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Trial Title:
Sequential HIPEC of Oxaliplatin and Paclitaxel for Gastric Cancer Patients With Peritoneum Metastasis
NCT ID:
NCT01471132
Condition:
Gastric Cancer
Metastases to Perineum
Conditions: Official terms:
Neoplasm Metastasis
Stomach Neoplasms
Paclitaxel
Oxaliplatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
Oxaliplatin 345mg/m2,43℃，30mins
Arm group label:
HIPEC
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Paclitaxel 260mg/m2,43℃，30mins
Arm group label:
HIPEC
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:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Start date:
September 2011
Completion date:
September 2015
Lead sponsor:
Agency:
Peking University
Agency class:
Other
Source:
Peking University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01471132
