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

NCT ID: NCT02527785

Last Updated: 2017-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-04-30

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.

Conditions

Stomach Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Oxaliplatin, Irinotecan, S-1(OIS)

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

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

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jeil Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Hallym University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dae Young Zang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hallym University Medical Center

Locations

Hallym university medical center

Anyang, Gyunggi, South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 29372461 (View on PubMed)

Other Identifiers

HMC-HO-GI-1401

Identifier Type: -

Identifier Source: org_study_id