Back to resultsComparison of Efficacy and Frequency of Adverse Events of 1st Line Palliative Chemotherapy EOX and mDCF Regimens in Advanced HER2-negative Gastric Carcinoma
Primary Purpose
HER2 Negative Gastric Cancer
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
EOX
mDCF
Sponsored by
About this trial
This is an interventional treatment trial for HER2 Negative Gastric Cancer focused on measuring HER2-negative gastric and GEJ adenocarcinoma, first-line palliative chemotherapy, EOX, mDCF, efficacy, safety
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
EOX
mDCF
Arm 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.
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
Outcomes
Primary Outcome Measures
Overall Survival
time from randomization until death from any cause
Secondary Outcome Measures
Progression-free Survival
time from randomization to disease progression or death from any cause
Safety as assessed by adverse events according to CTCAE v4.0
occurrence of adverse events according to CTCAE v4.0
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02445209
Brief Title
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
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jagiellonian University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HER2 Negative Gastric Cancer
Keywords
HER2-negative gastric and GEJ adenocarcinoma, first-line palliative chemotherapy, EOX, mDCF, efficacy, safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EOX
Arm Type
Active Comparator
Arm 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.
Arm Title
mDCF
Arm Type
Active Comparator
Arm 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
Intervention Type
Other
Intervention Name(s)
EOX
Intervention Description
combined chemotherapy regimen: epirubicin + oxaliplatin + capecitabine
Intervention Type
Other
Intervention Name(s)
mDCF
Intervention Description
combined chemotherapy regimen: docetaxel + leucovorin + 5fluorouracil + cisplatin
Primary Outcome Measure Information:
Title
Overall Survival
Description
time from randomization until death from any cause
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Progression-free Survival
Description
time from randomization to disease progression or death from any cause
Time Frame
3 years
Title
Safety as assessed by adverse events according to CTCAE v4.0
Description
occurrence of adverse events according to CTCAE v4.0
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian Ochenduszko, M.D., PhD
Organizational Affiliation
Jagiellonian University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
18172173
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
26354521
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.
Results Reference
derived
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Comparison of Efficacy and Frequency of Adverse Events of 1st Line Palliative Chemotherapy EOX and mDCF Regimens in Advanced HER2-negative Gastric Carcinoma
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