Comparison of Efficacy and Frequency of Adverse Events of 1st Line Palliative Chemotherapy EOX and mDCF Regimens in Advanced HER2-negative Gastric Carcinoma

Study Overview
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Brief Summary
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The purpose of the study is to compare efficacy and safety of palliative chemotherapy EOX and mDCF regimens in the first-line treatment of patients with advanced HER2-negative gastric and gastroesophageal junction (GEJ) adenocarcinoma

Detailed Description
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The main purposes: to determine the overall survival (OS) of patients who have locally advanced inoperable or metastatic HER2-negative gastric and gastroesophageal adenocarcinoma treated with first-line EOX (epirubicin + oxaliplatin + capecitabine) or mDCF (docetaxel + cisplatin + leucovorin + 5fluorouracil) palliative chemotherapy regimens The secondary purposes: to determine safety (as assessed by adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.0) and the progression-free survival (PFS)

Conditions
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HER2 Negative Gastric Cancer

Intervention / Treatment
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* Other: EOX
* Other: mDCF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥ 18 years histologically confirmed inoperable locally advanced, recurrent, or metastatic adenocarcinoma of the stomach or gastro-oesophageal junction; ECOG (Eastern Cooperative Oncology Group) performance status 0-2; adequate renal, hepatic, and hematologic function; measurable or nonmeasurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST). Patients with intraoperatively confirmed intraperitoneal metastases but without detectable disease in radiological studies were also eligible Exclusion Criteria: HER2- positive tumors defined as either IHC 3+ or IHC 2+, the latter in combination with FISH+ previous chemotherapy for metastatic or locally advanced disease surgery <3 weeks before the onset of the study treatment congestive heart failure significant dysphagia that would preclude oral administration of capecitabine concurrent malignant disease, except for adequately treated tumors with high likelihood of being cured (e.g. basal cell carcinoma of the skin, cervical cancer) clinical evidence of brain metastases

Ages Eligible for Study
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Minimum Age: 18 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EOX<br>Epirubicin 50mg/m2 IV on day 1; Oxaliplatin 130mg/m2 IV on day 1; Capecitabine 625mg/m2/day PO BID days 1-21; Cycled every 21 days. Cycled every 3 weeks for a maximum of 8 cycles initially (24 weeks of treatment). Patients who experienced a long term response to the initial 8 cycles of EOX chemotherapy, could be rechallenged with the same regimen. | Other: EOX<br>* combined chemotherapy regimen: epirubicin + oxaliplatin + capecitabine<br>|
| Active Comparator: mDCF<br>Docetaxel 40 mg/m2 IV od day 1; Leucovorin 400 mg/m2 IV on day 1; 5fluorouracyl 400 mg/m2 IV on day 1; 5fluorouracil 1000 mg/m2/d IV continuous infusion days 1-2; Cisplatin 40 mg/m2 IV on day 3; Cycled every 2 weeks for a maximum of 12 cycles initially (24 weeks of treatment). Patients who experienced a long term response to the initial 12 cycles of mDCF chemotherapy, could be rechallenged with the same regimen | Other: mDCF<br>* combined chemotherapy regimen: docetaxel + leucovorin + 5fluorouracil + cisplatin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | time from randomization until death from any cause | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival | time from randomization to disease progression or death from any cause | 3 years | 
| Safety as assessed by adverse events according to CTCAE v4.0 | occurrence of adverse events according to CTCAE v4.0 | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EOX, HER2-negative gastric and GEJ adenocarcinoma, first-line palliative chemotherapy, mDCF, efficacy, safety