Clinical trial NCT02445209: Comparison of Efficacy and Frequency of Adverse Events of 1st Line Palliative Chemotherapy EOX and mDCF Regimens in Advanced HER2-negative Gastric Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HER2 Negative Gastric Cancer
Keywords: HER2-negative gastric and GEJ adenocarcinoma
first-line palliative chemotherapy
EOX
mDCF
efficacy
safety
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2015-05-15
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: Overall Survival
timeFrame: 3 years
Secondary outcomes:
measure: Progression-free Survival
timeFrame: 3 years
measure: Safety as assessed by adverse events according to CTCAE v4.0
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Jagiellonian University
name: Sebastian Ochenduszko, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cunningham D, Starling N, Rao S, Iveson T, Nicolson M, Coxon F, Middleton G, Daniel F, Oates J, Norman AR; Upper Gastrointestinal Clinical Studies Group of the National Cancer Research Institute of the United Kingdom. Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med. 2008 Jan 3;358(1):36-46. doi: 10.1056/NEJMoa073149.
citation: Shah MA, Stoller R, Shibata S, et al. Random assignment multicenter phase II study of modified docetaxel, cisplatin, fluorouracil (mDCF) versus DCF with growth factor support (GCSF) in metastatic gastroesophageal adenocarcinoma (GE). 2010 Gastrointestinal Cancers Symposium.
citation: Ochenduszko S, Puskulluoglu M, Konopka K, Fijorek K, Urbanczyk K, Budzynski A, Matlok M, Lazar A, Sinczak-Kuta A, Pedziwiatr M, Krzemieniecki K. Comparison of efficacy and safety of first-line palliative chemotherapy with EOX and mDCF regimens in patients with locally advanced inoperable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma: a randomized phase 3 trial. Med Oncol. 2015 Oct;32(10):242. doi: 10.1007/s12032-015-0687-7. Epub 2015 Sep 9.