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Radical Gastrectomy With/Without HIPEC in Advanced Gastric Cancer Patients

NCT02381847 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-03-06

No results posted yet for this study

Summary

Patients with histological proven advanced gastric cancer (including cancer of the esophagogastric junction (AEG) without evidence of distant metastases, who fulfill the inclusion and exclusion criteria, can be recruited in this study. There are two treatment groups (A and B). The D2 radical gastrectomy will be applied in both groups. Patients randomized into group B will be treated with an intraperitoneal (in the abdominal cavity) chemoperfusion with cisplatin(75mg/m2 max 150mg/m2 max 5L ). Patients randomized into group A will not accept intraperitoneal chemoperfusion. Patients in both groups receive 6 cycles of postoperative chemotherapy (SOX or XELOX) within 4-12 weeks after the surgical procedure and are followed up for 24 months.

Conditions

  • Malignant Neoplasm of Stomach

Interventions

PROCEDURE

intraperitoneal chemoperfusion

HIPEC with cisplatin at the time of D2 radical surgery

Sponsors & Collaborators

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    lead OTHER

Principal Investigators

  • Wenxian Guan · China Health Ministry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2017-03-31
Completion
2020-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02381847 on ClinicalTrials.gov