Table 1.
Basic characteristics of included studies.
| Trial | Study ID | Country | Study design | Intervention | Tumor stage | Duration | Sample Size | Mean/Median Age (year) | Radiotherapy details | median follow-up (months) | Outcomes | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Total dose (GyE) | Fraction | Duration (week) | |||||||||||
| Protocol9402 | Shimazaki, 2010 (32) | Japan | Retrospective phase I/II trial | CIRT | T2b-T3N0M0 | 1995-2000 | 35 | 69 | 54-72 | 20 | 5 | 47 | OS,BRF,LCR,GI,GU |
| Protocol9703 | Shimazaki, 2010 (32) | Japan | retrospective phase I/II trial | CIRT | T1b-T2N0M0 | 1995-2000 | 61 | 69 | 60-66 | 20 | 5 | 84 | OS,BRF,LCR,GI,GU |
| Protocol9904(a) | Shimazaki, 2010 (32) | Japan | retrospective phase I/II trial | CIRT | T1b-T2a | 2000-2003 | 175 | 70 | 60-66 | 20 | 5 | 43 | OS,BRF,LCR,GI,GU |
| NR | Nikoghosyan, 2011 (33) | Germany | prospective phase I/II trial | CIRT + IMRT | T1-3 | 2006-2008 | 14 | 68 | 60 | 20 | 5 | 28 | GI,GU |
| Protocol9904(b) | Hitoshi, 2012 (34) | Japan | retrospective phase II trial | CIRT | T1b-T3bN0M0 | 2003-2005 | 120 | 67.6 | 66 | 20 | 5 | 21 | OS,BRF,LCR |
| Protocol9904-2 | Hitoshi, 2012 (34) | Japan | retrospective phase II trial | CIRT | T1b-T3bN0M0 | 2005-2007 | 171 | 67.6 | 63 | 20 | 5 | 29 | OS,BRF,LCR |
| Protocol9904-3 | Hitoshi, 2012 (34) | Japan | retrospective phase II trial | CIRT | T1b-T3bN0M0 | 2007- | 520 | 67.6 | 57.6 | 20 | 5 | 43 | OS,BRF,LCR |
| Protocol9904 | Okada, 2012 (35) | Japan | retrospective phase II trial | CIRT | T1b-T3 | 2000-2009 | 664 | 68.2 | 63-66 | 20 | 5 | 24 | OS,BRF,GI,GU |
| Protocol9904 | Katoh, 2014 (36) | Japan | prospective study | CIRT | T1c-T3bN0M0 | 2000-2004 | 213 | 69.4 | 66 | 20 | 5 | 36 | OS,BRF,GI,GU |
| Protocol1002 | Nomiya, 2014 (37) | Japan | prospective phase I/II trial | CIRT | T1b-T3bN0M0 | 2010- | 46 | 66 | 51.6 | 12 | 3 | 32.3 | OS,GI,GU |
| ProtocolGUNMA0702 Protocol/ GUNMA0702EX | Hitoshi, 2015 (38) | Japan | prospective phase II trial | CIRT | T1c-T4 | 2010-2011 | 76 | 66 | 57.6 | 16 | 5 | 51 | OS,BRF,GI,GU |
| NR | Habl, 2016 (17) | Germany | RCT | PBT vs CIRT | T1c-T3bN0M0 | 2012-2013 | 46 | 68 | 66 | 20 | 3.5 | 22.3 | GI,GU,QOL |
| J-CROS 1501PR | Nomiya, 2016 (12) | Japan | prospective phase II trial | CIRT | T1c-T3bN0M0 | 2003-2014 | 2157 | 67 | 51.6-66 | 20 | 5 | 43 | OS,BRF,LCR,GI,GU |
| Protocol9904 | Maruyama, 2017 (19) | Japan | prospective phase II trial | CIRT | T1-3 | 2000-2007 | 417 | 69 | 63-66 | 20 | 5 | 60 | QOL |
| NR | Zhang, 2019 (2) | China | retrospective observational study | C-RT | T1-T4 | 2015-2018 | 64 | 70.5 | 59.2-66 | 24 | 5 | 24 | GI,GU |
| GUNMA0702 | Kawamura, 2020 (40) | Japan | prospective observational study | CIRT | T1–T3N0M0 | 2010-2013 | 304 | 66 | 57.6 | 16 | 4 | 60 | BRF,LCR,OS,GI,GU |
| NR | Takakusagi, 2020 (16) | Japan | retrospective observational study | CIRT | T1bN0M0-T3bN0M0 | 2015- 2017 | 253 | 70 | 51.6 | 12 | 3 | 51.6 | BRF,GI,GU |
| NR | Nihei, 2011 (53) | Japan | Prospective phaseI/II | PBT | T1c- T3a | 2004-2007 | 151 | 67 | 74 | 37 | NR | 43.4 | GI,GU |
| NR | Yu,2012 (57) | USA | Retrospective observational study | PBT VS IMRT | NR | 2008-2009 | 27647 | 66-94 | NR | NR | NR | 12 | GI,GU |
| protocols PR-01 (UFJ-2005154); PR-02 (UFJ-2006-63); PR-03 (UFJ-2006-94) | Mendenhall, 2013 (50) | USA | Prospective observational study | PBT | NR | 2006-2007 | 211 | 68 | 78-82 | 39 | NR | 62.4 | OS,GI,GU |
| protocol PR-01/02 | Henderson, 2013 (45) | USA | Prospective observational study | PBT | NR | 2006-2007 | 171 | 66 | 74 | 39 | NR | 43.4 | GU |
| NR | Kim, 2013 (48) | Korea | Prospective phaseII | PBT | T1-T3N0M0 | NR | 82 | 68 | 35-60 | 5-20 | 5 | 42 | GI,GU |
| NR | Fang, 2014 (43) | USA | Case-Matched Study | PBT vs IMRT | NR | PBT:2010-2012 IMRT:2009-2012 | 394 | ³40 | 79.2 | 44 | NR | 47 | GI,GU |
| protocol (OTP) | Bryant, 2016 (41) | USA | Prospective observational study | PBT | T1-T3 | 2006-2010 | 1327 | 66 | ³75 | 26 | NR | 63.6 | OS,GI,GU |
| NR | Vargas, 2016 (56) | USA | Prospective observational study | PBT | T1- T2 | NR | 49 | 65 | 38 | 5 | NR | 18 | GI,GU |
| protocol, PR04 | Henderson, 2017 (44) | USA | Prospective observational study | PBT | T1–T2b | 2008-2011 | 215 | 65 | 70-72.5 | 28-29 | 9.5 | 62.4 | OS,GI,GU |
| NR | Iwata, 2017 (47) | Japan | Retrospective observational study | PBT | T1-T4 | 2008-2011 | 1291 | 68 | 70-80; 63-66 | 35-40;21-22 | NR | 69 | OS, BRF,GI,GU |
| NR | Nakajima, 2018 (52) | Japan | Prospective phaseI/II | HFPT vs CFPT | T1–T3N0M0 | 2013-2016 | 526 | 69.5 | 63-78 | CFPT20-37 HFPT:21-39 | CFPT:7.8;HFPT:4.2 | ³6 | GI,GU |
| NR | Arimura, 2018 (18) | Japan | Prospective observational study | PBT | T2a-T3b | 2011-2014 | 204 | 65 | 70;74;78 | 28;37;39 | NR | 52 | OS,GI,GU |
| Medicare claims | Pan, 2018 (54) | USA | Retrospective observational study | PBT vs SBRT vs IMRT | NR | 2008-2015 | 12128 | ≤65 | NR | IMRT: 42; proton radiation: 39 ; SBRT:5 | NR | 23 | GI,GU |
| NR | Ho, 2018 (46) | USA | Prospective observational study | PBT | T1c -T3a | 2006-2010 | 254 | 56 | 70-82 | 2-2.5 Gy/fraction | NR | 85.2 | OS |
| NR | Chuong, 2018 (42) | USA | Prospective observational study | PBT | T1-T3 | 2010-2016 | 85 | 69 | 70–80.2 | 44 | NR | 14.5 | GI,GU |
| NR | Santos, 2019 (55) | USA | Retrospective observational study | PBT VS IMRT | NR | 2009-2017 | 307 | 59.7 | 66.0-70.2 | 1.8-2.0-Gy/fraction | NR | 46.1 | GU,GI |
| NR | Slater, 2019 (13) | USA | Prospective phaseI/II | PBT | T1-T2a | 2009-2017 | 167 | 65 | 60 | 20 | 4 | 42 | GU,GI |
| PCG 001-09 | Mishra, 2019 (51) | USA | Prospective observational study | PBT | T1-T2c | 2009-2017 | 1343 | 66.6;65.2 | 79.3; 79.4 | NR | NR | 16.5; 27.2 | GI, GU, |
| NR | Lee, 2019 (49) | USA | Retrospective observational study | PBT | T1-T4 | 2013-2016 | 192 | 68 | 79.2 | 44 | NR | 20 | GI |
| NR | Takagi, 2020 (14) | Japan | Retrospective observational study | PBT | NR | 2003-2014 | 2021 | 68 | 74 | 37 | NR | 84 | BRF, OS, GI, GU |
CIRT, carbon ion radiotherapy; PBT, proton beam therapy; OS, Overall survival; LCR, Local control rate; GI, Gastrointestinal toxicity; GU, Urinary tract toxicity; QOL, Quality of life; IMRT, intensity modulated radiation therapy; HFPT, Hypofractionated proton therapy; CFPT, conventional fractionated proton therapy; SBRT, stereotactic body radiotherapy.
NR, not reported.