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

Phase 2

Completed

• Conditions: Stomach Neoplasm
• Interventions: Drug: Oxaliplatin, Irinotecan, S-1(OIS)

• Registration Number: NCT02527785
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-08-14
• Study First Submitted QC: 2015-08-17
• Study First Posted: 2015-08-19
• Primary Completion: 2016-06
• Study Completion: 2017-04
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-22
• Last Update Posted: 2017-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oxaliplatin, Irinotecan, S-1(OIS)	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

Primary Outcome Measures

Name	Time	Method
overall response rate	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

Name	Time	Method
progression free survival	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
overall survival	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
Toxicity profiles - The number of participants and grade of intensity of treatment related adverse events	1.5 years	adverse events will be graded using the NCI common terminology criteria for adverse events (NCTCAE) v 4.0

Trial Locations

Locations (1)

Hallym university medical center; 🇰🇷 Anyang, Gyunggi, Korea, Republic of