Status:
UNKNOWN
Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Locally Advanced Gastric Cancer
Lead Sponsor:
Wuhan University
Conditions:
Malignant Neoplasm of Stomach
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The efficacy of HIPEC in prevention of local recurrence, distant metastasis or peritoneal metastasis in locally advanced gastric cancer is not definite. The hypothesis of the trial is that radical gas...
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 neoadjuvant che...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04345770
Start Date
April 1 2020
End Date
May 31 2025
Last Update
April 14 2020
Active Locations (1)
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1
Wuhan University
Wuhan, Hubei, China