Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic (1-3 Metastases) Cancer

NCT03862911 | Active Not Recruiting DMC

• 1 other identifier: SABR-COMET-3
• Study Type: interventional
• Target: 330
• Locations: 4 countries
• Sites: 17

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 an outpatient basis. The purpose of this study is to compare the effect of SABR, relative to standard of care (SOC) alone, on overall survival, progression-free survival, toxicity, and quality of life. An integrated economic evaluation will determine the cost per quality of life year gained using SABR (vs. SOC) and a translational component will enable identification of predictive/prognostic biomarkers of the oligometastatic state.

Conditions

Metastatic Tumors

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Time from randomization to death from any cause

  At approximately end of year 5 (study completion)

Secondary Outcomes (6)

• Side effects

  At 6 weeks, 3 months, 6 months, and every 6 months post treatment for years 1 and 2. At approximately end of years 3, 4, and 5.

• Progression-free survival (PFS)

  At 6 weeks, 3 months, 6 months, and every 6 months post treatment for years 1 and 2. At approximately end of years 3, 4, and 5.

• Patient-reported quality of life (QoL)

  At baseline, 6 weeks, 3 months, 6 months, and every 6 months post treatment for years 1 and 2. At approximately end of years 3, 4, and 5.

• Health-related quality of life (HRQoL) questionnaire

  At baseline, 3 months, 6 months, and every 6 months post treatment for years 1 and 2. At approximately end of years 3, 4, and 5.

• Resource Utilization (Patient and Provider Reported)

  At 3 months, 6 months, and every 6 months post treatment for years 1 and 2. At approximately end of years 3, 4, and 5.

Study Arms (2)

Standard of Care Treatment (Arm 1)

ACTIVE COMPARATOR

Standard of care, palliative radiotherapy, and chemotherapy at the discretion of the treating medical oncologist

Radiation: palliative radiotherapy

Stereotactic Arm (Arm 2)

EXPERIMENTAL

Stereotactic ablative radiotherapy, and chemotherapy at the discretion of the treating medical oncologist

Radiation: Stereotactic ablative radiotherapy

Interventions

palliative radiotherapy RADIATION

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. Patients in this arm should not receive stereotactic doses or radiotherapy boosts. Recommended dose fractionations in this arm will include 8 Gy in 1 fractions, 20 Gy in 5 fractions, and 30 Gy in 10 fractions.

Standard of Care Treatment (Arm 1)

Stereotactic ablative radiotherapy RADIATION

Lung: Tumors 5 cm or less surrounded by lung parenchyma 48 Gy/4#, or 54 Gy/3#, daily or every second day Within 2 cm of mediastinum or brachial plexus 60 Gy/8#, daily Bone: Any bone 35 Gy/5#, or 24 Gy/2#, daily Brain: Stereotactic lesions (no whole brain RT) \<2cm 20-24 Gy/1#, once 2-3 cm 18 Gy/1#, once Metastases only: 35Gy/5# to PTV, daily Whole brain + Mets: 35Gy to metastases, daily 20 Gy whole brain, daily Liver: 54 Gy/3#, every second day Adrenal/Pancreas: 40 Gy/5# / 35Gy/7#, daily Lymph Node: 40 Gy/5#, daily

Stereotactic Arm (Arm 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• British Columbia Cancer Agency: lead
• London Regional Cancer Program, Canada: collaborator
• The Alfred: collaborator
• Beacon Hospital, Ireland: collaborator
• Cancer Trials Ireland: collaborator
• Cancer Research UK Edinburgh Centre: collaborator
• Bon Secours Cork Cancer Centre: collaborator
• UPMC Hillman Cancer Centre: collaborator
• Beatson West of Scotland Cancer Centre: collaborator
• Tom Baker Cancer Centre: collaborator
• Walker Family Cancer Centre: collaborator
• Riverina Cancer Care Centre: collaborator
• Aberdeen Royal Infirmary: collaborator

Study Sites (17)

Cancer Care Griffith

Griffith, New South Wales, Australia

Location

Riverina Cancer Care Centre

Wagga Wagga, New South Wales, 2650, Australia

Location

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Tom Baker Cancer Centre/Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

BC Cancer

Kelowna, British Columbia, V1Y 5L3, Canada

Location

BC Cancer - Prince George

Prince George, British Columbia, V2M 7E9, Canada

Location

BC Cancer

Surrey, British Columbia, Canada

Location

BC Cancer

Vancouver, British Columbia, Canada

Location

BC Cancer

Victoria, British Columbia, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

Walker Family Cancer Centre

Saint Catharines, Ontario, L2S 0A9, Canada

Location

St. Luke's Radiation Oncology Network

Rathgar, Dublin, 6, Ireland

Location

Beacon Hospital

Dublin, Sandyford, D18 AK68, Ireland

Location

Bon Secours Radiotherapy Cork in partnership with UPMC Hillman Cancer Centre

Cork, Ireland

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, United Kingdom

Location

Edinburgh Cancer Centre

Edinburgh, Scotland, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

Location

Related Publications (16)

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MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert A Olson, MD, MSc, FRCPC

  BC Cancer Prince George

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist & Department Head Radiation Oncology & Developmental Radiotherapeutics

Model Details: This study is a phase III multicentre randomized trial. Subjects 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. Subjects will be stratified by two of the strongest prognostic factors, based on a large multi-institutional analysis: histology (Group 1: prostate, breast, or renal; Group 2: all others), and disease-free interval (defined as time from diagnosis of primary tumor until first detection of the metastases being treated on this trial; divided as ≤2 years vs \>2 years).

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: March 5, 2019
• Study Start: November 1, 2019
• Primary Completion (Estimated): November 24, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 29, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (8); GB (3); AU (3); IE (3)