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. 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)

2 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 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 .. 23 .. 23.

3 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) .. 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 /.

4 40 5 .. 40 .. 40 .. 41 .. 41 .. 41 12.. 42 .. 42 .. 42 .. 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 .. 49 .. 49 .. 49 / IRB .. 49 .. 50 15.. 50 .. 50 .. 50.

5 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. 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)

6 TNM HIV Stage I-III (3) 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) II Japan Clinical Oncology Group (JCOG) S 1 MMC RT( ) I/II (12) 5-FU MMC RT( ) JCOG IMRT NCCN IMRT 1)

7 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. <54Gy; 77% vs. 61% p= 84% vs. 47% p= )(15) 55Gy 9 60Gy 60Gy 2) CTV CTV MDACC 1 (16) CTV AGITG (17) CTV appendix 3) (Intensity Modulated Radiation Therapy IMRT) IMRT CT ( )

8 IMRT IMRT IMRT IMRT IMRT IMRT (18) (PTV) 1 IMRT PTV 95% (D95) 4 PTV SIB RTOG05-29 IMRT two-step Gy/33 2013 1,093,300 ( ) 4 Gy/33 677,300 40 10 5FU Mitomycin C (9) 5-FU 1000mg 800mg I-III 5FU Mitomycin C(MMC) 5FU+MMC 5FU+CDDP III RTOG98-11 primary endpoint 5 5FU+MMC 5-FU MMC (19 20) UKCCCR ACT-II CDDP MMC (21) 5-FU MMC (18)

9 IMRT IMRT RTOG 98-11 2 70 2 70% 95 15% 36 40 JROSG 1995 2000 6 64 10 2000 6 10 JCOG 10 40 3 2013 11 6 8. IMRT 5. Japan Clinical Oncology Group (JCOG) S 1 MMC RT( ) I/II 5-FU MMC RT( ) JCOG IMRT NCCN IMRT 2 4.

10 TNM-UICC 7 2009 7 ( 7 ) 12 TNM T- (TNM-UICC 7 2009 ) TX Tis T0 T1 2cm T2 2cm 5cm T3 5cm T4 N- (TNM-UICC 7 ) NX N0 N1 N2 N3 1 M- (TNM-UICC 7 2009 ) MX M0 M1 13 (TNM-UICC 7 2009 ) (TNM ) ( 7 ) 1. 2. Adenocarcinoma Rectal Type Anal gland origin Associated with anal Fistula Squamous cell carcinoma (scc) Adenosquamous carcinoma (asc) Basaloid carcinoma Miscellaneous carcinoma 2 Paget Extramammary Paget disease 3 Malignant melanoma 4 5 Fibrovascular polyp( fibrous polyp) 7 14 5.