Table 1.
Currently ongoing clinical trials investigating RT for oligometastatic disease.
| NCT identifier | Study phase | Patients estimated | Study population | Standard arm | Experimental arm | Primary endpoint | ||
|---|---|---|---|---|---|---|---|---|
| Upfront focal RT | ||||||||
| NCT04805255 (Chang Gung Memorial Hospital) | NA (Cohort study) | 135 | 1-3 BMs ≤4.0 cm diameter | – | SRT (30-35 Gy/5 fx) | Cognitive-deterioration-free survival | ||
| NCT02054689 (University of Pittsburgh) | I | 25 | Large BM (3-5 cm), maximum 3 lesions | – | SRT (24 to 36 Gy in 3 fx, 8-12 Gy/fx) | MTD | ||
| NCT03726359 (Albert Einstein College of Medicine) | I | 43 | Large BM (3-5 cm) | – | SRT (starting dose 35 Gy/5 fx every other day) | MTD | ||
| NCT03412812 (University of Alabama at Birmingham) | I | 60 | Large BMs (2.1-6 cm) | – | SRT (5 fx) | MTD | ||
| NCT02747303 (University of Chicago) | II | 166 | 1-5 BMs ≤3.0 cm diameter | SRS | 0 mm GTV-PTV margins SRS | PFS | ||
| NCT03697343 (University of Erlangen-Nürnberg Medical School) | III | 302 (not yet recruiting) | Large BMs (2-4 cm) maximum 4 lesions | SRS | SRT | Time to local progression | ||
| Adjuvant SRS/SRT | ||||||||
| NCT03285932 (ESTRON) | II | 50 | Resected BM and ≤10 unresected lesions | WBRT | SRT (35 Gy/7fx) + SRS/SRT for any unresected lesions | Neurological PFS | ||
| NCT03561896 (Oncology Institute of Southern Switzerland) | II | 60 | Resected BM | SRS | IGRT (SRT) | Relapse rate | ||
| NCT04114981 (Alliance) | III | 208 | Resected BMs | SRS | SRT | Surgical bed recurrence-free survival | ||
| Neoadjuvant SRS | ||||||||
| NCT03163368 (Cedars-Sinai Medical Center) | I | 25 | Resectable BMs | – | Neoadjuvant SRS dose escalation | MTD | ||
| NCT01891318 (Case Comprehensive Cancer Center) | I-II | 36 | Resectable BMs | – | Neoadjuvant SRS | MTD, LC | ||
| NCT04503772 (Centre Jean Perrin) | II | 70 | Resectable BMs | – | Neoadjuvant SRT (33 Gy/3 fx at the isocenter) | 6mo-LC | ||
| NCT04422639 (University of Arkansas) | II | 104 | Resectable BMs | Adjuvant SRS/SRT | Neoadjuvant SRS/SRT | Time to CNS Composite Event (LR, symptomatic RN, LMD) | ||
| NCT03741673 (MDACC) | III | 86 | Resectable BMs | Adjuvant SRS | Neoadjuvant SRS | LMD free rate | ||
| NCT03750227 (Mayo Clinic) | III | 140 | Resectable BMs | Adjuvant SRS | Neoadjuvant SRS | CNS composite endpoint event | ||
| NCT04474925 (AHS Cancer Control Alberta) | III | 88 (not yet recruiting) | Resectable BMs | Adjuvant SRS | Neoadjuvant SRS | LC | ||
NA, not applicable; fx, fractions; MTD, Maximum Tolerated Dose; PFS, Progression Free Survival; LR, Local Relapse; LMD, LeptoMeningeal Dissemination; RN, Radionecrosis; CNS, Central Nervous System.