Oxaliplatin in Esophagus Cancer (Advanced) 1st Line

Sanofi41 enrolled

Overview

* To determine the activity and efficacy of the schema specified as dose regimen * To determine the safety and tolerability of the oxaliplatin-cisplatin and 5FU

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Esophageal Neoplasms

Interventions

Oxaliplatin + cisplatin + 5-Fluorouracil (5-FU)DRUG

OXALIPLATIN 60 mg/m2/d, CISPLATIN 55 mg/m2/d, 5-FU 600 mg/m2/d with dose range and followed by radiotherapy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * ECOG 0-1 * Patients with histologically proven epidermoid carcinoma or adenocarcinoma of esophagus or stomach, with unresectable or metastatic disease; * No previous treatment with chemotherapy or radiotherapy * Measurable lesion (uni or bidimensional) Exclusion Criteria: * Creatinin clearance \<50 mL/min * Total bilirubin \>1.5\*ULN (Upper Limit of Normal) * AST/ALT \> 2.5\*ULN * Total White Blood Cell \<1.500.000/mL * Platelet count \<100.000.000/mL * symptomatic sensitive peripheral neuropathy * pregnant or breast-feeding women The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (1)

Sanofi-Aventis Administrative Office

Barcelona, Spain

Outcomes

Primary Outcomes

Efficacy endpoints include tumor response, progression free and overall survival.

Time frame: Throughout the whole study

Secondary Outcomes

Safety endpoints include summary of adverse events assessed by history, physical exams and laboratory evaluations.

Time frame: Throughout the whole study duration

Data from ClinicalTrials.gov

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