Phase 2 Study of Sequential Hyperthermic Intraperitoneal Chemotherapy of Oxaliplatin and Paclitaxel for Gastric Cancer Patients With Peritoneum Metastasis or Positive Free Cancer Cells in Abdomen
Phase 2
18 Years
70 Years
18 Years
70 Years
Open (Enrolling)
Both
Gastric Cancer, Metastases to Perineum
Both
Gastric Cancer, Metastases to Perineum
Trial Information
Phase 2 Study of Sequential Hyperthermic Intraperitoneal Chemotherapy of Oxaliplatin and Paclitaxel for Gastric Cancer Patients With Peritoneum Metastasis or Positive Free Cancer Cells in Abdomen
Inclusion Criteria:
- Histologically proved gastric adenocarcinoma.
- Peritoneum metastasis is observed or suspected by laparoscopy or radiologic
examination,or free cancer cells are detected in peritoneal lavage liquid.
- Potentially resectable gastric cancer.
- ALT, AST < 80U/L; Total Bilirubin < 30μmol/L; WBC > 4x10^9/L; PLT > 100x10^9/L; Cr <
1.5 fold normal value.
- ECOG 0-2 points.
- Expected survival time longer than 3 months.
- Informed consent.
Exclusion Criteria:
- Recurrent gastric cancer.
- Pregnant or lactating women.
- Allergic to oxaliplatin or paclitaxel.
- Abnormal liver/kidney function.
- Serious heart/metabolic disease.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Survival
Outcome Time Frame:
every 3 month postoperation up to 24 months
Safety Issue:
No
Principal Investigator
Jiafu Ji
Investigator Role:
Study Chair
Investigator Affiliation:
Peking University Cancer Hospital
Authority:
China: Ethics Committee
Study ID:
HIPEC-GCOT
NCT ID:
NCT01471132
Start Date:
September 2011
Completion Date:
September 2015
Related Keywords:
- Gastric Cancer
- Metastases to Perineum
- Stomach Neoplasms
- Neoplasm Metastasis
- Neoplasms, Second Primary
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