Oxaliplatin in Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
To determine the objective response to oxaliplatin/5FU/leucovorin combination chemotherapy in patients with advanced unresectable or metastatic gastric cancer.

Official Title
-----------------
Oxaliplatin Phase II Trial in Association With 5FU and Folinic Acid in the Treatment of Advanced Unresectable or Metastatic Gastric Cancer.

Conditions
-----------------
Stomach Neoplasms

Intervention / Treatment
-----------------
* Drug: Oxaliplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Oxaliplatin|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate response rate according to RECIST criteria |  |  | 
| To evaluate the progression-free survival in the ITT population |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the overall survival in the ITT population |  |  | 
| To investigate safety using NCI-CTC criteria version 2 |  |  |