Completed and ongoing randomized clinical trials investigating the role of WBRT in newly diagnosed primary CNS lymphoma
| Investigator/trial . | Year . | Patients . | Eligibility criteria . | Control arm . | Intervention arm . | Outcome . | Comment . |
|---|---|---|---|---|---|---|---|
| Thiel et al (G-PCNSL-SG-1)6 | 2010 | N = 551 | Newly diagnosed PCNSL,≥18 y, KPS ECOG ≤3 | HD-MTX (ifosfamide) + WBRT | HD-MTX (ifosfamide) | Median OS 32.4 (WBRT) vs 37.1 mo; median PFS 18.3 (WBRT) vs 11.9 mo | Trial had several methodological flaws, non-inferiority margin not met |
| IELSG 32 (#NCT01011920) | Ongoing | N = 219 (1st randomization), N = 118 (2nd randomization) | Newly diagnosed PCNSL,18 to 65 y (ECOG 0 to 3), up to 70 y if ECOG ≤2 | Induction treatment followed by WBRT 36 ± 9 Gy | Induction treatment followed by HDT-ASCT with carmustine and thiotepa | Primary end point is 2 y event-free survival | First randomization proofed efficacy of rituximab. Results from 2nd randomization are pending |
| RTOG 1114 (#NCT01399372) | Ongoing | N = 89 | Newly diagnosed PCNSL,≥18 y, KPS ECOG ≤3 | Sequential R-MPV and HD-AraC | Sequential R-MPV, lower-dose WBRT (23.4 Gy), andHD-AraC | Primary end point is PFS | Recruitment complete, results pending |
| PRECIS (#NCT00863460) | Ongoing | N = 140 | Newly diagnosed PCNSL,≥18 to 60 y | Sequential R-MBVP and R-HD-AraC followed by 40 Gy WBRT | Sequential R-MBVP and R-HD-AraC, followed byHDT-ASCT with thiotepa, busulfan, and cyclophosphamide | Primary end point is 2 y PFS | Estimated completion of recruitment, February 2017 |
| Investigator/trial . | Year . | Patients . | Eligibility criteria . | Control arm . | Intervention arm . | Outcome . | Comment . |
|---|---|---|---|---|---|---|---|
| Thiel et al (G-PCNSL-SG-1)6 | 2010 | N = 551 | Newly diagnosed PCNSL,≥18 y, KPS ECOG ≤3 | HD-MTX (ifosfamide) + WBRT | HD-MTX (ifosfamide) | Median OS 32.4 (WBRT) vs 37.1 mo; median PFS 18.3 (WBRT) vs 11.9 mo | Trial had several methodological flaws, non-inferiority margin not met |
| IELSG 32 (#NCT01011920) | Ongoing | N = 219 (1st randomization), N = 118 (2nd randomization) | Newly diagnosed PCNSL,18 to 65 y (ECOG 0 to 3), up to 70 y if ECOG ≤2 | Induction treatment followed by WBRT 36 ± 9 Gy | Induction treatment followed by HDT-ASCT with carmustine and thiotepa | Primary end point is 2 y event-free survival | First randomization proofed efficacy of rituximab. Results from 2nd randomization are pending |
| RTOG 1114 (#NCT01399372) | Ongoing | N = 89 | Newly diagnosed PCNSL,≥18 y, KPS ECOG ≤3 | Sequential R-MPV and HD-AraC | Sequential R-MPV, lower-dose WBRT (23.4 Gy), andHD-AraC | Primary end point is PFS | Recruitment complete, results pending |
| PRECIS (#NCT00863460) | Ongoing | N = 140 | Newly diagnosed PCNSL,≥18 to 60 y | Sequential R-MBVP and R-HD-AraC followed by 40 Gy WBRT | Sequential R-MBVP and R-HD-AraC, followed byHDT-ASCT with thiotepa, busulfan, and cyclophosphamide | Primary end point is 2 y PFS | Estimated completion of recruitment, February 2017 |
ECOG, Eastern Cooperative Oncology Group; Gy, Gray; HDT-ASCT, high-dose therapy with ASCT; IELSG, International Extranodal Lymphoma Study Group; KPS, Karnofsky performance status; R-MBVP, rituximab/HD-MTX/carmustine/etoposide/HD-AraC; R-MPV, rituximab/HD-MTX/procarbazine/vincristine; RTOG, Radiation Therapy Oncology Group.