompression
- Pregnant or lactating women
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 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
Lawson Health Research Institute
Scientific Title
Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic Tumors (SABR-COMET): A Randomized Phase II Trial
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