Stereotactic Ablative Radiation Therapy for Comprehensive Treatment of 4-10 Oligometastatic Tumours

Official Title

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

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 Radiation Therapy (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 tumour and 4-10 metastatic lesions.

Trial Description

Primary Outcome:

• Overall Survival at Study Completion

• Progression-free Survival
• Time from randomization to development of new metastatic lesions
• Quality of Life as measured by the Functional Assessment of Cancer Therapy- General (FACT-G) questionnaire
• Quality of Life as measured by the EuroQOL Group EQ-5D-5L questionnaire
• Toxicity as measured by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
• Overall Survival at midpoint of Study

View this trial on ClinicalTrials.gov