HER2 Negative Gastric Cancer
Conditions
Keywords
HER2-negative gastric and GEJ adenocarcinoma, first-line palliative chemotherapy, EOX, mDCF, efficacy, safety
Brief summary
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
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)
Interventions
OTHEREOX
combined chemotherapy regimen: epirubicin + oxaliplatin + capecitabine
OTHERmDCF
combined chemotherapy regimen: docetaxel + leucovorin + 5fluorouracil + cisplatin
Sponsors
Jagiellonian University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 3 years | time from randomization until death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety as assessed by adverse events according to CTCAE v4.0 | 3 years | occurrence of adverse events according to CTCAE v4.0 |
| Progression-free Survival | 3 years | time from randomization to disease progression or death from any cause |
Outcome results
None listed