- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02528110
Radical Gastrectomy and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Locally Advanced Gastric Cancer
A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of Locally Advanced Gastric Cancer During Radical Gastrectomy
Study Overview
Status
Conditions
Detailed Description
To determine the efficacy of HIPEC in the treatment of locally advanced gastric cancer, patients are randomized into HIPEC group and control group. In HIPEC group, the patients undergo radical gastrectomy with D2 lymphadenectomy and HIPEC with paclitaxel and 5-Fu. Patients in the control group just undergo radical gastrectomy with D2 lymphadenectomy. Patients in both groups receive 6 cycles of postoperative chemotherapy (SOX or XELOX) and are followed up for 5 years or until death.
The trial is designed as a prospective, randomized, open, multicenter and parallel group study.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430021
- Zhongnan Hospital of Wuhan University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histological proved diagnosis of locally advanced gastric cancer.
- No evidence of distant metastases or peritoneal metastases.
- Preoperative examination (CT/MRI) demonstrated resectable gastric cancer with T3-T4 stage.
- Eligible for radical gastrectomy with D2 lymphadenectomy.
- Have not received cytotoxic chemotherapy or radiotherapy.
- Written informed consent is obtained prior to commencement of trial treatment.
Exclusion Criteria:
- Existence of distant metastasis or peritoneal metastasis during surgery (M1).
- Any previous chemotherapy or radiotherapy
- Active systemic infections
- Inadequate cardiac function, renal function, liver function or bone marrow function at the beginning of the trial.
- Female patients who are pregnant or breast feeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Radical gastrectomy without HIPEC
Patients will be treated with a D2 radical gastrectomy for locally advanced gastric cancer and postoperative chemotherapy (SOX or XELOX)
|
radical gastrectomy with D2 lymphadenectomy
Oxaliplatin 130mg/m2 d1, Tegafur,Gimeracil and Oteracil Porassium Capsules 60mg, d1-14.
Oxaliplatin 130mg/m2 d1, Capecitabine 1000mg/m2 d1-14.
|
Experimental: Radical gastrectomy with HIPEC
Patients will be treated with a D2 radical gastrectomy for locally advanced gastric cancer and HIPEC with paclitaxel and 5-Fu and postoperative chemotherapy (SOX or XELOX)
|
radical gastrectomy with D2 lymphadenectomy
Oxaliplatin 130mg/m2 d1, Tegafur,Gimeracil and Oteracil Porassium Capsules 60mg, d1-14.
Oxaliplatin 130mg/m2 d1, Capecitabine 1000mg/m2 d1-14.
Normal saline 3000ml-4000ml, Paclitaxel 75mg/m2, 5-Fu 15mg/m2, 43°C, 60min.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall survival
Time Frame: 5 years
|
From the date of surgery to the date of death or to the end of follow-up
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
progression-free survival
Time Frame: 5 years
|
5 years
|
distant metastasis rate
Time Frame: 5 years
|
5 years
|
peritoneal metastasis rate
Time Frame: 5 years
|
5 years
|
local recurrence rate
Time Frame: 5 years
|
5 years
|
complication rate
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WuhanU_HIPEC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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