Nonintervention Study on Peritoneal Metastasis of Stage IV Gastric Cancer

July 31, 2017 updated by: Wang Kuan, M.D.Prof, Harbin Medical University

Prospective and Non-interventional Study on Peritoneal Metastasis of Stage IV Gastric Cancer

This is a non-interventional study，aim to observe the safety and efficiency of different treatment regimen for peritoneal metastasis of Stage IV gastric cancer in the real world

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

110

Contacts and Locations

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

Study Locations

  • China
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Harbin Medical University Cancer Hospital

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

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with histologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma, stage IV with peritoneal metastasis

Description

Inclusion Criteria:

  • 18 ≤ age
  • Patients with histologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma, stage IV with peritoneal metastasis
  • Didn't received any prior systemic chemotherapy
  • Signed informed consent

Exclusion Criteria:

  • History of hypersensitivity to fluoropyrimidines, Tegafur，Gimeracil and Oteracil Potassium Capsules , capecitabine, oxaliplatin or the ingredients of this product
  • Pregnancy or lactation women,
  • Inadequate hematopoietic function： WBC≦3,500/mm3; ANC≦1,500/mm3; Platelet≦80,000/mm3
  • Inadequate organ function which is defined as below:

Total bilirubin >2 pper limit of normal range (ULN); ALT / AST > 2.5 upper limit of normal range (ULN); serum creatinine > 1.5 mg/dL, and Ccr > 60 ml/min (estimated by Cockcroft-Gault formulation);

  • Symptomatic peripheral neuropathy
  • Receiving a concomitant treatment with other fluoropyrimidines
  • Fluoropyrimidines (DPD) congenital absence
  • Other Situations which physicians suggesting are inadaptable for enrollment

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Chemotherapy Group
chemotherapy treatment（S-1 and Oxaliplatin） for patients until disease progress
Drug: S-1
40-60mg/m^2 bid, days 1-14, oral，every 3 weeks.
Drug: oxaliplatin
100mg/m^2 days 1，intravenous infusion, every 3 weeks.
Chemotherapy plus HIPEC Group
Hyperthermic Intraperitoneal chemoperfusion（HIPEC）with Paclitaxel more than 2 cycles and plus chemotherapy
Drug: S-1
40-60mg/m^2 bid, days 1-14, oral，every 3 weeks.
Drug: oxaliplatin
100mg/m^2 days 1，intravenous infusion, every 3 weeks.
Device: Hyperthermic Intraperitoneal
hyperthermic intraperitoneal chemoperfusion
Drug: Paclitaxel
intraperitoneal perfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS: Progression Free Survival
Time Frame: through study completion, an average of 1 year
time from enrollment to disease progression or death
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS:overall survival
Time Frame: 3 years
time from enrollment to death
3 years
Safety
Time Frame: 3 years
measured by recording the subjects' Adverse Events according to CTCAE 4.03
3 years

Collaborators and Investigators

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

Sponsor

Harbin Medical University

Investigators

  • Principal Investigator: Kuan Wang, Harbin Medical University Cancer Hospital,Gastrointestinal Surgical department

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)

July 1, 2017

Primary Completion (ANTICIPATED)

June 1, 2019

Study Completion (ANTICIPATED)

June 1, 2020

Study Registration Dates

First Submitted

July 31, 2017

First Submitted That Met QC Criteria

July 31, 2017

First Posted (ACTUAL)

August 2, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 2, 2017

Last Update Submitted That Met QC Criteria

July 31, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOTPMSG1602

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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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