Clinical trial · Interventional
Oxaliplatin in Gastric Cancer
Oxaliplatin Phase II Trial in Association With 5FU and Folinic Acid in the Treatment of Advanced Unresectable or Metastatic Gastric Cancer.
NCT00263354CI-TRIAL-00004092completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To determine the objective response to oxaliplatin/5FU/leucovorin combination chemotherapy in patients with advanced unresectable or metastatic gastric cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- To evaluate response rate according to RECIST criteria
- measure
- To evaluate the progression-free survival in the ITT population
Secondary outcomes (2)
- measure
- To evaluate the overall survival in the ITT population
- measure
- To investigate safety using NCI-CTC criteria version 2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ECOG performance status of 0-2. * Histologically proven gastric or gastro-esophageal junction adenocarcinoma. * At least unidimensional measurable disease. If a unique metastasis constitutes the only disease sign, it requires histological confirmation. * First line locally unresectable or metastatic gastric cancer. * Relapsing gastric cancer after local and/or systemic treatment with a post-surgical period of at least 4 weeks, a post-adjuvant or neoadjuvant chemoradiotherapy period of at least 6 months. * Serum bilirubin \< 2 mg/dl * Serum creatinine \< or = 2 mg/dl * Hemoglobin \> or = 10 g/dl * Absolute neutrophil count \> or = 2000/dl * Platelet count \>or = 100, 000/dl * AST/ALT \< or = 2.5 time-fold the institutional normal upper limit * Alkaline phosphatase \< or = 5 time-fold the institutional normal upper limit * Imagenological evaluation of the patient at least 2 weeks prior to the drug infusion * Laboratory tests at least 1 week prior to the first infusion * Patient available for follow up and able to answer to the quality of life questionnaire Exclusion Criteria: * Symptomatic sensorial peripheral neuropathy * Uncontrolled concomitant disease * Another malignant neoplastic disease diagnosed within the previous 5 years to the diagnosis of advanced or metastatic gastric cancer, with the exception of 'in situ' cervix carcinoma or non-melanoma skin cancer * Concomitant antitumoral treatment * Cerebral metastases * Unstable heart disease, even though in treatment * Myocardial infarction within the last 6 months * Radiotherapy within the last 6 weeks, surgery within the last 4 weeks, or chemotherapy within the last 6 months. * Pregnancy or nursing ( or women in reproductive life without adequate contraception) * Significant neurological or psychiatric disorders.
References
Publications (0)
Data not yet available
No reference posted for this study.