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

Last updated: May 14, 2015
Sponsor: Jagiellonian University
Overall Status: Completed

Phase

3

Condition

Stomach Cancer

Gastric Cancer

Digestive System Neoplasms

Treatment

N/A

Clinical Study ID

NCT02445209
JagiellonianU-01
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients ≥ 18 years

  • histologically confirmed inoperable locally advanced, recurrent, or metastaticadenocarcinoma 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 inSolid Tumors (RECIST). Patients with intraoperatively confirmed intraperitonealmetastases but without detectable disease in radiological studies were also eligible

Exclusion

Exclusion Criteria:

  • HER2- positive tumors defined as either IHC 3+ or IHC 2+, the latter in combinationwith 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 highlikelihood of being cured (e.g. basal cell carcinoma of the skin, cervical cancer)

  • clinical evidence of brain metastases

Study Design

Total Participants: 56
Study Start date:
September 01, 2010
Estimated Completion Date:
February 28, 2014

Study 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)