30-MAY-2023 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 0 0 0 0 0 11/27/2017    
            240 0 0 0 0 0      
 
    2 N 1 Trastuzumab + Pertuzumab   26 0 0 0 0 0 11/27/2017    
        2 Cetuximab + Irinotecan   28 0 0 0 0 0      
            54 0 0 0 0 0      
 
    3 Y 3 Crossover: Trastuz + Pertuz   20 1 0 0 0 0 11/27/2017    
            20 1 0 0 0 0      
 
  S1922-Small Bowel,Ram+Pac vs FOLFIRI, mets/unresect 1 Y 1 Ramucirumab + Paclitaxel 94 15 3 0 0 0 0 06/01/2020 156 56
        2 FOLFIRI   12 3 1 1 0 0      
            27 6 1 1 0 0      
 
  S2001-Rando II, Mets Pancreas , BRCA1/2, Comb Chemo 1 Y 1 Olaparib + Pembrolizumab 88 18 11 7 3 1 0 02/22/2021 219 79
        2 Olaparib   15 7 5 2 0 0      
            33 18 12 5 1 0      
 
  S2104-Panc,Resect High-risk,Postop Adj Chemo vs Obs 1 Y 1 Capecitabine Temozolomide 154 11 11 7 5 2 0 05/05/2022 162 55
        2 Observation   7 6 1 0 0 0      
            18 17 8 5 2 0      
 
  S2107-Colorectal, BRAF mut, Enc + CET +/-Nivo 1 Y 1 Nivolumab + Encorafenib + Cetuximab 84 15 15 12 6 3 0 07/19/2022 179 65
        2 Encorafenib Cetuximab   11 11 8 4 0 0      
            26 26 20 10 3 0      
 
Yes A021806-Pancreas, Perioperative vs Adjuvant Chemo 0 E Total Registrations   25 8 4 2 0 0 10/08/2020 272 124
            25 8 4 2 0 0      
 
    1 E Total Registrations   20 5 2 2 0 0 10/08/2020    
            20 5 2 2 0 0      
 
  A022104-Rectal, Loc Adv, Triplet vs Doublet Chemo 1 E Total Registrations   3 3 3 3 1 0 03/13/2023 43 29
            3 3 3 3 1 0      
 
  EA2174-Esoph, Peri-Op Nivolumab +/- Ipilimumab 1 E Total Registrations   6 4 1 0 0 0 06/01/2021 218 96
            6 4 1 0 0 0      
 
    2 E Total Registrations   3 2 2 0 0 0 06/01/2021    
            3 2 2 0 0 0      
 
  EA2186-PANC, mets, Gem+Abraxane vs 5-FU+LV+Nal-IRI 1 E Total Registrations   23 8 4 3 3 1 11/18/2020 304 113
            23 8 4 3 3 1      
 
  EA2192-Panc, APOLLO 0 E Total Registrations   2 2 2 1 1 0 12/07/2022 136 69
            2 2 2 1 1 0      
 
  NRGGI008-Colon, Stg III, Adj Chemo 1 E Total Registrations   9 9 9 3 1 0 12/08/2022 164 45
            9 9 9 3 1 0      
 
    2 E Total Registrations   5 5 5 3 2 1 12/08/2022    
            5 5 5 3 2 1      
 
No A021602-PANC, Adv PNET Blinded Cabozantinib v Placebo 1 E Total Registrations   23 6 4 3 1 0 06/11/2019 216 93
            23 6 4 3 1 0      
 
    2 E Total Registrations   1 0 0 0 0 0 06/11/2019    
            1 0 0 0 0 0      
 
  A022102-Gastric, FOLFIRINOX +/-Nivo vs FOLFOX +/ Nivo 1 E Total Registrations   1 1 1 1 1 0 05/15/2023 2 2
            1 1 1 1 1 0      
 
  EA2176-Anal, Met, Immune Check Pt Inhibition + Chemo 1 E Total Registrations   18 6 4 2 1 0 08/09/2021 193 86
            18 6 4 2 1 0      
 
  EA2182-Anal, Erly, DECREASE 0 E Total Registrations   7 6 3 2 1 0 05/04/2022 271 91
            7 6 3 2 1 0      
 
    1 E Total Registrations   8 7 4 3 1 0 05/04/2022    
            8 7 4 3 1 0      
 
  EA2187-ICC, Carboplatin+Paclitaxel +/- Pevonedistat 1 E Total Registrations   7 0 0 0 0 0 12/09/2020 227 69
            7 0 0 0 0 0      
 
  EA2197-Gal, Rando Perioperative TX 1 E Total Registrations   3 2 1 1 1 0 11/18/2021 146 77
            3 2 1 1 1 0      
 
  NRGGI004-Colorectal, Stg IV, dMMR Immuno-Therapy 1 Y Total Registrations   15 0 0 0 0 0 04/18/2018 341 118
            15 0 0 0 0 0      
 
  NRGGI005-COLON,Stg IIA, ctDNA in Adjuvant Chemotherapy 1 Y Total Registrations   35 20 7 3 2 1 07/06/2020 424 158
            35 20 7 3 2 1      
 

30-MAY-2023 6:10

GI Open Studies with No Registrations

Study Registration/Phase Open Date # of
ACT.
INSTs
# of
CURR
IRBs
EA2192 Panc, APOLLO 1 Randomization 29-Apr-21 136 69
NRGGI008 Colon, Stg III, Adj Chemo 3 Randomization 10-Mar-22 164 45