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Comparison of the Efficiency Between Intraoperative and Postoperative Hyperthermic Intraperitoneal Chemotherapy With Docetaxel Combine Oxaliplatin in Patients With Advanced Gastric Cancer

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ClinicalTrials.gov Identifier: NCT04522011
Recruitment Status : Not yet recruiting
First Posted : August 21, 2020
Last Update Posted : August 21, 2020
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

Study Description
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Brief Summary:
Advanced gastric cancer has always been the focus and difficulty in the treatment of gastric cancer, and postoperative peritoneal recurrence is one of the key factors with poor prognosis. in recent years, hyperthermic intraperitoneal chemotherapy has been used in the treatment of advanced peritoneal metastases and achieved remarkable results. Existing studies have shown that postoperative hyperthermic intraperitoneal chemotherapy plays a certain role in reducing postoperative peritoneal recurrence of advanced gastric cancer. Our previous studies have shown that hyperthermic intraperitoneal chemotherapy adopted docetaxel combine oxaliplatin can also reduce the peritoneal recurrence of advanced gastric cancer. At present, there is a lack of comparison of the safety and efficacy of intraoperative and postoperative hyperthermic intraperitoneal chemotherapy. In this study, patients with advanced gastric cancer were selected by preoperative imaging, endoscopic ultrasonography and other examinations. The patients were randomly divided into group A: D1-2 radical gastrectomy plus hyperthermic intraperitoneal chemotherapy of docetaxel + oxaliplatin. Group B: D1-2 radical gastrectomy + postoperative hyperthermic intraperitoneal chemotherapy of docetaxel + oxaliplatin and group C: D1-2 radical radical gastrectomy .The three groups both proceed postoperative conventional adjuvant chemotherapy（SOX/XELOX）.The incidence of postoperative anastomotic leakage and other complications were collected, and the safety differences among the three groups were compared. The three-year overall survival (OS), disease-free survival (PFS), and disease-related mortality were evaluated and the long-term effects among the three groups were compared.

Condition or disease Intervention/treatment
Stomach Neoplasms Hyperthermic Intraperitoneal Chemotherapy Other: intraoperative or postoperative hyperthermic intraperitoneal chemotherapy

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Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Comparison of the Efficiency Between Intraoperative and Postoperative Hyperthermic Intraperitoneal Chemotherapy With Docetaxel Combine Oxaliplatin in Patients With Advanced Gastric Cancer
Estimated Study Start Date : January 1, 2021
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : February 28, 2023

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Group A
D1/2 radical gastrectomy combines intraoperative hyperthermic intraperitoneal chemotherapy with docetaxel + oxaliplatin
 Other: intraoperative or postoperative hyperthermic intraperitoneal chemotherapy
Intraoperative hyperthermic intraperitoneal chemotherapy：Use docetaxel + oxaliplatin Intraoperately.(Docetaxel 30mg/m2 + oxaliplatin 30mg/m2), perfusion at 43 ℃ for 1 hour
Group B
D1/2 radical gastrectomy combines postoperative hyperthermic intraperitoneal chemotherapy with docetaxel + oxaliplatin
 Other: intraoperative or postoperative hyperthermic intraperitoneal chemotherapy
Intraoperative hyperthermic intraperitoneal chemotherapy：Use docetaxel + oxaliplatin Intraoperately.(Docetaxel 30mg/m2 + oxaliplatin 30mg/m2), perfusion at 43 ℃ for 1 hour
Group
without hyperthermic intraperitoneal chemotherapy


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival（0S） [ Time Frame: 1 month ]
    The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive. In a clinical trial, measuring the overall survival is one way to see how well a new treatment works. Also called OS.

  2. Progression-free survival [ Time Frame: 1 month ]
    The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the PFS is one way to see how well a new treatment works. Also called progression-free survival.

  3. The incidence of postoperative complications [ Time Frame: through study completion, an average of 1 month ]
    The incidence of medical problems that occurs after surgery


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who was diagnosed with gastric adenocarcinoma by pathology in the first affiliated Hospital of Jiaotong University since November 2019.
Criteria

Inclusion Criteria:

  • 1.Patients with gastric adenocarcinoma diagnosed pathologically from 18 to 65 years old.
  • 2.Transthoracic and abdominal contrast-enhanced CT and endoscopic ultrasonography were diagnosed as cT3 / T4 N (+).
  • 3.There are no obvious surgical taboos in cardiopulmonary function and blood coagulation.
  • 4.Ability to provide informed consent

Exclusion Criteria:

  • 1.Physical strength score ZPS > = 2.
  • 2.Distant metastasis
  • 3.Pregnant or lactating.
  • 4.Have serious chronic diseases (hypertension, diabetes, etc.).
  • 5.Allergic to chemotherapeutic drugs.
  • 6.Poor compliance
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04522011


Contacts
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Contact: Kun Zhu 0086-18991232539 dr.zhkun@mail.xjtu.edu.cn
Contact: Kun Zhu 0086-18991232539 dangchengxue@mail.xjtu.edu.cn

Locations
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China, Shannxi
Kun Zhu
Xi'an, Shannxi, China, 710061
Contact: Kun Zhu         
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Investigators
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Study Chair: Kun Sun First Affiliated Hospital Xi'an Jiaotong University
More Information
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Publications:

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Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT04522011    
Other Study ID Numbers: XJTU1AF-CRF-2019-028
First Posted: August 21, 2020    Key Record Dates
Last Update Posted: August 21, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stomach Neoplasms
Hyperthermia
Fever
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Body Temperature Changes
Heat Stress Disorders
Wounds and Injuries