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NCT Number: NCT03721341

Stereotactic Ablative Radiotherapy for Comprehensive Treatment of 4-10 Oligometastatic Tumors

In patients with a limited oligometastatic burden (cancer has spread but is not yet considered metastatic), emerging evidence suggests that treatment of all sites of disease with ablative therapies can improve patient outcomes, including overall- and progression-free survival. The application of Stereotactic Ablative Radiotherapy (SABR) for patients with 4-10 metastatic deposits appears promising, yet it is unclear if all patients with greater than 3 oligometastatic lesions benefit from ablative therapies in terms of improved Overall Survival (OS), Progression Free Survival (PFS), or quality of life. The purpose of this study is to assess the impact of SABR, compared to standard of care treatment, on overall survival, oncologic outcomes, and quality of life in patients with a controlled primary tumor and 4-10 metastatic lesions.

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Key information

Conditions

Metastatic Tumors Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alfred Health, Melbourne, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 or older
  • Willing to provide informed consent
  • Karnofsky performance score greater than 60
  • Life expectancy greater than 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
  • Total number of metastases 4-10
  • All sites of disease can be safely treated based on a pre-plan

Exclusion criteria

  • 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.
  • For patients with liver metastases, moderate/severe liver dysfunction (Child Pugh B or C)
  • 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 radiation previously, biological effective dose calculations should be used to equate previous doses to the tolerance doses listed below. All such cases must be discussed with one of the study PIs.
  • Malignant pleural effusion
  • Inability to treat all sites of disease
  • Any single metastasis greater than 5 cm in size.
  • Any brain metastasis greater than 3 cm in size or a total volume of brain metastases greater than 30 cc.
  • Metastasis in the brainstem
  • Clinical or radiologic evidence of spinal cord compression
  • Dominant brain metastasis requiring surgical decompression
  • Metastatic disease that invades any of the following: GI tract (including esophagus, stomach, small or large bowel), mesenteric lymph nodes, or skin
  • Pregnant or lactating women

Treatment and study plan

Palliative Radiation

Radiation

Investigators should follow the principles of palliative radiotherapy as per the individual institution in order to alleviate symptoms or prevent complications. If radiotherapy is indicated, recommended doses are 8 Gy in 1 fraction, 20 Gy in 5 fractions, and 30 Gy in 10 fractions.

Other names: Palliative Radiotherapy

Chemotherapy

Drug

Chemotherapy may be given as indicated.

Immunotherapy

Drug

Immunotherapy may be given as indicated.

Hormones

Drug

Hormones may be given as indicated.

observation

Other

Observation only is acceptable if this is the standard practice.

stereotactic ablative radiotherapy

Radiation

Total dose of radiation and number of fractions will depend on the site of disease. Doses are 20 Gy in 1 fraction, 30 Gy in 3 fractions (every 2 days), or 35 Gy in 5 fractions (daily).

Primary outcomes

  1. Overall Survival at Study Completion

    Time frame: At approximately end of year 6 (study completion)

    Time from randomization to death from any cause.

Secondary outcomes

  1. Progression-free Survival

    Time frame: At approximately year 3, and end of year 6 (study completion)

    Time from randomization to disease progression at any site or death.

  2. Time from randomization to development of new metastatic lesions

    Time frame: At approximately end of year 6 (study completion)

    New metastatic lesions will be detected using computed tomography, magnetic resonance imaging, and/or bone scans.

  3. Quality of Life as measured by the Functional Assessment of Cancer Therapy- General (FACT-G) questionnaire

    Time frame: At approximately end of year 6 (study completion)

  4. Quality of Life as measured by the EuroQOL Group EQ-5D-5L questionnaire

    Time frame: At approximately end of year 6 (study completion)

  5. Toxicity as measured by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

    Time frame: End of years 1, 2, 3, 4, 5, and 6 (study completion)

  6. Overall Survival at midpoint of Study

    Time frame: At approximately year 3 (midpoint)

Sponsors and collaborators

Lead sponsor

David Palma

Other

Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Beaston West of Scotland Cancer Centre
  • British Columbia Cancer - Centre for the North
  • London Health Sciences Centre

Registry information

Official study title

A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of 4-10 Oligometastatic Tumors (SABR-COMET 10)

Acronym: SABR-COMET 10

Important dates

Study start
2019
Primary completion
2029
Study completion
2029
First posted
Oct 26, 2018
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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