Randomized phase II/III trial of steroid administration before gastric cancer surgery

Randomized phase II/III trial of steroid administration before gastric cancer surgery - Randomized phase II/III trial of steroid administration before gastric cancer surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000024465

Enrollment

500

Registered

2016-10-18

Start date

2016-10-20

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

gastric cancer

Interventions

Administration of Methylprednisolone Sodium Succinate 5mg/kg No administration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Primary gastric cancer 2) cStage II or III 3) Possible for R0 resection 4) Planned total, distal, or proximal gastrectomy 5) Aged 20 to 80 years old 6) PS(ECOG) of 0 or 1 7) Adequate organ functions defined as indicated below; WBC: 3000-12000/mm3 Platelet: 75000/mm3- AST: -100IU/L ALT: -100IU/L T-Bil: -2.0mg/dl Cr: -1.5mg/dl 8) Written informed consent from patient

Exclusion criteria

Exclusion criteria: 1) Emergency surgery 2) Uncontrollable diabetes mellitus or administration of insulin 3) Active infectious disease 4) Continuous steroid therapy 5) Past history of allergy for steroid 6) Past history of myocardial infarction or cerebral infarction 7) HBs antigen positive or HIV antibody positive 8) Enrolled in another interventional study which has severe impact on this study 9) Judged it inappropriate by physician

Design outcomes

Primary

Measure	Time frame
peak CRP value after surgery (phase II) recurrence-free survival (phase III)	—

Countries

Japan

Contacts

Public ContactYukinori Kurokawa

Osaka University Department of Gastroenterological Surgery

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

Outcome results

None listed

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