Hyperthermic Intraperitoneal Chemotherapy for Advanced Gastric Cancer With Peritoneal Metastatis

July 20, 2018 updated by: Wei Wang, Guangdong Provincial Hospital of Traditional Chinese Medicine

A Randomized Controlled Clinical Trial of Hyperthermic Intraperitoneal Chemotherapy for Advanced Gastric Cancer With Peritoneal Metastatis

The incidence rate of gastric cancer is high in Southeast Asia, so is the mortality rate.Due to the lack of specific performance, about 5%-20% of patients have found peritoneal metastases at the time of first diagnosis.At present, clinical studies on HIPEC in the treatment of patients with advanced gastric cancer peritoneal metastasis are almost related to abdominal perfusion after laparoscopic gastrectomy.Herein, we conduct a single-centre randomized controlled trial to explore the safety and feasibility of laparoscopic exploration combined with HIPEC in the treatment of advanced gastric cancer with peritoneal metastasis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Gastric cancer is one of the most common digestive tumors in the world.In China, advanced gastric cancer with severe local progression or distant metastasis is more common.Gastric cancer with peritoneal carcinomatosis has an extremely poor prognosis,with a median survival of less than 6 months.Hyperthermic Intraperitoneal Chemotherapy (HIPEC) is currently a treatment for malignant tumors in the abdominal cavity and prevents tumor recurrence and metastasis.Studies have shown that hyperthermic intraperitoneal perfusion chemotherapy (HIPEC) has good clinical efficacy in the prevention and treatment of peritoneal metastasis of gastric cancer and its associated malignant ascites.Therefore,we conduct a single-centre randomized controlled trial to explore the safety and feasibility of HIPEC in the treatment of advanced gastric cancer with peritoneal metastasis. The metahnism of HIPEC is taking advantage of the difference in temperature sensitivity between cancer cells and normal cells. Perfusion of the abdominal cavity with a chemical fluid of the appropriate temperature can be performed. Suitable high temperatures can directly kill tumor cells.It is generally believed that the optimal temperature for the treatment of tumors is 42.5°C to 44°C.In this study,we set the temperature 43°C. Paclitaxel is a novel broad-spectrum antitumor drug,which has a unique anti-cancer mechanism.We use Paclitaxel as peritoneal hyperthermic perfusion chemotherapy drugs.The chemotherapy is SOX(Teggio and Oxaliplatin),.The primary endpoint is PFS. Secondary endpoints are one-year OS、canversion rate and ascites assessment. A phase III study PHOENIX-GC trial had finished enrollment,and the conclusion was the median OS 17.7 and 15.2 months respectively for IP and SP.The primary analysis did not show the statistical superiority of the IP regimen.The sensitivity analysis IP considering the imbalance of ascites, suggested clinical efficacy of IP PTX in gastric cancer with peritoneal metastasis. For this reason,we conduct a trial to explore the safety and feasibility of HIPEC in the treatment of advanced gastric cancer with peritoneal metastasis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jin Wan
        • Principal Investigator:
          • Wen jun Xiong
        • Principal Investigator:
          • Yan sheng Zheng
        • Principal Investigator:
          • Li jie Luo
        • Principal Investigator:
          • De chang Diao
        • Principal Investigator:
          • Hong ming Li
        • Principal Investigator:
          • Yao bin He

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primary gastric adenocarcinoma diagnosed pathologically by endoscopic biopsy；
  • Laparoscopic exploration of patients with advanced gastric adenocarcinoma of peritoneal metastasis；
  • Eastern Cooperative Oncology Group (ECOG): 0 ot 1；
  • American Society of Anesthesiologists （ASA） score: I to Ⅲ；
  • Patient informed consent。

Exclusion Criteria:

  • Pregnancy or female in suckling period；
  • Severe mental illness；
  • Preoperative imaging or intraoperative exploration reveals distant blood, liver, lung, and brain metastases；
  • 5 years of history of other malignant diseases；
  • A history of unstable angina or myocardial infarction within 6 months；
  • History of cerebral infarction or cerebral hemorrhage within 6 months；
  • A history of sustained systemic corticosteroid treatment within 1 month；
  • Emergency operation due to complication (bleeding, perforation or obstruction) caused by primary tumor；
  • Pulmonary function test FEV1 <predicted value 50%。

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HIPEC and chemotherapy
Hyperthermic Intraperitoneal Chemotherapy and SOX（Tiggio+Oxaliplatin ）
Drug: Hyperthermic Intraperitoneal Chemotherapy
The investigators use Paclitaxel as peritoneal hyperthermic perfusion chemotherapy drugs，75mg/m2 for the first time，50mg/m2 for the second time and third time.The chemotherapy is SOX(Tiggio d1-d14 bid po and Oxaliplatin 130mg/m2 ivd d1 qd).The Tiggio dosage depends on the patient's body surface area, body surface area <1.25m2 40mg/time, 1.25-1.50m2 50mg/time, >1.50m2 60mg/time.
Sham Comparator: Without HIPEC
Without Hyperthermic Intraperitoneal Chemotherapy，Only SOX（Tiggio+Oxaliplatin ）
Drug: Without Hyperthermic Intraperitoneal Chemotherapy
The chemotherapy is SOX(Tiggio d1-d14 bid po and Oxaliplatin 130mg/m2 ivd d1 qd).The Tiggio dosage depends on the patient's body surface area, body surface area <1.25m2 40mg/time, 1.25-1.50m2 50mg/time, >1.50m2 60mg/time.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: From date of randomization until the date of first documented progression or date of death for tumor cause, whichever came first, assessed 7 months
Progression-free survival
From date of randomization until the date of first documented progression or date of death for tumor cause, whichever came first, assessed 7 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
1-year survival
Time Frame: one year
1-year overall survival rate
one year
Ascites assessment
Time Frame: Intraoperative
Ascites assessment during surgery
Intraoperative
Median survival
Time Frame: From date of randomization until only 50% of individuals living for tumor cause, assessed 2 years
Median Survival Time
From date of randomization until only 50% of individuals living for tumor cause, assessed 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guangdong Provincial Hospital of Traditional Chinese Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wei Wang, Guangdong Provincial Hospital of Traditional Chinese Medicine
  • Principal Investigator: Wenjun Xiong, Guangdong Provincial Hospital of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 24, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 24, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GDPHCM-GI-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The data has not been published.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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