Sequential HIPEC of Oxaliplatin and Paclitaxel for Gastric Cancer Patients With Peritoneum Metastasis

Phase 2

• Conditions: Gastric Cancer; Metastases to Perineum
• Interventions: Drug: Oxaliplatin; Drug: Paclitaxel

• Registration Number: NCT01471132
• Lead Sponsor: Peking University

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-11-01
• Study First Submitted QC: 2011-11-10
• Study First Posted: 2011-11-11
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-06
• Last Update Posted: 2012-12-07
• Primary Completion: 2013-09
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

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Exclusion Criteria

• Recurrent gastric cancer.
• Pregnant or lactating women.
• Allergic to oxaliplatin or paclitaxel.
• Abnormal liver/kidney function.
• Serious heart/metabolic disease.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HIPEC	Oxaliplatin	-
HIPEC	Paclitaxel	-

Primary Outcome Measures

Name	Time	Method
Overall Survival	every 3 month postoperation up to 24 months

Secondary Outcome Measures

Name	Time	Method
Safety	every 3 month postoperation up to 24 months	Number of Participants with Adverse Events(III or IV grades according to NCI-CTC)

Trial Locations

Locations (1)

Peking University Cancer Hospital; 🇨🇳 Beijing, Beijing, China