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OpenTrials
Completed

NCT Number: NCT00259402

Oxaliplatin in Esophagus Cancer (Advanced) 1st Line

* 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

Completed

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Key information

Conditions

Esophageal Neoplasms Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sanofi-Aventis Administrative Office

Barcelona, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

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

    Time frame: Throughout the whole study

Secondary outcomes

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

    Time frame: Throughout the whole study duration

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Phase II Open-label Single Arm Study of Oxaliplatin Combined With Cisplatin and 5FU in Advanced Esophagus Cancer Patients

Important dates

Study start
2000
Primary completion
2008
Study completion
2008
First posted
Nov 29, 2005
Registry last updated
Dec 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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