Phase II study of S-1 and oxaliplatin as neoadjuvant chemotherapy for locally advanced adenocarcinoma of the gastric or esophagogastric junction(KSCC1601)

Phase 2

• Conditions: Gastric cancer/Esophagogastric junction cancer

• Registration Number: JPRN-jRCTs071180064
• Lead Sponsor: Oki Eiji

Brief Summary

Between 2016 April and 2017 July, 47 patients (24 EGC, 23 LAGC) were enrolled in this study. 42 patients (89.4%: 95%CI 76.9-96.5%) underwent surgery, and curative resection was performed in 41 patients. pRR, the primary endpoint (grade 1b to 3), was 25 cases (59.5%: 90%CI 45.7-72.3%) of primary lesions.The S-1 and oxaliplatin was well tolerated and is promising as a preoperative chemotherapy regimen for patients with LAGC and EGC.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-20
• Study Completion: 2020-06-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

1) The individual consents in writing to receipt of the protocol treatment
2) A lead investigator deems that the patient can be treated with the protocol (the patient is suitable for enrollment)
3) A common type of gastric adenocarcinoma (include Siewert Type III): T 3/4a/4b, N 1/2/3a/3b, esophagogastric junction adenocarcinoma classified as Siewert Type II: T 3/4a/4b, N 0/1/2/3a/3b
4) Enhanced thoracic/ abdominal/ pelvic CT revealed having none of the followings:
i) Lung metastasis
ii) Peritoneal metastasis
iii) Liver metastasis
iv) Pleural effusion, ascites
v) Distal lymph nodes metastasis
vi) Other distant metastasis
5) Clinically no sign of cervical lymph node nor distant metastasis
6) No liver metastasis and peritoneal metastasis, CY0 by laparoscopy
7) Not a remnant gastric cancer
8) No prior treatment of chemotherapy or radiation therapy or endocrine therapy against any other malignancies
9) No prior surgery for esophagogastric junction cancer and gastric cancer except for endoscopic resection
10) Age upon enrollment is over 20 years
11) Performance Status (ECOG) 0 or 1
12) The patient is readily able to take medication orally
13) The patient has no severe dysfunction of major organs (bone marrow, liver, kidneys, heart, lungs, etc.) and the patient's laboratory results from up to 14 days prior to enrollment fall within the criteria
i) WBC <=12,000/mm3
ii) Neutrophil >=1,500/mm3
iii) Platelet >=100,000/mm3
iv) Hemoglobin >=8.0g/dL
v) Total bilirubin <=1.5mg/dL
vi) AST,ALT <=100IU/L
vii) Albumin >=2.5g/dL
viii) Serum creatinine <=1.5mg/dL
ix) Creatinine clearance >=60mL/min

Exclusion Criteria

1) Severe drug hypersensitivity (particularly to platinum analogs, 5-FU, or S-1)
2) Peripheral neuropathy affecting the sensory nerves (Grade 1 or worse)
3) Active infection
4) Uncontrollable hypertension
5) Uncontrollable diabetes mellitus or routine administration of insulin
6) Heart disease that may pose a problem
7) Severe pulmonary disease
8) Severe mental disease
9) Active gastrointestinal tract bleeding requiring repeated transfusions
10) Under treatment with phenytoin, warfarin or flucytosine
11) Watery diarrhea (Grade 2 or worse)
12) Synchronous or metachronous malignancies other than carcinoma in situ or mucosal cancer
13) A woman who is pregnant, nursing, or possibly pregnant or a man who is trying to conceive with a partner
14) Cirrhosis or hepatitis
15) Patients judged by the investigator as unfit to be enrolled in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pathological response rate: pRR

Secondary Outcome Measures

Name	Time	Method
Anastomotic leakage of tumours are classified as Siewert Type II and Type III <br>Overall survival <br>Complete resection rate, resection rate <br>Relapse free survival <br>Response rate <br>Adverse events <br>Surgical complecations