Table 4.
Selected trials evaluating the role of heavy-particle therapy for pancreatic cancer.
| Study | Study design | N | Resectability status | Dose (GyE/RBE)/# | Type of particles | CT | Resection rate (%) | R0 resection rate (%) | LC (at 1 year, %) | Grade ⩾3 GI toxicity (%) |
Median survival from diagnosis (months) |
||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Acute | Late | All | Res | ||||||||||
| LAPC | |||||||||||||
| Terashima et al.167 | Phase I/II | 50 | LAPC | 50–70.2/25–26 | Protons | S/C: gem | / | / | 81.7 | 18 | 10 | NR | / |
| Sachsman et al.168 | Phase I/II | 11 | LAPC | 59.4/33 | Protons | I: Gem or FOLFIRINOX CRT: capecitabine |
27 | 33 | 86 | 0 | 0 | 18.4 | NR |
| Shinoto et al.169 | Phase I/II | 72 | LAPC | 43.2–55.2/12 (dose-escalation) | Carbon-ion | S: Gem (dose-escalation) | / | / | 92 | 7 | 1 | 19.6 | / |
| Jethwa et al.170 | Retrospective | 13 | LAPC | 50/25 | Protons (IPMT) | I: FOLFIRINOX or gem/nab-paclitaxel S: 5-FU or capecitabine |
/ | / | 66 | 0 | 0 | NR At 1 year: 62% |
/ |
| Kawashiro et al.171 | Retrospective | 72 | LAPC | 52.8–55.2/12 | Carbon-ion | I (74%): gem-based or FOLFIRINOX S (78%): gem and/or S-1 |
/ | / | 84 | 3 | 1 | 21.5 | / |
| Shinoto et al.172 | Retrospective | 64 | LAPC | 55.2/12 | Carbon-ion | I (76%): gem-based or FOLFIRINOX S: gem and/or S-1 |
/ | / | 75 | 6 | 0 | 25.1 | / |
| Potentially resectable | |||||||||||||
| Shinoto et al.173 | Phase I | 26 | R | 30–36.8/8 | Carbon-ion | / | 81 | 90.5 | 100 (resected only) | 0 | 0 | 18.6 | Not reached |
| Hong et al.174 | Phase I/II | 48 | R | 25/5 | Protons | S: capecitabine | 77 | 84 | NR | 4 | NR | 17.3 | 27 |
#, number of fractions; C, consolidation; CRT, chemoradiotherapy; FOLFIRINOX, oxaliplatin, irinotecan, leucovorin and fluorouracil; Gem, gemcitabine; GI, gastrointestinal; GTX, gemcitabine/docetaxel/capecitabine; GyE, Gray equivalent; I, induction; IPMT, intensity proton modulated therapy; LAPC, locally advanced pancreatic cancer; LC, local control; N, number of patients; NR, not reported; R, resectable; RBE, radiobiological equivalent; S, sensitizer; S-1, combination Tegafur/gimeracil/oteracil.