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Oxaliplatin in Esophagus Cancer (Advanced) 1st Line

NCT ID: NCT00259402

Last Updated: 2009-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-02-29

Study Completion Date

2008-10-31

Brief Summary

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* 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

Detailed Description

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Conditions

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Esophageal Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oxaliplatin

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Interventions

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Oxaliplatin + 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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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sanofi-aventis

Principal Investigators

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José Mª Taboada

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis Administrative Office

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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EFC_7127

Identifier Type: -

Identifier Source: org_study_id