Table 1.
Major clinical trials in local treatment for BCBM.
| Treatment Type | Patients’ Population | Author | Trial Name (NCT Number) |
Phase | Primary Endpoint |
|---|---|---|---|---|---|
| Surgery plus WBRT vs. WBRT | Single BM | Patchell et al. [39] | III | OS | |
| Surgery plus WBRT vs. Surgery alone | Single BM | Patchell et al. [40] | III | Recurrence of tumor in the brain | |
| Postoperative SRS vs. WBRT | Single BM (a resected BM and a resection cavity less than 5.0cm) | Brown et al. [41] | NCCTG N107C/CEC·3 (NCT01372774) |
III | Cognitive-deterioration-free survival and OS |
| Salvage SRS vs. postoperative WBRT | 1 to 4 resected BMs with only one lesion > 3 cm | Kayama et al. [42] | JCOG0504 | III | OS |
| WBRT alone vs. WBRT followed by SRS | 1 to 3 BMs | Andrews et al. [43] | RTOG9508 (NCT00002708) |
III | OS |
| SRS or Surgery with/without WBRT | 1 to 3 BMs | Kocher et al. [44] | EORTC 22952-26001 (NCT00002899) |
III | Time to PS deterioration more than 2 |
| SRS alone vs. SRS plus WBRT | 1 to 3 BMs | Brown et al. [45] | (NCT00377156) | III | Cognitive deterioration at 3 months |
| SRS plus WBRT vs. SRS alone | 1 to 4 BMs, each under than 3 cm | Aoyama et al. [46] | (C000000412) *,1 | III | OS |
| SRS for 2–4 BMs vs. 5–10 BMs | Patients with BMs who received SRS | Yamamoto et al. [47] | JLGK0901 (UMIN000001812) *,1 |
III | OS |
| SRS vs WBRT | 4–15 untreated non-melanoma BMs | Li et al. [48] | (NCT01592968) | III | Local control rate and proportion of patients with neurocognitive decline at 4 months |
| SRS vs HA-WBRT | 5–20 BMs | (Recruiting) | (NCT03075072) | III | Quality of life |
| HA-WBRT | BM outside a 5 mm margin around either hippocampus | Gondi et al. [49] | RTOG 0933 (NCT01227954) |
II | Cognitive function |
Abbreviations: BC, breast cancer; MBC, metastatic breast cancer; BM, brain metastasis; BCBM, breast cancer brain metastasis; WBRT, whole brain radiation therapy; SRS, stereotactic radiosurgery; HA-WBRT, hippocampal-avoidance whole brain radiation therapy; OS, overall survival; PFS, progression-free survival; PS, performance status. *,1 UMIN Clinical Trials Registry (UMIN-CTR) identifier. UMIN-CTR is an authorized clinical trial registry of the International Committee of Medical Journal Editors.