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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
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EOX | Active Comparator | 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. |
|
| mDCF | Active Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EOX | Other | combined chemotherapy regimen: epirubicin + oxaliplatin + capecitabine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | time from randomization until death from any cause | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | time from randomization to disease progression or death from any cause | 3 years |
| Safety as assessed by adverse events according to CTCAE v4.0 | occurrence of adverse events according to CTCAE v4.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sebastian Ochenduszko, M.D., PhD | Jagiellonian University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18172173 | Background | 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. | |
| Background | 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. | ||
| 26354521 |
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| mDCF |
| Other |
combined chemotherapy regimen: docetaxel + leucovorin + 5fluorouracil + cisplatin |
|
| 3 years |
| Derived |
| 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. |