A Phase 3 interventional study of Palliative Radiation and Chemotherapy in Metastatic Tumors, sponsored by David Palma. Active, not recruiting at 14 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by David Palma · Phase 3, Interventional, and Treatment
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.
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's enrollment of 204 is above the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →David Palma is the lead sponsor of 6 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard of care treatment: palliative radiotherapy, chemotherapy, immunotherapy, hormones, or observation, is at the discretion of the treating oncologist.
Radiation: Palliative Radiation · Drug: Chemotherapy · Drug: Immunotherapy · Drug: Hormones · Other: Observation
Stereotactic ablative radiotherapy, plus standard of care treatment: chemotherapy, immunotherapy, hormones, or observation given at the discretion of the treating oncologist.
Drug: Chemotherapy · Drug: Immunotherapy · Drug: Hormones · Other: Observation · Radiation: Stereotactic Ablative Radiotherapy
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.
Also known as: Palliative Radiotherapy
Chemotherapy may be given as indicated.
Immunotherapy may be given as indicated.
Hormones may be given as indicated.
Observation only is acceptable if this is the standard practice.
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).
Overall Survival at Study Completion
Time from randomization to death from any cause.
Time frame: At approximately end of year 6 (study completion)
Progression-free Survival
Time from randomization to disease progression at any site or death.
Time frame: At approximately year 3, and end of year 6 (study completion)
Time from randomization to development of new metastatic lesions
New metastatic lesions will be detected using computed tomography, magnetic resonance imaging, and/or bone scans.
Time frame: At approximately end of year 6 (study completion)
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)
Quality of Life as measured by the EuroQOL Group EQ-5D-5L questionnaire
Time frame: At approximately end of year 6 (study completion)
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)
Overall Survival at midpoint of Study
Time frame: At approximately year 3 (midpoint)
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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David Palma