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OpenTrials
Completed

NCT Number: NCT02528110

Radical Gastrectomy and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Locally Advanced Gastric Cancer

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 gastrectomy plus HIPEC is superior to only radical gastrectomy in terms of overall survival.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430021, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyperthermic intraperitoneal chemotherapy (HIPEC)

Procedure

Normal saline 3000ml-4000ml, Paclitaxel 75mg/m2, 5-Fu 15mg/m2, 43°C, 60min.

D2 radical gastrectomy

Procedure

radical gastrectomy with D2 lymphadenectomy

SOX postoperative chemotherapy

Other

Oxaliplatin 130mg/m2 d1, Tegafur,Gimeracil and Oteracil Porassium Capsules 60mg, d1-14.

XELOX postoperative chemotherapy

Other

Oxaliplatin 130mg/m2 d1, Capecitabine 1000mg/m2 d1-14.

Primary outcomes

  1. overall survival

    Time frame: 5 years

    From the date of surgery to the date of death or to the end of follow-up

Secondary outcomes

  1. progression-free survival

    Time frame: 5 years

  2. distant metastasis rate

    Time frame: 5 years

  3. peritoneal metastasis rate

    Time frame: 5 years

  4. local recurrence rate

    Time frame: 5 years

  5. complication rate

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Wuhan University

Other

Registry information

Official study title

A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of Locally Advanced Gastric Cancer During Radical Gastrectomy

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Aug 19, 2015
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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