Stomach Neoplasms Clinical Trial
Official title:
The Study of Intraperitoneal Docetaxel Plus S-1 for Malignant Ascites Due to Far Advanced Gastric Cancer
Verified date | January 2017 |
Source | Fudan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a clinical Study to evaluate the effect, survival benefit and safety of intraperitoneal docetaxel combined with oral S-1 for advanced gastric cancer with malignant ascites.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | June 2018 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Age 20-75years 2. Histologic confirmation of gastric adenocarcinoma 3. Positive peritoneal cytology or histological proven PM 4. Ascites in CT scan 5. Performance status (PS) = 2 on Eastern Cooperative Oncology Group (ECOG) scale 6. Adequate bone marrow and organ functions as defined below: Leucocyte=3,000/ul Absolute neutrophil counts =1,500/uL Platelet=100,000/uL Total bilirubin=1.5mg/dl ALT,AST= 2x ULN serum creatinine =1.5mg/dl 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 8. Provision of written informed consent Exclusion Criteria: 1. Presence of non-curable factors such as distant metastasis to liver or lung except of peritoneum 2. Other severe medical conditions such as symptomatic infectious disease,active hemorrhage/bleeding, or obstructive bowel disease 3. Life expectation = 3 months 4. With other malignant tumor 5. allergy to therapeutic drugs |
Country | Name | City | State |
---|---|---|---|
China | Huashan Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Fudan University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | response rate of ascites | From date of enrollment to three cycles of treatment,the ascites is evaluated by the Japanese conventional five-point method | 9 weeks | |
Secondary | one year survival rate | From date of enrollment until 1 year | 1 year | |
Secondary | side effects of chemotherapy | Grade refers to Common Terminology Criteria for Adverse Events(CTCAE)Version4.0 | 1 week to 18 weeks |
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