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Sequential HIPEC of Oxaliplatin and Paclitaxel for Gastric Cancer Patients With Peritoneum Metastasis
Conditions
Gastric Cancer - Metastases to Perineum
Conditions: official terms
Neoplasm Metastasis - Stomach Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Oxaliplatin
Type: Drug
Name: Paclitaxel
Type: Drug
Overall Status
Recruiting
Summary
The recurrence and metastasis of peritoneum is always the lethal consequence for gastric cancer patients, and there is no effective therapy until now. It has been reported by Dr.Fujimoto that intraperitoneal chemotherapy plus hyperthermic therapy, which called hyperthermic intraperitoneal chemotherapy (HIPEC), can eliminate and suppress the free cancer cells and tiny metastasis in abdomen. Refer to the experience of systematic chemotherapy, HIPEC with combination regimen would have a brighter prospect. In this study, the investigators would use Oxaliplatin and paclitaxel sequent as HIPEC regimen. The safety and overall survival would be observed and evaluated.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
- 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.
Location
Peking University Cancer Hospital
Beijing, Beijing, China
Status: Recruiting
Start Date
September 2011
Completion Date
September 2015
Sponsors
Peking University
Source
Peking University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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