Table 3.
United States Phase III Randomized Proton vs. Photon Clinical Trials Currently Active or Recruiting Patients
| Trial Name and ID no. | Study Design and Site | No. Pts | Intervention and Trial Period | Inclusion Criteria | Primary Endpoint |
|---|---|---|---|---|---|
| Pragmatic Randomized Trial of Proton vs. Photon Therapy for Patients With Non-Metastatic Breast Cancer: a Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial (NCT02603341) | Phase III, randomized Multicenter |
1278 | PBT or XRT 45–50.4 Gy(RBE) / 25–28 fx 2016-present |
Non-metastatic breast cancer with indication for including the internal mammary chain in regional-node irradiation | 10-year rate of major cardiovascular events |
| Phase III Randomized Trial Comparing Overall Survival After Photon Versus Proton Chemoradiotherapy for Inoperable Stage II-IIIB NSCLC (RTOG1308) (NCT01993810) | Phase III, randomized Multicenter |
330 | PBT or XRT for 35 fx with concurrent chemotherapy 2014-present |
Locally advanced non-small cell lung cancer | Overall survival Cardiac toxicity and lymphopenia |
| A Phase II Randomized Trial of Proton vs. Photon Therapy for Cognitive Preservation in patients With IDH Mutant, Low to Intermediate Grade Gliomas (NRG BN005) (NCT03180502) |
Phase II, randomized Multicenter |
120 | PBT or IMRT for 30 fx 2017-present |
IDH-mutant grade II or III glioma | Change in cognition per CTB COMP score |
| A Phase III Randomized Trial of Protons Versus Photons for Hepatocellular Carcinoma (NRG GI003) (NCT03186898) |
Phase III, randomized Multicenter |
186 | PBT or XRT for 5 or 15 fx 2017-present |
Unresectable or locally recurrent hepato-cellular cancer, Child-Turcotte-Pugh A or B7 | Overall survival |
| Phase III Randomized Trial of Proton Beam Therapy Versus Intensity-Modulated Photon Radiotherapy for the Treatment of Esophageal Cancer (GI006) (NC03801876) | Phase III, randomized Multicenter |
300 | PBT or IMRT 50.4 Gy(RBE) / 28 fx with concurrent chemotherapy |
Stage I-IVA esophageal cancer | Overall survival Incidence of grade ≥3 cardiopulmonary adverse events |
Abbreviations: PBT, proton therapy; XRT, photon radiotherapy; Gy(RBE), unit of dose for proton therapy; fx, fractions; IMRT, intensity-modulated radiation therapy; CBT COMP, Clinical Trial Battery Composite