Study of Oxaliplatin, Irinotecan, and S-1 in Gastric Cancer

August 22, 2017 updated by: Hallym University Medical Center

Phase II Study of S-1 in Combination With Oxaliplatin and Irinotecan in Patients With Advanced, Recurrent or Metastatic Gastric Cancer

This study will conduct a phase II study of triple combination with oxaliplatin, irinotecan, and S-1 as the first-line chemotherapy in patients with advanced gastric cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

It is widely accepted that the efficacy of chemotherapy for patients with inoperable, advanced, and metastatic gastric cancer is better than that compared to best supportive care. In general, combination chemotherapies are more efficient than monotherapy and so it is reasonable to give combination chemotherapy to patients with good performance status.

Especially dual combination chemotherapy with fluoropyrimidine and platinum has shown the objective response rate of 25-48% in patients with newly diagnosed advanced metastatic gastric cancer and several studies about triple combination with oxaliplatin, irinotecan, and fluoropyrimidine have shown the response rate of 53~75% but also higher rate of hematologic adverse events. So the investigators had conducted the phase I study of these three drugs with modification of dosage and schedule and will conduct a phase II study with recommended dose of triple chemotherapy from this phase I study.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • 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 Locations

  • Korea, Republic of
    • Gyunggi
      • Anyang, Gyunggi, Korea, Republic of
        • Hallym University Medical Center

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pathologically confirmed advanced, recurrent or metastatic adenocarcinoma of stomach (stage IV by primary tumor, regional nodes, metastasis(TNM) staging system)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • More than 3 months expected life span
  • Measurable lesion by RECIST criteria version 1.1
  • Palliative chemotherapy naive
  • Adequate organ functions
  • Participants must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital

Exclusion Criteria:

  • Positive Her2 status on participants' cancer tissue.
  • Any prior 2 years or concurrent malignancy other than non-melanoma skin cancer, in situ cancer of uterine cervix, or papillary or follicular thyroid cancer.
  • Participants who had received radiation therapy for target lesions 4 weeks before study enrollment
  • Participants who had received major surgery 4 weeks before study enrollment
  • Participants with active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, myocardial infarction during the preceding 12 months, pregnancy, or breast feeding
  • Participants with central nervous system(CNS) metastases
  • Participants with peripheral sensory neuropathies with impaired functional activities
  • Participants with gastrointestinal obstruction or bleeding inducing mal-absorption of oral chemotherapeutic agents.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oxaliplatin, Irinotecan, S-1(OIS)

triple combination with oxaliplatin, irinotecan, and S-1.

Treatment will be delivered as a 2-week cycle.

  1. Oxaliplatin 65 mg/m2 iv on day 1
  2. Irinotecan 135 mg/m2 iv on day 1
  3. S-1 80 mg/m2/day on day 1-7
Drug: Oxaliplatin, Irinotecan, S-1(OIS)

Treatment will be delivered every 2 weeks

  1. oxaliplatin 65 mg/m2 iv on day 1
  2. irinotecan 135 mg/m2 iv on day 1
  3. S-1 80 mg/m2/day po on day 1-7
Other Names:
  • Liplatin, Inotecan, TS-1 (tegafur, gimeracil, oteracil)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall response rate
Time Frame: 1.5 years
Tumor response will be classified on the basis of the response evaluation criteria in solid tumors (RECIST) guidelines version 1.1
1.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free survival
Time Frame: 1.5 years
The progression-free survival (PFS) will be measured from the start of study treatment until documented tumor progression (by RECIST) or death due to any cause
1.5 years
overall survival
Time Frame: 1.5 years
The overall survival (OS) will be estimated from the start of study treatment until participant's death and measured using the Kaplan-Meier method
1.5 years
Toxicity profiles - The number of participants and grade of intensity of treatment related adverse events
Time Frame: 1.5 years
adverse events will be graded using the NCI common terminology criteria for adverse events (NCTCAE) v 4.0
1.5 years

Collaborators and Investigators

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

Sponsor

Hallym University Medical Center

Collaborators

Jeil Pharmaceutical Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

August 14, 2015

First Submitted That Met QC Criteria

August 17, 2015

First Posted (Estimate)

August 19, 2015

Study Record Updates

Last Update Posted (Actual)

August 23, 2017

Last Update Submitted That Met QC Criteria

August 22, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMC-HO-GI-1401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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