Low-Tox Vs Eox In Patients With Locally Advanced Unresectable Or Metastatic Gastric Cancer

• Status: Terminated
• Trial end date: 2018-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
• Collaborator: Regione Lombardia
• Treatments: Capecitabine; Docetaxel; Epirubicin; Oxaliplatin

Criteria

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
• AST and ALT
• Alkaline phosphatase (ALP)2.5x ULN and AST and ALT
• 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)