Status:
ACTIVE_NOT_RECRUITING
Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic (1-3 Metastases) Cancer
Lead Sponsor:
British Columbia Cancer Agency
Collaborating Sponsors:
London Regional Cancer Program, Canada
The Alfred
Conditions:
Metastatic Tumors
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Stereotactic Ablative Radiotherapy (SABR) is a modern RT technique that delivers high doses of radiation to small tumor targets using highly conformal techniques. SABR is non-invasive and delivered on...
Detailed Description
TREATMENT PLAN 5.1.1 Standard Arm (Arm 1) Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of al...
Eligibility Criteria
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
- Lesion in femoral bone requiring surgical fixation
- Chemotherapy agents (cytotoxic, or molecularly targeted agents) used within the period of time commencing 2 weeks prior to radiation, lasting until 1 week after the last fraction for patients randomized to SABR
- Serious medical comorbidities precluding radiotherapy. These include interstitial lung disease in patients requiring thoracic radiation, Crohn's disease in patients where the GI tract will receive radiotherapy, and connective tissue disorders such as lupus or scleroderma.
- 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 conventional radiation previously, biological effective dose calculations should be used to equate previous doses to the tolerance doses listed below. All such cases should be discussed with one of the study PIs.
- Concurrent malignant cancer, or history of malignant cancers within the past 5 years
- Malignant pleural effusion
- History of poor lung function (if treating near lung)
- History of poor liver function (if treating near liver)
- Inability to treat all sites of disease
- Maximum size of 5 cm for lesions outside the brain, except:
- Bone metastases over 5 cm may be included, if in the opinion of the local PI it can be treated safely (e.g. rib, scapula, pelvis)
- Any brain metastasis \>3 cm in size or a total volume of brain metastases greater than 30 cc.
- Clinical or radiologic evidence of spinal cord compression, or epidural tumor within \<2 mm of the spinal cord. Patients can be eligible if surgical resection has been performed, but the surgical site counts toward the total of up to 8 lifetime metastases.
- Dominant brain metastasis requiring surgical decompression
- Pregnant or breastfeeding women
- Waivers to exclusion criteria will NOT be allowed.
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT03862911
Start Date
November 1 2019
End Date
December 31 2030
Last Update
November 28 2025
Active Locations (17)
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1
Cancer Care Griffith
Griffith, New South Wales, Australia
2
Riverina Cancer Care Centre
Wagga Wagga, New South Wales, Australia, 2650
3
Alfred Hospital
Melbourne, Victoria, Australia, 3004
4
Tom Baker Cancer Centre/Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada, T2N 4N2