Oxaliplatin in Esophagus Cancer (Advanced) 1st Line | NCT00259402

Studies
Oxaliplatin in Esophagus Cancer (Advanced) 1st Line

NCT00259402

Sponsor

Sanofi

Status

Completed

Last Update Posted

Dec 7, 2009Estimated

Enrollment

41Actual

Phase

Phase 2

Conditions

Esophageal Neoplasms

Interventions

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

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2000

Primary Completion Date

Oct 2008Actual

Completion Date

Oct 2008Actual

First Submitted Date

Nov 28, 2005

First Submission Date that Met QC Criteria

Nov 28, 2005

First Posted Date

Nov 29, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2009

Last Update Posted Date

Dec 7, 2009Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

41Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oxaliplatin	Experimental		Drug: Oxaliplatin + cisplatin + 5-Fluorouracil (5-FU)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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	Oxaliplatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy endpoints include tumor response, progression free and overall survival.		Throughout the whole study

Secondary Outcomes

Measure	Description	Time Frame
Safety endpoints include summary of adverse events assessed by history, physical exams and laboratory evaluations.		Throughout the whole study duration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
José Mª Taboada	Sanofi	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-Aventis Administrative Office		Barcelona			Spain

Condition Browse Module

MeSH Terms

ID	Term
D004938	Esophageal Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077150	Oxaliplatin
D002945	Cisplatin
D005472	Fluorouracil

Ancestor Terms

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals
D017606	Chlorine Compounds
D007287	Inorganic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided