JROSG10-2

1 Japanese Radiation Oncology Study Group ( ) (A) JROSG10-2 5FU+MMC II A phase II study of concurrent chemoradiotherapy with 5-fluorouracil and mitomycin-C for squamous cell carcinoma of the anal canal 113-8677 3-18-22 Tel: 03-3823-2101 (65021) Fax: 03-4463-7543 E-mail: 113-8677 3-18-22 Tel: 03-3823-2101 (65021) Fax: 03-4463-7543 E-mail: 2010 7 24 2013 7 27 2016 2 6 2018 1 23 1 0.

2 I-III 5-FU Mitomycin C(MMC) 1) primary endpoint 2 2) secondary endpoint 1) 2) TNM (UICC 7 2009 ) T1-4N0-3M0 3) ECOG PS0-1 T1-4 N0-3 M0 20 80 PS 0-1 5FU+MMC 2 4) 20 75 76 80 5) 6) 7) 8) 9) 6MV X 1 1 5 IMRT SIB 5-FU 800mg/m2/day 1-4 29-32 96 MMC 10mg/m2( 20mg/body) 1 29 40 6 2 8 113-8677 3-18-22 Tel: 03-3823-2101 (65021) Fax: 03-4463-7543 E-mail: 113-8677 3-18-22 03-3823-2101 Fax 03-4463-7543 E-mail.

3 3 0.. 1 1.. 7 2.. 7 3.. 7 .. 7 .. 7 .. 8 .. 8 .. 10 .. 10 .. 10 .. 10 .. 10 .. 11 .. 11 .. 11 .. 11 4.. 11 ( 7 ) .. 11 .. 12 TNM .. 12 (TNM-UICC 7 2009 ) .. 13 ( 7 ) .. 13 5.. 14 5. 1.. 14 ( ) .. 14 6.. 16 .. 16 .. 16 7.. 16 .. 16 .. 17 .. 18.

4 23 .. 23 .. 23 .. 23 2 .. 24 4 .. 25 .. 26 .. 26 .. 26 .. 29 .. 29 8.. 30 .. 30 RTOG-9811 MMC-5-FU-RT .. 31 .. 32 9.. 32 .. 32 .. 32 2 .. 33 .. 33 .. 33 .. 33 / .. 34 / .. 34 / .. 34 .. 36 10.. 37 (Case Report Form).

5 37 .. 37 .. 37 .. 38 .. 38 .. 38 11.. 39 .. 39 (AE Adverse Event) .. 39 . (ADR Adverse Drug Reaction) .. 39 . (AR Adverse Reaction) .. 39 .. 39 .. 39 .. 39 .. 40 .. 40 .. 40 / .. 40 5 .. 40 .. 40 .. 41 .. 41 .. 41 12.. 42 .. 42 .. 42.

6 42 .. 42 .. 42 .. 42 ( ) .. 43 .. 43 .. 43 .. 43 .. 43 .. 43 .. 44 .. 44 .. 44 .. 44 .. 44 .. 44 ( ) .. 44 .. 45 13.. 46 .. 46 .. 46 .. 46 .. 46 14 .. 46 .. 46 .. 47 .. 47 .. 48 .. 48 .. 48 IRB .. 48 .. 48 6 IRB.

7 49 .. 49 .. 49 / IRB .. 49 .. 50 15.. 50 .. 50 .. 50 .. 50 .. 50 .. 51 .. 51 16.. 51 .. 51 17.. 52 JROSG (Japanese Radiation Oncology Study Group .. 52 JROSG .. 52 .. 52 .. 52 .. 52 .. 53 JROSG .. 53 .. 53 JROSG .. 53 .. 54 18.. 54 19.. 55 20. APPENDIX .. 56 7 1. I-III 5-FU Mitomycin C(MMC) 2.)

8 1)primary endpoint 2 2)secondary endpoint 3. 4 (1) 30 3 human papillomavirus(HPV) HIV 2012 6230 780 (1) 2003 261 2003 73 1,540 226( ) (2) 40 ( ) ( ) ( ) 8 2003 2 9 (2) TNM HIV Stage I-III (3)

9 80% Nigro (4) (5-7) 65-75 15 8 5-FU+MMC (3) 5 40-60% QOL (8) (Abdominoperineal resection; APR) (9) ( ) 1995 10 ( ) 64 5 78 5 73 5 58 (10) JCOG Stage II/III 25 CR 80 3 77 (11)

10 II Japan Clinical Oncology Group (JCOG) S 1 MMC RT( ) I/II (12) 5-FU MMC RT( ) JCOG IMRT NCCN IMRT 1) MDAH RT 5-FU 45-49Gy 4/13 (31%) 50-55Gy 5/7 (71%) 55Gy< 14/16(87%) (13) MDACC 5-FU+CDDP RT(55Gy) 45/62(73%) 53/62(85%) Kansas <45Gy 64% 45-55Gy 72% >55Gy 92%(p= ) (14) >55Gy MGH (>54Gy vs.