search
Back to results

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

Primary Purpose

Stomach Neoplasm

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Oxaliplatin, Irinotecan, S-1(OIS)
Sponsored by
Hallym University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Neoplasm focused on measuring stomach neoplasm, oxaliplatin, irinotecan, S-1

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hallym university medical center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oxaliplatin, Irinotecan, S-1(OIS)

Arm Description

triple combination with oxaliplatin, irinotecan, and S-1. Treatment will be delivered as a 2-week cycle. Oxaliplatin 65 mg/m2 iv on day 1 Irinotecan 135 mg/m2 iv on day 1 S-1 80 mg/m2/day on day 1-7

Outcomes

Primary Outcome Measures

overall response rate
Tumor response will be classified on the basis of the response evaluation criteria in solid tumors (RECIST) guidelines version 1.1

Secondary Outcome Measures

progression free survival
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
overall survival
The overall survival (OS) will be estimated from the start of study treatment until participant's death and measured using the Kaplan-Meier method
Toxicity profiles - The number of participants and grade of intensity of treatment related adverse events
adverse events will be graded using the NCI common terminology criteria for adverse events (NCTCAE) v 4.0

Full Information

First Posted
August 14, 2015
Last Updated
August 22, 2017
Sponsor
Hallym University Medical Center
Collaborators
Jeil Pharmaceutical Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT02527785
Brief Title
Study of Oxaliplatin, Irinotecan, and S-1 in Gastric Cancer
Official Title
Phase II Study of S-1 in Combination With Oxaliplatin and Irinotecan in Patients With Advanced, Recurrent or Metastatic Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hallym University Medical Center
Collaborators
Jeil Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasm
Keywords
stomach neoplasm, oxaliplatin, irinotecan, S-1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxaliplatin, Irinotecan, S-1(OIS)
Arm Type
Experimental
Arm Description
triple combination with oxaliplatin, irinotecan, and S-1. Treatment will be delivered as a 2-week cycle. Oxaliplatin 65 mg/m2 iv on day 1 Irinotecan 135 mg/m2 iv on day 1 S-1 80 mg/m2/day on day 1-7
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin, Irinotecan, S-1(OIS)
Other Intervention Name(s)
Liplatin, Inotecan, TS-1 (tegafur, gimeracil, oteracil)
Intervention Description
Treatment will be delivered every 2 weeks oxaliplatin 65 mg/m2 iv on day 1 irinotecan 135 mg/m2 iv on day 1 S-1 80 mg/m2/day po on day 1-7
Primary Outcome Measure Information:
Title
overall response rate
Description
Tumor response will be classified on the basis of the response evaluation criteria in solid tumors (RECIST) guidelines version 1.1
Time Frame
1.5 years
Secondary Outcome Measure Information:
Title
progression free survival
Description
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
Time Frame
1.5 years
Title
overall survival
Description
The overall survival (OS) will be estimated from the start of study treatment until participant's death and measured using the Kaplan-Meier method
Time Frame
1.5 years
Title
Toxicity profiles - The number of participants and grade of intensity of treatment related adverse events
Description
adverse events will be graded using the NCI common terminology criteria for adverse events (NCTCAE) v 4.0
Time Frame
1.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dae Young Zang, MD, PhD
Organizational Affiliation
Hallym University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hallym university medical center
City
Anyang
State/Province
Gyunggi
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29372461
Citation
Kim HS, Ryu MH, Zang DY, Park SR, Han B, Kang WK, Rha SY, Jung M, Kim JS, Kang BW, Lee KH, Rho SY, Kim JH, Kim KC, Cho JW, Choi DR, Lim H, Kang HS, Soh JS, Kim MJ, Seo J, Kang YK. Phase II study of oxaliplatin, irinotecan and S-1 therapy in patients with advanced gastric cancer: the Korean Cancer Study Group ST14-11. Gastric Cancer. 2018 Sep;21(5):802-810. doi: 10.1007/s10120-018-0794-1. Epub 2018 Jan 25.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs