NCT03721341

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: David Palma · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Tumors

Interventions

Type	Name	Description
RADIATION	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.
DRUG	Chemotherapy	Chemotherapy may be given as indicated.
DRUG	Immunotherapy	Immunotherapy may be given as indicated.
DRUG	Hormones	Hormones may be given as indicated.
OTHER	Observation	Observation only is acceptable if this is the standard practice.
RADIATION	Stereotactic Ablative Radiotherapy	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).

Timeline

• Start date: 2019-02-22
• Primary completion: 2029-01-01
• Completion: 2029-01-01
• First posted: 2018-10-26
• Last updated: 2025-09-18

Locations

14 sites across 5 countries: Australia, Canada, Netherlands, Switzerland, United Kingdom