Clinical trial NCT02527785: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stomach Neoplasm
Keywords: stomach neoplasm
oxaliplatin
irinotecan
S-1
Lead sponsor: Hallym University Medical Center
Sponsor class: OTHER
Collaborators: name: Jeil Pharmaceutical Co., Ltd.
First posted: 2015-08-19
Enrollment: 44
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: overall response rate
timeFrame: 1.5 years
Secondary outcomes:
measure: progression free survival
timeFrame: 1.5 years
measure: overall survival
timeFrame: 1.5 years
measure: Toxicity profiles - The number of participants and grade of intensity of treatment related adverse events
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Hallym university medical center
state: Gyunggi
Study officials:
affiliation: Hallym University Medical Center
name: Dae Young Zang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.