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
|Condition or disease||Intervention/treatment||Phase|
|Stomach Neoplasm||Drug: Oxaliplatin, Irinotecan, S-1(OIS)||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Oxaliplatin, Irinotecan, S-1(OIS)
triple combination with oxaliplatin, irinotecan, and S-1.
Treatment will be delivered as a 2-week cycle.
Drug: Oxaliplatin, Irinotecan, S-1(OIS)
Treatment will be delivered every 2 weeks
Other Name: Liplatin, Inotecan, TS-1 (tegafur, gimeracil, oteracil)
- 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
- 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
- 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
- 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
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
|Korea, Republic of|
|Hallym university medical center|
|Anyang, Gyunggi, Korea, Republic of|
|Principal Investigator:||Dae Young Zang, MD, PhD||Hallym University Medical Center|