Completed and ongoing randomized clinical trials investigating the role of consolidative WBRT in patients with newly diagnosed PCNSL
| Trial, scientific group (clinicaltrials.gov ID) . | Recruitment . | Patients, n . | Eligibility criteria . | Control arm . | Intervention arm . | Primary end point . | Comments . |
|---|---|---|---|---|---|---|---|
| G-PCNSL-SG-1 | Completed | 551 | Newly diagnosed PCNSL; age ≥18 y; ECOG PS ≤3 | HD-MTX ± ifosfamide → WBRT 45 Gy | HD-MTX ± ifosfamide | OS | Several methodologic flaws, noninferiority margin not met; no definite conclusions can be drawn |
| IELSG32, International Extranodal Lymphoma Study Group (NCT01011920) | Completed | 219* and 118† | Newly diagnosed PCNSL; age 18–65 y (ECOG ≤ 3); age 65–70 y if ECOG ≤2 | Induction → WBRT 36 Gy | Induction treatment → HDC/ASCT | CRR* and PFS† | First randomization proved efficacy of MATRix regimen; both consolidation therapies (WBRT and HDC/ASCT) are effective |
| RTOG 1114, Radiation Therapy Oncology Group (NCT01399372) | Completed | 89 | Newly diagnosed PCNSL; age ≥18 y; ECOG PS ≤3 | R-MPV → HD-ARAC | R-MPV → WBRT 23.4 Gy → HD-ARAC | PFS | Estimated completion regarding primary end point is December 2022 |
| PRECIS, ANOCEF/GOELAMS (NCT00863460) | Completed | 140 | Newly diagnosed PCNSL; age 18–60 y | R-MBVP → R-HD-ARAC→ WBRT 40 Gy | R-MBVP → R-HD-ARAC → HDC/ASCT | 2-y PFS | Results reported as meeting abstract |
| Trial, scientific group (clinicaltrials.gov ID) . | Recruitment . | Patients, n . | Eligibility criteria . | Control arm . | Intervention arm . | Primary end point . | Comments . |
|---|---|---|---|---|---|---|---|
| G-PCNSL-SG-1 | Completed | 551 | Newly diagnosed PCNSL; age ≥18 y; ECOG PS ≤3 | HD-MTX ± ifosfamide → WBRT 45 Gy | HD-MTX ± ifosfamide | OS | Several methodologic flaws, noninferiority margin not met; no definite conclusions can be drawn |
| IELSG32, International Extranodal Lymphoma Study Group (NCT01011920) | Completed | 219* and 118† | Newly diagnosed PCNSL; age 18–65 y (ECOG ≤ 3); age 65–70 y if ECOG ≤2 | Induction → WBRT 36 Gy | Induction treatment → HDC/ASCT | CRR* and PFS† | First randomization proved efficacy of MATRix regimen; both consolidation therapies (WBRT and HDC/ASCT) are effective |
| RTOG 1114, Radiation Therapy Oncology Group (NCT01399372) | Completed | 89 | Newly diagnosed PCNSL; age ≥18 y; ECOG PS ≤3 | R-MPV → HD-ARAC | R-MPV → WBRT 23.4 Gy → HD-ARAC | PFS | Estimated completion regarding primary end point is December 2022 |
| PRECIS, ANOCEF/GOELAMS (NCT00863460) | Completed | 140 | Newly diagnosed PCNSL; age 18–60 y | R-MBVP → R-HD-ARAC→ WBRT 40 Gy | R-MBVP → R-HD-ARAC → HDC/ASCT | 2-y PFS | Results reported as meeting abstract |