A Phase II study of laparoscopic gastrectomy for advanced gastric cancer with neoadjuvant chemotherapy

A Phase II study of laparoscopic gastrectomy for advanced gastric cancer with neoadjuvant chemotherapy - A Phase II study of laparoscopic gastrectomy for advanced gastric cancer with neoadjuvant chemotherapy

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000031477

Enrollment

Registered

2018-04-27

Start date

2018-04-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced gastric cancer with with neoadjuvant chemotherapy

Interventions

Laparoscopic gastrectomy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Histologically proven gastric carcinoma (including esophago-gastric junctional cancer) (2)Prior treatment of chemotherapy for gastric cancer (3)R0 resection or R1 resection solely by CY1 can be obtained (4)Aged 20 to 79 years (5) Eastern Cooperative Oncology Group (ECOG) PS of 0-2 (6) No obvious organ failures and satisfy the following laboratory data within 30 days before registration: WBC >=2,000/mm3 WBC<15,000/mm3 Platelet >= 50,000/mm3 Hb >= 8.0 g/dL AST <= local reference range 5 ALT <= local reference range 5 T.Bil <= 3.0 mg/dL Creatinin <= 2.0 mg/dL (7)Provided written informed consent

Exclusion criteria

Exclusion criteria: (1)Active infection disease (2)Over 38.0 degree Celsius (3)Severe mental disease. (4)Continuous systemic steroid therapy. (5)History of myocardial infarction or unstable angina pectoris within six months. (6)Uncontrollable hypertension. (7)Uncontrollable diabetes millutus or administration of insulin. (8)Severe respiratory disease requiring continuous oxygen therapy. (9)Kidney failure requiring hemodialysis or peritoneal dialysis (10)Patients who are currently participating in an interventional study that strongly influences this study. (11)Other unfeasible factors to perform study safely approved by attending surgeon.

Design outcomes

Primary

Measure	Time frame
Grade 3 or higher surgical complications (Clavien-Dindo Classification)	—

Secondary

Measure	Time frame
All surgical complications (Clavien-Dindo Classification), recurrence-free survival,over all survival, proportion of conversion to open surgery,number of retrieved lymph node, postoperative hospital stay, completion rate of adjuvant chemotherapy,	—

Countries

Japan

Contacts

Public ContactAtsushi Gakuhara

Osaka University School of Medicine Gastroenterological Surgery

agakuhara@gesurg.med.osaka-u.ac.jp06-6879-3251

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026