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

Jagiellonian University

Status and phase: Completed; Phase 3

Conditions: HER2 Negative Gastric Cancer

Treatments: Other: EOX; Other: mDCF

Study type: Interventional

Funder types: Other

Identifiers

NCT02445209

JagiellonianU-01

Details and patient eligibility

About

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

Full 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)

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

EOX

Active Comparator group

Description:

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.

Treatment:

Other: EOX

mDCF

Active Comparator group

Description:

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

Treatment:

Other: mDCF