large type 3 or type 4 gastric cancer
Conditions
Interventions
Intervention type:DRUG
Name of intervention:SPP-005(20 mg/kg)
Dose form / Japanese Medical Device Nomenclature:GRANULES
Route of administration / Site of application:ORAL
Dose per administration:20 mg
Sponsors
Osaka University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ratio of patients who were diagnosed peritoneal metastasis detected only by ALA photodynamic diagnosis | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Adverse event rate with each CTCAE grade Sensitivity , specificity, positive predictive value, negative predictive value | — |
Countries
Japan
Contacts
Public ContactTsuyoshi Takahashi
Osaka University Hospital
Outcome results
None listed