Skip to content

Peri-operative chemotherapy with intraperitoneal and intravenous Paclitaxel plus TS-1 for serosa positive gastric cancer patients

Peri-operative chemotherapy with intraperitoneal and intravenous Paclitaxel plus TS-1 for serosa positive gastric cancer patients - GAPS study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013109
Enrollment
50
Registered
2014-02-21
Start date
2014-05-01
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

serosa positive gastric cancer

Interventions

intraperitoneal and intravenous Paclitaxel plus TS-1

Sponsors

Intraperitoneal chemotherapy study group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (i) Histologically proven common gastric carcinoma (ii) Suspected serosa invasive gastric cancer (iii) There must be an absence of peritoneal metastasis or negative finding from peritoneal washing cytology confirmed by staging laparoscopy (iv) The patient must have clinically resectable gastric cancer (v) Tumor invasion of the esophagus must be less than 3 cm, (vi) Patients must be in the age range 20-75 years (vii) The Eastern Cooperative Oncology Group performance status must be 0 or 1 (viii) No previous therapy against GC should have been carried out, and no previous chemotherapy, CRT or radiotherapy (ix) No typical bleeding from GC and stenosis of gastro-intestinal tract should have occurred (x) Sufficient oral intake is required (xi) Written informed consent will be obtained from all patients (xii) Adequate organ functions are required

Exclusion criteria

Exclusion criteria: (i) The occurrence of simultaneous or metachronous (within 5 years) double cancers, with the exception of intramucosal tumor that is curable with local therapy (ii) A history of severe drug hypersensitivity (iii) The presence of active bacterial or fungal infection, and a body temperature over 38 temperature. (iv) Pregnancy or lactation in women of childbearing potential (v) Men who wish the partners pregnancy (vi) The presence of unstable angina, heart failure or a history of myocardial infarction within 6 months (vii) Patients requiring systemic steroid medication (viii) Patients requiring the administration of phenytoin or warfarin potassium (ix) The presence to peptic ulcer or bleeding (x) The presence of severe diarrhea (xi) The presence of antigen-positive serum HBs and/or antibody positive serum HVC (xii) The presence of uncontrollable intestinal paralysis, interstitial pneumonitis or ischemic heart disease (xiii) Patients determined to be inappropriate for this study

Design outcomes

Primary

MeasureTime frame
percent completion of protocol treatment

Countries

Japan

Contacts

Public ContactMotohiro Imano

Kinki University Faculty of Medicine Department of Surgery

imano@med.kindai.ac.jp072-366-0221

Outcome results

None listed

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