The safety and efficacy of photodynamic diagnosis with SPP-006 at staging laparoscopy for advanced gastric cancer. Prospective multi-center trial. - ALAP Study

Osaka University Hospital0 sites30 target enrollmentOctober 26, 2015

Overview

No summary available.

Registry

who.int

Start Date

October 26, 2015

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•Japanese patients who meet all of the following criteria are included in this clinical trial.
•1\)Age older than 20 years
•2\)Macroscopic finding is type 4 or type 3 whose size is over 8 cm by endoscopy and/or CT
•3\) ECOG Performance Status 0\-1
•4\)Patients without 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.

•Patients who meet any of the following criteria are excluded from this trial
•1\) Patient with poor controlled infection
•2\)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.
•3\) Patients with current bone marrow transplantation
•4\) Patient with severe mental disorder
•5\) Patient with known allergy to 5\-ALA or a similar compound
•6\) Participation in other clinical studies with investigational drugs concurrently
•7\) Pregnant or breast\-feeding
•8\) Patient is judged exclusive by investigator