Esophageal Neoplasms
Conditions
Brief summary
* 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
Interventions
DRUGOxaliplatin + cisplatin + 5-Fluorouracil (5-FU)
OXALIPLATIN 60 mg/m2/d, CISPLATIN 55 mg/m2/d, 5-FU 600 mg/m2/d with dose range and followed by radiotherapy
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy endpoints include tumor response, progression free and overall survival. | Throughout the whole study |
Secondary
| Measure | Time frame |
|---|---|
| Safety endpoints include summary of adverse events assessed by history, physical exams and laboratory evaluations. | Throughout the whole study duration |
Countries
Spain
Outcome results
None listed