INtraPeritoneal Administration of ChemoTherapeutic agent Trial
Phase 2
- Conditions
- gastric cancer (large type 3 or type 4 cancer, or cancer with CY1 or P1 status who nevertheless will be treated by gastrectomy)
- Registration Number
- JPRN-UMIN000002957
- Lead Sponsor
- on profit organization ECRI
- Brief Summary
Intraperitoneal administration of paclitaxel was safely conducted with minimal adverse events. However, there was no significant difference in progression-free survival and overall survival between the two arms.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
1) Serious cardiac, hepatic, and pulmonary comorbidities or uncontrollable diabetes mellitus. Active gastrointestinal bleeding or bowel obstruction 2) Active second malignancy either found simultaneously or within 5 years from the diagnosis of gastric cancer 3) Suffering from infection 4) Under steroid therapy 5) Has wishes to become pregnant 6) Under mental disorder 7) allergy to the ingredients of paclitaxel injection 8) severe drug allergy 9) Peripheral neural disorder
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method