05-JUL-2022 6:10

GI ACCRUAL REPORT - Open and Recently Closed Studies

SWOG/
Support		 STUDY R
E
G		 O
P
E
N		 ARM ACCR.
GOAL		 TOTAL
REGS.		 REGS.
LAST
12
Month		 REGS.
LAST
6
Month		 REGS.
LAST
3
Month		 REGS.
LAST
30
DAYS		 REGS.
LAST
7
DAYS		 DATE OF
FIRST
REG.		 # of
ACT.
INSTs		 # of
CURR
IRBs
SWOG S1613-mCRC, Adv/Met, TP vs CETIRI 1 N 0 Screening 130 240 16 0 0 0 0 11/27/2017 312 105
            240 16 0 0 0 0      
 
    2 N 1 Trastuzumab + Pertuzumab   26 3 1 0 0 0 11/27/2017    
        2 Cetuximab + Irinotecan   28 2 0 0 0 0      
            54 5 1 0 0 0      
 
    3 Y 3 Crossover: Trastuz + Pertuz   20 7 2 2 1 0 11/27/2017    
            20 7 2 2 1 0      
 
  S1922-Small Bowel,Ram+Pac vs FOLFIRI, mets/unresect 1 Y 1 Ramucirumab + Paclitaxel 94 12 4 2 1 0 0 06/01/2020 155 57
        2 FOLFIRI   9 2 0 0 0 0      
            21 6 2 1 0 0      
 
  S2001-Rando II, Mets Pancreas , BRCA1/2, Comb Chemo 1 Y 1 Olaparib + Pembrolizumab 88 7 6 5 2 0 0 02/22/2021 195 77
        2 Olaparib   8 7 5 3 0 0      
            15 13 10 5 0 0      
 
  S2104-Panc,Resect High-risk,Postop Adj Chemo vs Obs 1 Y 1 Capecitabine Temozolomide 154 2 2 2 2 2 1 05/05/2022 112 36
        2 Observation   2 2 2 2 1 0      
            4 4 4 4 3 1      
 
Yes A021502-Colon, Stg III, Chemo +/- Atezol, ATOMIC 1 E Total Registrations   59 11 3 3 0 0 03/23/2018 400 177
            59 11 3 3 0 0      
 
  A021806-Pancreas, Perioperative vs Adjuvant Chemo 0 E Total Registrations   19 13 5 2 2 1 10/08/2020 257 119
            19 13 5 2 2 1      
 
    1 E Total Registrations   16 11 3 1 1 0 10/08/2020    
            16 11 3 1 1 0      
 
  EA2174-Esoph, Peri-Op Nivolumab +/- Ipilimumab 1 E Total Registrations   2 1 1 1 0 0 06/01/2021 225 84
            2 1 1 1 0 0      
 
    2 E Total Registrations   1 1 0 0 0 0 06/01/2021    
            1 1 0 0 0 0      
 
  EA2186-PANC, mets, Gem+Abraxane vs 5-FU+LV+Nal-IRI 1 E Total Registrations   16 8 2 2 1 0 11/18/2020 278 108
            16 8 2 2 1 0      
 
No A021602-PANC, Adv PNET Blinded Cabozantinib v Placebo 1 E Total Registrations   17 5 1 0 0 0 06/11/2019 237 92
            17 5 1 0 0 0      
 
    2 E Total Registrations   1 1 0 0 0 0 06/11/2019    
            1 1 0 0 0 0      
 
  A021703-COLON, Adv/Met, Chemo + Std v High dose V-D3 1 E Total Registrations   24 12 5 4 0 0 03/04/2020 336 155
            24 12 5 4 0 0      
 
  EA2176-Anal, Met, Immune Check Pt Inhibition + Chemo 1 E Total Registrations   12 12 7 3 0 0 08/09/2021 185 82
            12 12 7 3 0 0      
 
  EA2182-Anal, Erly, DECREASE 0 E Total Registrations   2 2 2 2 1 1 05/04/2022    
            2 2 2 2 1 1      
 
    1 E Total Registrations   2 2 2 2 1 1 05/04/2022    
            2 2 2 2 1 1      
 
  EA2187-ICC, Carboplatin+Paclitaxel +/- Pevonedistat 1 E Total Registrations   7 0 0 0 0 0 12/09/2020 193 69
            7 0 0 0 0 0      
 
  EA2197-Gal, Rando Perioperative TX 1 E Total Registrations   2 2 1 1 1 1 11/18/2021 122 66
            2 2 1 1 1 1      
 
  NRGGI004-Colorectal, Stg IV, dMMR Immuno-Therapy 1 Y Total Registrations   15 1 0 0 0 0 04/18/2018 291 120
            15 1 0 0 0 0      
 
  NRGGI005-COLON,Stg IIA, ctDNA in Adjuvant Chemotherapy 1 Y Total Registrations   20 16 7 6 4 0 07/06/2020 410 163
            20 16 7 6 4 0      
 

05-JUL-2022 6:10

GI Open Studies with No Registrations

Study Registration/Phase Open Date # of
ACT.
INSTs		 # of
CURR
IRBs
S2107 Colorectal, BRAF mut, Enc + CET +/-Nivo 1 Initial Registration 06-Jun-22 23 8