At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓Histologically confirmed malignancy with metastatic disease on imaging
- ✓1-10 metastases at enrollment with primary tumor present
- ✓10 or fewer lifetime metastases from the cancer
- ✕Serious medical comorbidities precluding radiotherapy including ILD, Crohn's disease, ulcerative colitis, lupus, or scleroderma
- ✕Moderate/severe liver dysfunction (Child Pugh B or C) in patients with liver metastases
- ✕Substantial overlap with previously treated radiation volume
- ✕Malignant pleural effusion
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for Patients With Up to 10 Oligometastases and a Synchronous Primary Tumor.
In Brief
A Phase 3 clinical trial evaluating Palliative Radiotherapy, Chemotherapy, and 8 other interventions for Metastatic Tumor. Currently recruiting, targeting 180 participants across 5 sites in 2 countries.
Detailed Summary
This study is a phase III multi-institutional randomized trial. Patients will be randomized in a 1:2 ratio between current standard of care treatment (Arm 1) vs. standard of care treatment + SABR (Arm 2) to sites of known disease. Patients will be stratified by two of the strongest prognostic factors, based on a large multi-institutional analysis3: histology (Group 1: hormone-sensitive prostate cancer, breast, or renal; Group 2: all others), and number of metastases (Group 1: 1-3; Group 2: 4-10).
Study Details
Timeline
Interventions
Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications. Recommended dose fractionations in this arm will include 8 Gy in 1 fraction, 20 Gy in 5 fractions, and 30 Gy in 10 fractions.
Pre-specified based on the standard of care approach for that patient.
Pre-specified based on the standard of care approach for that patient.
Pre-specified based on the standard of care approach for that patient.
Pre-specified based on the standard of care approach for that patient.
Pre-specified based on the standard of care approach for that patient.
The primary tumor may be treated with SABR or with other local modalities at the discretion of the treating team and/or the local multidisciplinary tumor board. Preferred doses are 20 Gy in 1 fraction, 30 Gy in 3 fractions (every second day), and 35 Gy in 5 fractions (daily).
Treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable if those are deemed to be preferable by the treating oncologists. The primary tumor may be treated with SABR or with other local modalities at the discretion of the treating team and/or the local multidisciplinary tumor board. Because of the convenience in using SABR for all lesions, non-SABR modalities should only be used if they are likely to provide a benefit over SABR.
Treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable if those are deemed to be preferable by the treating oncologists.
Treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable if those are deemed to be preferable by the treating oncologists. Tumors in the esophagus, stomach, small intestine or colon should be treated with either fractionated radiation or a lower SABR dose (e.g. 25 Gy in 5 fractions) to minimize the risk of perforation.