FOLFIRI Versus Docetaxel and Cisplatin as a Second-line Chemotherapy After Failure of First-line Chemotherapy in Advanced Gastric Cancer

Study Overview
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Brief Summary
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Patients diagnosis with inoperable gastric cancers are treated with palliative chemotherapy. Palliative chemotherapy had proven to be better overall survivals and quality of life in unresectable advanced gastric cancer. NCCN guideline suggested two or three drug cytotoxic regimen as a first line therapy. But response rate of those regimens is about 50 percent. Disappointingly most of cases are about to experience progression of disease. Second line regimens of palliative chemotherapy are also have shown its efficacy and recommended within patients with better performance status. But There is still lack of evidences in gastric cancer patients second line chemotherapy. Several phase II trial those subjects are 2nd line palliative chemotherapy in gastric cancer had suggested that irinotecan, taxane, oxaliplatin, oral fluorouracil.Investigator assessed whether cisplatin in combination with paclitaxel would increase response rate in patient previously treated for advanced gastric cancer compared with FOFIRI regimen.

Conditions
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Inoperable Gastric Cancer

Intervention / Treatment
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* Drug: 5-fluorouracil, irinotecan and leucovorin
* Drug: docetaxel and cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Older than 19 years old and younger than 75 years old Pathologically confirmed gastric cancer Inoperable stage at diagnosis experienced diseases progression in first line palliative chemotherapy ECOG performance status 0 or 1 Adequate renal function (serum creatinine < 1.5 mg/dL or calculated creatinine clearance ≥ 60 ml/min) Adequate liver function (total bilirubin < 1.5 X the upper limits of normal (ULN), AST and ALT <3 X UNL, and alkaline phosphatases < 3 X ULN or < 5 x ULN in case of liver involvement) Adequate BM function (WBC ≥ 3,500/µl, absolute neutrophil cell count ≥ 1,500 /µl, platelet count ≥ 100,000/µl) Subjects who given written informed consent after being given a full description of the study Exclusion Criteria: double primary cancer other than gastric cancer history of palliative radiation therapy Pregnant or on breast feeding Neuropathy grade > 3 Active infection Symptomatic cardiopulmonary diseases Active hepatitis of liver cirrhosis Impaired renal function Impaired psychologic bone marrow function Psychologic disorder, Severe neurologic disorder. hypersensitivity to chemotherapeutic agent

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FOLFIRI<br>2nd palliative chemotherapy with FOLFIRI regimen,In FOLFIRI group, patients received irinotecan 180 mg/m2 and 5- fluorouracil 400mg/m2 intravenously bolus injection on days 1 and leucovorin 200mg/m2 for 2 hours and 5-fluorouracil 600mg/m2 for 22 hours intravenously infusion on day 2 of a 14-day cycle. Response evaluation would be done after 3 cycle of chemotherapy in DP group | Drug: 5-fluorouracil, irinotecan and leucovorin<br>* In FOLFIRI group, patients received irinotecan 180 mg/m2 and 5-fluorouracil 400mg/m2 intravenously bolus injection on days 1 and leucovorin 200mg/m2 for 2 hours and 5-fluorouracil 600mg/m2 for 22 hours intravenously infusion on day 2 of a 14-day cycle.<br>|
| Active Comparator: DP<br>2nd palliative chemotherapy with Docetaxel/cisplatin regimen, In DP group, patients received docetaxel 75 mg/m2 and cisplatin 75mg/m2 intravenously on days 1 of a 21-day cycle. Response evaluation would be done after 2 cycle of chemotherapy in DP group | Drug: docetaxel and cisplatin<br>* In DP group, patients received docetaxel 75 mg/m2 and cisplatin 75mg/m2 intravenously on days 1 of a 21-day cycle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate | CT examination would be done at 7 8 weeks after initiation of 1st cycle chemotherapeutic agent, After 2 cycle of chemotherapy in DP group and 3cyle of chemotherapy in FOFIRI group. | up to 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diseases control rate | disease control, defined as the proportion of patients who had a best response of complete response, partial response, or stable | up to 2 year | 
| Overall survival | overall survival, defined as time from randomisation to death | up to 2 year | 
| progression free survival | progression-free survival, defined as time from randomisation to radiographic progression or death | up to 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inoperable gastric cancer, palliative chemotherapy