Histologically confirmed locally advanced gastric (primary endpoint includes proximal and mid-body stomach) or esophagogastric adenocarcinoma; distal gastric (antral) adenocarcinomas are eligible for enrolment but will not be included in the primary analysis
Locally advanced disease as determined by endoscopic ultrasound (EUS) stage > primary tumor (T) 3 and/or any T, lymph nodes (N)+ disease without metastatic disease (Mx)
All patients must have diagnostic laparoscopy with diagnostic washings for cytology; both cytology positive and negative patients are eligible for enrolment, but only cytology negative patients will be included in the primary analyses; gross peritoneal disease is not eligible
Eastern Cooperative Oncology Group (ECOG) performance status =< 1
Eligible for surgery with curative intent
Absolute neutrophil count (ANC) >= 1250/ul
Hemoglobin >= 9 g/dL
Platelets >= 100,000/ul
Total bilirubin < 1.5 x upper limit of normal
Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) < 2.5 x upper limit of normal for patients without liver metastases OR SGOT and SGPT < 5 x upper limit of normal for patients with liver metastases
Creatinine =< 1.5 x upper limit of normal
Measurable or non-measurable disease by Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 will be allowed
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation, up until 30 days after final study treatment; should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately
Patients taking substrates, inhibitors, or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) should be encouraged to switch to alternative drugs whenever possible, given the potential for drug-drug interactions with irinotecan
Signed informed consent

NCT02366819_inc_T1
Condition
esophagogastric adenocarcinoma
NCT02366819_inc_T2
Condition
adenocarcinoma gastric
NCT02366819_inc_T3
Qualifier
locally advanced
NCT02366819_inc_T4
Scope
gastric (primary endpoint includes proximal and mid-body stomach) or esophagogastric adenocarcinoma
NCT02366819_inc_T5
Qualifier
mid-body stomach
NCT02366819_inc_T6
Qualifier
proximal stomach
NCT02366819_inc_T7
Scope
proximal and mid-body stomach
NCT02366819_inc_T8
Condition
adenocarcinomas
NCT02366819_inc_T9
Qualifier
distal gastric
NCT02366819_inc_T10
Qualifier
antral
NCT02366819_inc_T12
Condition
disease
NCT02366819_inc_T13
Qualifier
Locally advanced
NCT02366819_inc_T14
Procedure
endoscopic ultrasound
NCT02366819_inc_T15
Value
> primary tumor (T) 3 and/or any T, lymph nodes (N)+ disease without metastatic disease (Mx)
NCT02366819_inc_T16
Procedure
EUS
NCT02366819_inc_T17
Procedure
laparoscopy
NCT02366819_inc_T18
Qualifier
diagnostic
NCT02366819_inc_T19
Procedure
washings for cytology
NCT02366819_inc_T20
Measurement
cytology
NCT02366819_inc_T21
Value
positive
NCT02366819_inc_T22
Value
negative
NCT02366819_inc_T23
Scope
positive and negative
NCT02366819_inc_T25
Measurement
tern Cooperative Oncology Group (E formance status =<
NCT02366819_inc_T26
Value
=< 1
NCT02366819_inc_T27
Measurement
ECOG
NCT02366819_inc_T28
Procedure
surgery
NCT02366819_inc_T29
Qualifier
curative
NCT02366819_inc_T30
Measurement
Absolute neutrophil count
NCT02366819_inc_T31
Measurement
ANC
NCT02366819_inc_T32
Value
>= 1250/ul
NCT02366819_inc_T33
Measurement
Hemoglobin
NCT02366819_inc_T34
Value
>= 9 g/dL
NCT02366819_inc_T35
Measurement
Platelets
NCT02366819_inc_T36
Value
>= 100,000/ul
NCT02366819_inc_T37
Measurement
Total bilirubin
NCT02366819_inc_T38
Value
< 1.5 x upper limit of normal
NCT02366819_inc_T39
Measurement
Serum glutamic oxaloacetic transaminase
NCT02366819_inc_T40
Measurement
SGOT
NCT02366819_inc_T41
Measurement
serum glutamate pyruvate transaminase
NCT02366819_inc_T42
Measurement
SGPT
NCT02366819_inc_T43
Value
< 2.5 x upper limit of normal
NCT02366819_inc_T44
Negation
without
NCT02366819_inc_T45
Condition
liver metastases
NCT02366819_inc_T46
Measurement
SGOT
NCT02366819_inc_T47
Measurement
SGPT
NCT02366819_inc_T48
Value
< 5 x upper limit of normal
NCT02366819_inc_T49
Condition
liver metastases
NCT02366819_inc_T50
Scope
Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT)
NCT02366819_inc_T51
Scope
SGOT and SGPT
NCT02366819_inc_T52
Measurement
Creatinine
NCT02366819_inc_T53
Value
=< 1.5 x upper limit of normal
NCT02366819_inc_T54
Measurement
Response Evaluation Criteria in Solid Tumor
NCT02366819_inc_T55
Measurement
RECIST
NCT02366819_inc_T56
Value
1.1