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RecruitingLast updated: 18 March 2024

SABR-COMET-3: This study is comparing a modern radiation therapy technique to standard of care treatment in people with oligometastatic cancerPhase III Randomized Controlled Trial and Economic Evaluation of Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic (1-3 Metastases) Cancer

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 patients with a total number of 1-3 current metastases, and a maximum of 8 lifetime metastases

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

Not applicable

Trial Acronym

SABR-COMET-3

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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

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

  • 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.

Inclusion

  • Your cancer has spread to other parts of the body.

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.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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