Efficacy of HIPEC in the Treatment of Locally Advanced Gastric Cancer After radIcal Gastrectomy With D2

Last updated: October 29, 2017
Sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Overall Status: Active - Recruiting

Phase

3

Condition

Stomach Cancer

Digestive System Neoplasms

Gastric Cancer

Treatment

N/A

Clinical Study ID

NCT02356276
HIPEC-01
  • Ages 18-70
  • All Genders

Study Summary

HIPEC-01 is a prospective, open, randomized multicenter phase III clinical study conducted in China. To determine the efficacy of hyperthermic intraperitoneal chemotherapy (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 postoperative chemotherapy. Patients in the control group just undergo radical gastrectomy with D2 lymphadenectomy followed by postoperative chemotherapy. Patients in both groups receive 6-8 cycles of postoperative systemic chemotherapy (XELOX or SOX regimens) and are followed up for 5 years or until death.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 < age ≤ 70 years old

  • Male or Non pregnant female

  • The Eastern Cooperative Oncology Group (ECOG) status 0-1

  • T3 or T4 gastric adenocarcinoma (visual determination according to AJCC 2010 7thedition)

  • No distance metastasis, eligible for D2 lymphadenectomy

  • Have not received cytotoxic chemotherapy, radiotherapy or immunotherapy

  • White blood cells > 4,000/mm3

  • neutrophils ≥ 1,500/mm3

  • platelets ≥ 100,000/mm3

  • hemoglobin>9g/l

  • Alanine transaminase (ALT) and aspartate aminotransferase (AST) < or = 2.5 times upperlimit of nominal (ULN)

  • total bilirubin (TBIL) < 1.5 times ULN

  • serum creatinine < 1 times ULN

  • Having given written informed consent prior to any procedure related to the study

Exclusion

Exclusion Criteria:

  • Have other cancer within 5 years

  • Existence of distance metastasis during surgey (M1)

  • Prior malignant tumors with detectable signs of recurrence or distant metastasis

  • Poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiacinsufficiency, persistent hypertension despite medicinal treatment, ejectionfraction<50%

  • Epileptic seizures patients need medicine control

  • Uncontroled mental disease or mental disorder

  • Drug abuse or psychological or social factors affect the judgment of results

  • Contraindication to any therapy contained in this regimen specific to the study

  • Receiving other chemotherapy, radiotherapy or immunotherapy

  • Without given written informed consent

Study Design

Total Participants: 584
Study Start date:
May 11, 2015
Estimated Completion Date:
January 31, 2022

Study Description

Gastric cancer (GC) is the fourth most common cancer, and the second leading cause of cancer-related death worldwide. Advances in diagnostic and therapeutic approaches have achieved long-term survival for early GC. However, receiving perioperative/postoperative systemic chemotherapy and gastrectomy with D1-D2 lymph node dissection, 5-year survival rates of advanced gastric cancer remain under 30%. 40-60% of recurrences are peritoneal and/or locoregional. hyperthermic intraperitoneal chemotherapy (HIPEC) technique is increasingly used in the curative treatment of primary and digestive peritoneal carcinomatosis, in association with cytoreductive surgery. Theoretically, HIPEC eliminates free cancer cells that can be released into peritoneal cavity during the gastrectomy and prevents peritoneal carcinomatosis recurrences. The benefit of using HIPEC as an adjuvant treatment for advanced gastric cancer has been reported in several randomized studies and a meta-analysis. Surgical resection combined with HIPEC significantly reduces the peritoneal recurrences and improves the overall survival of GC patients. But there is not a prospective and randomized phase III clinical study of HIPEC in the treatment of locally advanced gastric cancer after radical surgery in China so far.

In order to evaluate the survival benefit and safety of radical surgery and HIPEC followed by postoperative chemotherapy in local advanced gastric cancer, patients who fulfill the inclusion and exclusion criteria will be recruited in this study and randomized to two treatment groups (HIPEC group and control group). In HIPEC group, the patients undergo radical gastrectomy with D2 lymphadenectomy and HIPEC with paclitaxel and postoperative chemotherapy. Patients in the control group just undergo radical gastrectomy with D2 lymphadenectomy followed by postoperative chemotherapy. Patients in both groups receive 6-8 cycles of postoperative systemic chemotherapy (XELOX or SOX regimens) . Patients are followed up for 5 years and the survival outcome will be analyzed.

Connect with a study center

  • Chinese PLA General Hospital

    Beijing, Beijing 100853
    China

    Active - Recruiting

  • Affiliated Tumor Hospital of Guangzhou Medical University

    Guangzhou, Guangdong 510095
    China

    Active - Recruiting

  • Guangdong General Hospital

    Guangzhou, Guangdong 510080
    China

    Active - Recruiting

  • Guangdong Provincial Hospital of Traditional Chinese Medicine

    Guangzhou, Guangdong 510120
    China

    Active - Recruiting

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong 510515
    China

    Active - Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

  • Hebei Medical University Fourth Hospital

    Shijiazhuang, Hebei 050011
    China

    Active - Recruiting

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei 050000
    China

    Active - Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang 150081
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan 450008
    China

    Active - Recruiting

  • Wuhan Union Hospital, China

    Wuhan, Hubei 430030
    China

    Active - Recruiting

  • The second Xiangya Hospital of Central South University

    Changsha, Hunan 410011
    China

    Active - Recruiting

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin 300060
    China

    Active - Recruiting

  • Zhejiang Cancer Hospital

    Hanzhou, Zhejiang 310022
    China

    Active - Recruiting

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