Low-Tox Vs Eox In Patients With Locally Advanced Unresectable Or Metastatic Gastric Cancer
A Randomized Phase III Study Of Low-Docetaxel Oxaliplatin, Capecitabine (Low-Tox) Vs Epirubicin, Oxaliplatin And Capecitabine (Eox) In Patients With Locally Advanced Unresectable Or Metastatic Gastric Cancer
  • Phase

    Phase 3
  • Study Type

  • Status

  • Study Participants

This is a randomized, parallel group, non-blinded phase III trial. Patients with advanced (locoregional or metastatic) gastric cancer not previously treated with chemotherapy for this stage will be randomized in a 1:1 ratio to receive low-TOX (arm A) or EOX (arm B). Randomization will be stratified by performance status (ECOG 0, 1 and 2).
Although the incidence of the adenocarcinoma of the stomach is slowly decreasing, gastric cancer represents the second worldwide cause of cancer death after lung cancer. In patients with advanced disease, chemotherapy improves survival and quality of life. Combinations of two or three drugs including a platin derivative (cisplatin or oxaliplatin), a fluoropyrimidine (5FU or capecitabine) and an anthracycline (usually epirubicin) have demonstrated superiority compared to single or double agent therapy and are the current standard. As of today there are no published studies comparing anthracycline-based to taxane-based three-drug regimens. The objective of the present study is to compare EOX as evaluated in REAL-2 to the low-TOX regimen consisting of docetaxel, oxaliplatin and capecitabine. Low-TOX is expected to be better tolerated than the original DCF regimen. The study will be performed in the HER2 negative patients.
Study Started
Jan 31
Primary Completion
Dec 31
Study Completion
Dec 31
Last Update
Oct 09

Drug Docetaxel

Powder for solution for infusion

  • Other names: Taxotere 20 mg/mL

Drug Epirubicin

Solution for infusion

  • Other names: Farmorubicina 2mg/mL

Drug Oxaliplatin

Powder for solution for infusion

  • Other names: Eloxatin 5 mg/mL

Drug Capecitabine

Film coated tablets

  • Other names: Xeloda 150 mg, Xeloda 500 mg

Docetaxel & Oxaliplatin & Capecitabine Experimental

Patients will receive cycles every 3 weeks of Docetaxel (35 mg/ m2, intravenous at days 1 and 8 by 1-hour infusion)and Oxaliplatin (80 mg/ m2, intravenous at day 1 by 2-hour infusion) and Capecitabine (750 mg/ m2, oral tablets of 500 and 150 mg, x2 daily for 2 weeks)

Epirubicin & Oxaliplatin & Capecitabine Experimental

Patients will receive cycles every 3 weeks of Epirubicin (50 mg/ m2, intravenous on day 1 by 2-hour infusion)and Oxaliplatin (130 mg/ m2, intravenous on day 1 by 2-hour infusion) and Capecitabine (625 mg/ m2,oral tablets of 500 and 150 mg, x2 daily for 3 weeks)


Inclusion Criteria:

Signed written informed consent prior to beginning protocol specific procedures
Male or female > 18 years of age
Histologically proven diagnosis of adenocarcinoma of the stomach
HER2 negative tumor or HER2+ tumors not qualifying for herceptin therapy
Locally advanced (non resectable) or metastatic gastric cancer
Presence of measurable disease with at least one measurable lesion by means of CT scan or MRI in not previously irradiated area(s) (according to RECIST criteria (version 1.1)
Life expectancy of >/= 3 months
ECOG performance status of 0-2 at study entry
Neutrophils >/= 2.0 x 1000000000/L, platelets >/= 100 x 1000000000/L, and hemoglobin >/= 10 g/dL
Bilirubin level either normal or </= 1.5 x ULN
AST and ALT </= 2.5 X UNL (</= 5 x ULN if liver metastasis are present
Alkaline phosphatase (ALP) </= 2.5 X ULN; patients with alkaline phosphatase > 2.5x ULN and AST and ALT </= 1.5 x ULN are equally eligible
Serum creatinine < 1.5 x ULN. In presence border-line values, the calculated creatinine clearance should be >/= 60 mL/min
Negative pregnancy test (if female in reproductive years)
Effective contraception prior to study entry and for the duration of the study participation, for both male and female patients of child producing potential
Able and willing to comply with scheduled visits, therapy plans and laboratory tests required in this protocol

Exclusion Criteria:

Previous chemotherapy, except adjuvant treatment administered at least 1 year before study entry
Concurrent chronic systemic immune therapy
Any investigational agent(s) 4 weeks prior to entry
Clinically relevant coronary artery disease or a history of a myocardial infarction or a history of hypertension not controlled by therapy within the last 12 months
Known hypersensitivity to study drugs. Known grade 3 or 4 allergic reaction to any of the components of the treatment
Known drug abuse/ alcohol abuse
Acute or subacute intestinal occlusion and any other significant chronic gastrointestinal disease that might interfere with absorption of oral treatment
History of clinically relevant psychiatric disability precluding informed consent
Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Pregnant or breastfeeding women
Active uncontrolled infection(s)
Positive for HIV serology and/or viral hepatitis B or C
Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for ≥ 5 years will be allowed to enter the trial)
No Results Posted