Comparison of Efficacy and Frequency of Adverse Events of 1st Line Palliative Chemotherapy EOX and mDCF Regimens in Advanced HER2-negative Gastric Carcinoma
HER2 Negative Gastric Cancer
About this trial
This is an interventional treatment trial for HER2 Negative Gastric Cancer focused on measuring HER2-negative gastric and GEJ adenocarcinoma, first-line palliative chemotherapy, EOX, mDCF, efficacy, safety
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
EOX
mDCF
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.
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