The efficacy and safety of photodynamic diagnosis with SPP-005 at staging laparoscopy for advanced gastric cancer. Prospective multi-center trial.
- Conditions
- large type 3 or type 4 gastric cancer
- Registration Number
- JPRN-jRCT2091220309
- Lead Sponsor
- Osaka University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The ratio of patients who were diagnosed peritoneal metastasis detected only by ALA photodynamic diagnosis
- Secondary Outcome Measures
Name Time Method Incidence of Adverse event rate with each CTCAE grade<br>Sensitivity , specificity, positive predictive value, negative predictive value