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. 2023 Jan 30;11(1):28–38. doi: 10.14791/btrt.2022.0046

Table 2. Clinical trials of average risk medulloblastoma.

Study (reference) No. of patients Cohort criteria Study outcome Radiation dose (Gy) Chemotherapy Survival
CCG 9892 [37] 65 3–10 yr, M0, R0 Non-randomized trial, feasibility of reduced dose CSI (23.4 Gy) and adjuvant CT CSI 23.4/PF 55.8 VCR during RT, CCNU/CDDP/VCR 5-yr PFS 79%
SIOP PNET3 [35] 179 (pre-RT CT 90, RT alone 89) 3–16 yr, M0 Randomized trial, pre-RT vs. RT alone (outcome of CT after surgery and before RT) CSI 35/PF 55 None vs. VCR, VP, alternating CBP and CPM 5-yr EFS 67.0% (pre-RT CT 74.2% vs. RT alone 59.7%)
SJMB-96 [45] (average risk arm) 86 3–21 yr M0, R0 Non-randomized trial, 5-yr EFS CSI 23.4/PF 36/TB 55.8 CPM, CDDP, VCR+SCR (4 cycles) 5-yr EFS 83%
HIT-SIOP 169 4–21 yr, except Randomized trial evaluating STRT vs. HFRT Conventional RT CSI 23.4/PF 54
HFRT CSI 36/PF 60
VCR during RT; adjuvant CDDP, CCNU, VCR 8 cycles 5-yr EFS 77% for STRT, 78% for conventional RT group 78%
PNET4 [39] 169 LC/A histology
COG A9961 [36] A 193
B 186
3–21 yr, M0 or R0 Randomized trial evaluating adjuvant
CPM vs. CCNU based chemo
CSI 23.4/PF 55.8 A: CCNU, CDDP, VCR
B: CPM, CDDP, VCR
A: 5-yr EFS 81%
B: 5-yr EFS 86%
SJMB-03 [40] 227 3–21 yr, M0, GTR or NTR (R0) Non-randomized trial, evaluating dose-intensive chemotherapy CSI 23.4/PF 55.8 VCR, CDDP, CPM with autologous SCR 4 cycles 5-yr PFS 83.2%
ACNS 0331 [38] 549 3–21 yr, M0, ≤1.5 cm2 Randomized trial, 1) evaluating PFRT vs. IFRT, 2) standard dose CSI (24 Gy) vs. low dose CSI (18 Gy) for young children (3–7 yrs) CSI 23.4 or 18/PF or IFRT 54 A: CDDP, CCNU, VCR
B: CPM,VCR (AABAABAAB)
5-yr EFS 81.4 (82.5% for IFRT, 80.5% for PFRT; 82.9% for SDCSI vs. 71.4% for LDCSI)

CSI, craniospinal irradiation; PF, posterior fossa; VCR, vincristine; CCNU, lomustine; CDDP, cisplatin; PFS, progression-free survival; RT, radiotherapy; CT, chemotherapy; VP, etoposide; CBP, carboplatin; CPM, cyclophosphamide; EFS, event free survival; TB, tumor bed; SCR, stem cell rescue; LC/A, large cell/anaplastic; HFRT, hyperfractionated radiation therapy; GTR, gross total resection; NTR, near total resection; PFRT, posterior fossa radiation therapy; IFRT, involved field radiation therapy; SDCSI, standard dose CSI; LDCSI, low dose CSI