OGSG1402

Phase 2

• Conditions: Gastric Cancer

• Registration Number: JPRN-jRCTs051180195
• Lead Sponsor: FUJITANI Kazumasa

Brief Summary

eoadjuvant therapy of TS-1+CCP+DTX against large Type 3 or Type 4 gastric cancer did not show good efficacy with R0 resection rate statistical significance at 0.391 which did not reach the commonly accepted cutoff of 0.05.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-26
• Study Completion: 2021-11-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1. Histologically proven adenocarcinoma of the stomach
2. Borrmann type 4 or large (larger than or equal to 8cm) type 3
3. No evidence of distant peritoneal metastasis,
No evidence of distant metastasis including liver or
para-aortic lymph node metastasis
4. No involvement of the esophagus with >3cm
5. Age of 20 - 75 years
6. Performance Status (ECOG) of 0 or 1
7. No prior chemotherapy or radiotherapy for any malignancy
No prior surgery for gastric cancer
8. Adequate organ function :
1) WBC : 4,000 /mm3 - 12,000 /mm3,
2) Neutrophil : more than or equal to 2,000 /mm3,
3) Platelet : more than or equal to 100,000 /mm3,
4) Hb : more than or equal to 8.0 g/dL,
5) AST(GOT), ALT(GPT) : less than or equal to 100 IU/L,
6) Total bilirubin : less than or equal to 1.5 mg/dL,
7) Ccr : more than or equal to 60 mL/min
9. Sufficient oral intake
10. Written informed consent

Exclusion Criteria

1. Synchronous or metachronous malignancies
2. Severe drug hypersensitivity
3. Infection or suspected infection with fever
4. Pregnancy or lactation
5. Cardiac infarction within 6 months
6. Continuous administration of steroids
7. Continuous administration of Frucitocin or Phenytoin
8. Uncontrollable diarrhea
9. HBs Ag positive or HCV Ab positive
10. Any severe complications

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
R0 resection rate

Secondary Outcome Measures

Name	Time	Method
Completion rate of neoadjuvant chemotherapy, Completion rate of adjuvant S-1, Progression-free survival, Overall survival, Response rate of neoadjuvant chemotherapy, Pathological response rate of neoadjuvant chemotherapy, Adverse events of neoadjuvant chemotherapy, Postoperative complications