KCT0005802
Not yet recruiting
未知
Phase I,II Study of first line Intraperitoneal Paclitaxel with Systemic Capecitabine and Oxaliplatin Combination Therapy in Patients with Advanced Gastric Cancer with Peritoneal Metastasis
The Catholic University of Korea, Seoul St. Mary's Hospital0 sites61 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- The Catholic University of Korea, Seoul St. Mary's Hospital
- Enrollment
- 61
- Status
- Not yet recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) age 20 to 80 years
- •2\) ECOG(Eastern Cooperative Oncology Group) performance status 0 or 1
- •3\) Pathologically proven primary gastric adenocarcinoma
- •4\) Peritoneal metastasis confirmed by laparoscopy or diagnostic imaging
- •5\) Written informed consent
- •6\) Adequate function of important organs (within 14 days before registration)
- •Absolute neutrophil count \=1\.5 x 10^9/L
- •Platelet \>\=100,000/mm3
- •Hemoglobin \>\=8\.0g/dL
- •T\-Bilirubin \<\= \= 2\.0mg/dl or ULN x 1\.5
Exclusion Criteria
- •1\) Other active concomitant malignancies
- •2\) HER2 positive (Immunohistochemostry 3\+ or 2\+ with in situ hybridization positive)
- •3\) No investigational anticancer therapy within 30 days prior to the first dose of study treatment
- •4\) recent (within 6 months) acute coronary syndrome, severe heart failure or severe pulmonary disease
- •5\) uncontrolled acute or chronic disease
- •6\) uncontrolled infection or inflammation
- •7\) uncontrolled psychiatric disorder or central neurologic disease
- •8\) not fully recovered from previous surgery
- •9\) prior anticancer therapy (chemotherapy, immunotherapy, radiation) within 6 months
- •10\) intolerable to oral administration or a lack of physical integration of the upper gastrointestinal tract or with a malabsorption syndrome
Outcomes
Primary Outcomes
Not specified
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