Back to resultsSequential HIPEC of Oxaliplatin and Paclitaxel for Gastric Cancer Patients With Peritoneum Metastasis (SHOP-G01)
Primary Purpose
Gastric Cancer, Metastases to Perineum
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Oxaliplatin
Paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer
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.
Sites / Locations
- Peking University Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HIPEC
Arm Description
Outcomes
Primary Outcome Measures
Overall Survival
Secondary Outcome Measures
Safety
Number of Participants with Adverse Events(III or IV grades according to NCI-CTC)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01471132
Brief Title
Sequential HIPEC of Oxaliplatin and Paclitaxel for Gastric Cancer Patients With Peritoneum Metastasis
Acronym
SHOP-G01
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
September 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Metastases to Perineum
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HIPEC
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
Oxaliplatin 345mg/m2,43℃，30mins
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel 260mg/m2,43℃，30mins
Primary Outcome Measure Information:
Title
Overall Survival
Time Frame
every 3 month postoperation up to 24 months
Secondary Outcome Measure Information:
Title
Safety
Description
Number of Participants with Adverse Events(III or IV grades according to NCI-CTC)
Time Frame
every 3 month postoperation up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaojiang Wu
Phone
8601088196598
Email
wu.xiaojiang@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiafu Ji
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Peking University Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Sequential HIPEC of Oxaliplatin and Paclitaxel for Gastric Cancer Patients With Peritoneum Metastasis
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