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Closed (no longer recruiting)Last updated: 5 February 2024

SABR-COMET 10: This Phase III study is trying to understand the impact of Stereotactic Ablative Radiotherapy (SABR), compared to standard of care treatments in people with 4 to 10 metastatic cancer depositsA Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of 4-10 Oligometastatic Tumors (SABR-COMET 10)

Clinical summary

Summary

This is a randomised trial with experimental and active comparator arms. In the Experimental Arm, participants will receive Stereotactic Ablative Radiotherapy (SABR) plus standard of care treatment: chemotherapy, immunotherapy, hormones, or observation given at the discretion of the treating oncologist. SABR: total dose of radiation of fractions will depend on the site of disease. Doses are 20 Gy in 1 fraction, 30Gy in 3 fractions (every 2 days), or 35 in 5 fractions (daily). In the Active Comparator Arm, participants will receive standard of care treatment: palliative radiotherapy, chemotherapy, immunotherapy, hormones, or observation, at the discretion of the treating oncologist. Palliative 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.

Conditions

This trial is treating patients with metastatic cancers.

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

III

Trial Acronym

SABR-COMET 10

More information

Trial Identifiers

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Trial sponsor

David Palma

Scientific Title

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

Eligibility

Inclusion

  • 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

  • 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

Inclusion

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

Exclusion

  • 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.

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