Comparison between the combination Low-Docetaxel, Oxaliplatin, Capecitabine (Low-Tox) Vs Epirubicin, Oxaliplatin and Capecitabine (Eox) in patients with stomach tumor

Phase 1

• Conditions: ocally advanced unresectable or metastatic gastric cancer.; MedDRA version: 14.1Level: LLTClassification code 10007350Term: Carcinoma gastricSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-005537-39-IT
• Lead Sponsor: GISCAD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-23
• Study Completion: 2018-12-31
• Last Update Posted: 23 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 169

Inclusion Criteria

1. Signed written informed consent prior to beginning protocol specific procedures. 2. Male or female <70 years of age. 3. Histologically proven diagnosis of adenocarcinoma of the stomach. 4. HER2 negative tumor or HER2+ tumors not qualifying for herceptin therapy. 5. Locally advanced (non resectable) or metastatic gastric cancer. 6. 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). 7. Life expectancy of >/= 3 months. 8. ECOG performance status of 0-1 at study entry. 9. Neutrophils >/= 2.0 x 1000000000/L, platelets >/= 100 x 1000000000/L, and hemoglobin >/= 10 g/dL. 10. Bilirubin level either normal or 2.5x ULN and AST and ALT /= 60 mL/min. 14. Negative pregnancy test (if female in reproductive years). 15. Effective contraception prior to study entry and for the duration of the study participation, for both male and female patients of child producing potential. 16. Able and willing to comply with scheduled visits, therapy plans and laboratory tests required in this protocol.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 362
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

1. Previous chemotherapy, except adjuvant treatment administered at least 1 year before study entry. 2. Concurrent chronic systemic immune therapy. 3. Any investigational agent(s) 4 weeks prior to entry. 4. 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. 5. Known hypersensitivity to study drugs. Known grade 3 or 4 allergic reaction to any of the components of the treatment. 6. Known drug abuse/ alcohol abuse. 7. Acute or subacute intestinal occlusion and any other significant chronic gastrointestinal disease that might interfere with absorption of oral treatment. 8. History of clinically relevant psychiatric disability precluding informed consent. 9. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. 10. Pregnant or breastfeeding women. 11. Active uncontrolled infection(s). 12. Positive for HIV serology and/or viral hepatitis B or C. 13. 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the therapeutic efficacy of Docetaxel, Oxaliplatin and Capecitabine (low-TOX) vs. Epirubicin, Oxaliplatin and Capecitabine (EOX) as measured by the duration of overall survival (OS) in patient with locally advanced/metastatic gastric cancer.;Secondary Objective: To evaluate additional measures of tumor control to further characterize the efficacy of the low-TOX regimen vs. EOX regimen. Evaluation of the safety profile of the 2 combinations tested.;Primary end point(s): Overall Survival (OS), defined for each patient as the time from randomization to the date of death from any cause.;Timepoint(s) of evaluation of this end point: At patient's death.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Progression Free Survival (PFS), defined as the time from randomization to the date of local or regional progression, distant metastasis, second primary malignancy or death from any cause, whichever comes first. 2. Objective Response Rate (CR + PR) according to RECIST 1.1 guideline. 3. Disease control rate: CR + PR + SD lasting > 12 weeks. 4. Tolerability of the treatments evaluated in term of occurrence of: side effects graded according to the NCI-CTCAE scale (version 4.0); serious adverse reactions, expected and unexpected.;Timepoint(s) of evaluation of this end point: 1. At the date of progression, second primary malignancy or death. 2, 3, 4. All study period, including follow up.