Clinical trial · Interventional
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
NCT02076594CI-TRIAL-00041068terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The interim analysis performed on 09 November 2018, showed the failure to achieve the primary objective of effectiveness of the experimental treatment.
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Unresectable Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Epirubicin | Drug | Epirubicin | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Docetaxel & Oxaliplatin & Capecitabine
- description
- 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)
- interventionNames
- Drug: Docetaxel
- Drug: Oxaliplatin
- Drug: Capecitabine
- type
- EXPERIMENTAL
- label
- Epirubicin & Oxaliplatin & Capecitabine
- description
- 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)
- interventionNames
- Drug: Epirubicin
- Drug: Oxaliplatin
- Drug: Capecitabine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.