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

Last updated: December 12, 2023
Sponsor: David Palma
Overall Status: Active - Not Recruiting

Phase

3

Condition

Neoplasm Metastasis

Treatment

Immunotherapy

Chemotherapy

Palliative Radiation

Clinical Study ID

NCT03721341
SABR-COMET 10
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 treateddefinitively, 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

Exclusion Criteria:

  • Serious medical comorbidities precluding radiotherapy. These include interstitial lungdisease in patients requiring thoracic radiation, Crohn's disease in patients wherethe GI tract will receive radiotherapy, and connective tissue disorders such as lupusor scleroderma.
  • For patients with liver metastases, moderate/severe liver dysfunction (Child Pugh B orC)
  • Substantial overlap with a previously treated radiation volume. Prior radiotherapy ingeneral is allowed, as long as the composite plan meets dose constraints herein. Forpatients treated with radiation previously, biological effective dose calculationsshould be used to equate previous doses to the tolerance doses listed below. All suchcases 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 metastasesgreater 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

Study Design

Total Participants: 204
Treatment Group(s): 6
Primary Treatment: Immunotherapy
Phase: 3
Study Start date:
February 22, 2019
Estimated Completion Date:
January 31, 2029

Connect with a study center

  • Alfred Health

    Melbourne, Victoria 3181
    Australia

    Site Not Available

  • BC Cancer Agency, Vancouver Island Centre

    Victoria, British Columbia V8R 4X1
    Canada

    Site Not Available

  • Nova Scotia Health Authortiy

    Halifax, Nova Scotia B3S 0H6
    Canada

    Site Not Available

  • Grand River Hospital

    Kitchener, Ontario N2G 1G3
    Canada

    Site Not Available

  • London Regional Cancer Program of the Lawson Health Research Institute

    London, Ontario N6A 5W9
    Canada

    Site Not Available

  • Trillium Health Partners-Credit Valley Hospital

    Mississauga, Ontario L5M 2N1
    Canada

    Site Not Available

  • Niagra Health System

    St. Catharines, Ontario L2S 0A9
    Canada

    Site Not Available

  • Health Sciences North

    Sudbury, Ontario P3E 5J1
    Canada

    Site Not Available

  • University Health Network

    Toronto, Ontario M5G 2C4
    Canada

    Site Not Available

  • Centre hospitalier de l'Université de Montréal-CHUM

    Montréal, Quebec H2X 0C1
    Canada

    Site Not Available

  • VU University Medical Centre

    Amsterdam,
    Netherlands

    Site Not Available

  • University Hospital of Zürich

    Zürich, 8091
    Switzerland

    Site Not Available

  • Western General Hospital

    Edinburgh, EH4 2XU
    United Kingdom

    Site Not Available

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN
    United Kingdom

    Site Not Available

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