Isolated Pelvic and Limb Perfusion in the Treatment of Lo... | NCT00181025

Studies
Isolated Pelvic and Limb Perfusion in the Treatment of Locally Advanced Sarcoma of Pelvis and Limbs' Girdle

NCT00181025

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Status

Unknown status

Last Update Posted

Jun 12, 2007Estimated

Enrollment

33Estimated

Phase

Phase 2

Conditions

Sarcoma of Pelvis

Interventions

Tasonermine (TNFa)
Melphalan

Countries

France

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

ID	Type	Description	Link
CSET 2003/1053

Status Module

Record Verification Date

Sep 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2004

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 16, 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

Jun 11, 2007

Last Update Posted Date

Jun 12, 2007Estimated

Description Module

Brief Summary

This study looks at isolated pelvic perfusion and limbs' girdle with 1 mg tumor necrosis factor alpha (TNFa) in the treatment of locally advanced sarcoma of the pelvis and limbs' girdle.

Detailed Description

Not provided

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

33Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complete response rate on MRI

Secondary Outcomes

Measure	Description	Time Frame
Histological response
Objective responses
Rate of conservative treatments

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Soft tissue or bone sarcomas locally advanced of the pelvis or limbs' girdle

Exclusion Criteria:

Resectable tumor without mutilation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sylvie Bonvalot, MD	Contact	33 1 42 11 363		bonvalot@igr.fr

Overall Officials

Name	Affiliation	Role
Sylvie Bonvalot, MD	Gustave Roussy, Cancer Campus, Grand Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut Gustave-Roussy	Recruiting	Villejuif		94800	France

Intervention Browse Module

MeSH Terms

ID	Term
D008558	Melphalan

Ancestor Terms

ID	Term
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Tasonermine (TNFa)	Drug
Melphalan	Drug