OGSG1402

JRCT ID: jRCTs051180195

Registered date:26/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Gastric Cancer
• Date of first enrollment: 16/03/2015
• Target sample size: 48
• Study type: Interventional

Intervention(s)

2 or 3 courses of neoadjuvant chemotherapy (NAC)
(Docetaxel : 40mg/m2, iv day 1, CDDP : 60mg/m2, iv day 1, S-1 : 80 - 120 mg/body, day 1 - 14, every 4 weeks) followed by surgery within 42 days after NAC.
Postoperative 1-year, S-1 therapy in case of R0 resection.

Outcome(s)

• Primary Outcome: R0 resection rate
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: FUJITANI Kazumasa
• Secondary ID(s): UMIN000015631