Table 2.
Principal Investigator | NCT | Disease | Design | Definition | Target Accrual | Intervention | Outcome |
---|---|---|---|---|---|---|---|
Dirix, P. | NCT03486431 | Mixed | Prospective, Phase 1 | ≤3 lesions | 99 | SABR | Primary: DLT Secondary: Median PFS Local Control Rate |
Bourgier, C. | NCT02089100 | Breast | Randomized, Phase 3, Multi-Center | ≤5 lesions | 280 | SABR vs best supportive care | PFS |
De Rose, F. Comito, T. | NCT02581670 | Breast *Lung/Liver Metastases |
Non-Randomized Phase II | 1–4 Lesions | 40 | SBRT | Primary: Local Control, Toxicity Secondary: PFS, OS |
Chmura, S. | NCT02364557 | Breast | Randomized Phase II/III | 1–4 Lesions | 402 | Systemic Therapy +/− SBRT | Primary: PFS, OS Secondary: Presence of CTC (baseline, after treatment); levels of ctDNA; incidence AE’s; appearance of new metastases |
Khoo, V. | NCT02759783 | Breast, Prostate, NSCLC | Randomized Phase II/III | ≤3 Lesions | 245 | Standard of Care +/− SBRT | Primary: PFS Secondary: OS, Local Control, Toxicity |