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

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ClinicalTrials.gov Identifier: NCT02527785
Recruitment Status : Completed
First Posted : August 19, 2015
Last Update Posted : August 23, 2017
Sponsor:
Collaborator:
Jeil Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Hallym University Medical Center

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.

Condition or disease Intervention/treatment Phase
Stomach Neoplasm Drug: Oxaliplatin, Irinotecan, S-1(OIS) Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of S-1 in Combination With Oxaliplatin and Irinotecan in Patients With Advanced, Recurrent or Metastatic Gastric Cancer
Study Start Date : February 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

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 Name: Liplatin, Inotecan, TS-1 (tegafur, gimeracil, oteracil)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT02527785


Locations
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Korea, Republic of
Hallym university medical center
Anyang, Gyunggi, Korea, Republic of
Sponsors and Collaborators
Hallym University Medical Center
Jeil Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Dae Young Zang, MD, PhD Hallym University Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hallym University Medical Center
ClinicalTrials.gov Identifier: NCT02527785     History of Changes
Other Study ID Numbers: HMC-HO-GI-1401
First Posted: August 19, 2015    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Hallym University Medical Center:
stomach neoplasm
oxaliplatin
irinotecan
S-1
Additional relevant MeSH terms:
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Oxaliplatin
Stomach Neoplasms
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Irinotecan
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action