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

NCT ID: NCT02445209

Last Updated: 2015-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2014-02-28

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)

Conditions

HER2 Negative Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EOX

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.

Group Type: ACTIVE_COMPARATOR

EOX

Intervention Type: OTHER

combined chemotherapy regimen: epirubicin + oxaliplatin + capecitabine

mDCF

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

Group Type: ACTIVE_COMPARATOR

mDCF

Intervention Type: OTHER

combined chemotherapy regimen: docetaxel + leucovorin + 5fluorouracil + cisplatin

Interventions

EOX

combined chemotherapy regimen: epirubicin + oxaliplatin + capecitabine

Intervention Type: OTHER

mDCF

combined chemotherapy regimen: docetaxel + leucovorin + 5fluorouracil + cisplatin

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jagiellonian University

OTHER

Sponsor Role: lead

Responsible Party

Sebastian Ochenduszko

Sebastian Ochenduszko, MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sebastian Ochenduszko, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

Jagiellonian University

References

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.

Reference Type: BACKGROUND

PMID: 18172173 (View on PubMed)

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.

Reference Type: BACKGROUND

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.

Reference Type: DERIVED

PMID: 26354521 (View on PubMed)

Other Identifiers

JagiellonianU-01

Identifier Type: -

Identifier Source: org_study_id