The efficacy and safety of photodynamic diagnosis with SPP-005 at staging laparoscopy for advanced gastric cancer. Prospective multi-center trial. - GCPDD Study

Osaka University Hospital0 sites105 target enrollmentSeptember 15, 2017

Overview

No summary available.

Registry

who.int

Start Date

September 15, 2017

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\)Age older than 20 years
•2\)large type 3 whose size is over 8 cm or type 4 gastric cancer
•3\)ECOG Performance Status 0\~1
•4\)Patients with any abnormal function in kidney, liver, blood, heart or lung.
•5\)Patients in treatment without other tumors.
•6\)Patient in well compliance with protocol and with written informed consent.
•7\)Patients who are able to visit the hospital according to the protocol schedule.

•1\)Patient who is apparently diagnosed peritoneal dissemination by CT scan.
•2\)Patient having difficulty in oral ingestion
•3\)Patient with poor controlled infection
•4\)Patient with severe complications e.g. malignant hypertension, severe cardiac failure congestive, severe or unstable angina, myocardial infarction within last three months, cirrhosis in terminal stage, severe renal failure, diabetes mellitus poor control, severe pulmonary fibroses, active interstitial pneumonia, and so on.
•5\)Patients with current bone marrow transplantation
•6\)Patient with severe mental disorder
•7\)Patient with known allergy to 5\-ALA or a similar compound
•8\)Participation in other clinical studies with investigational drugs concurrently
•9\)Patients during pregnancy/lactation period
•10\)Patient is not judged exclusive by investigator