Back to resultsIsolated Pelvic and Limb Perfusion in the Treatment of Locally Advanced Sarcoma of Pelvis and Limbs' Girdle
Primary Purpose
Sarcoma of Pelvis
Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Tasonermine (TNFa)
Melphalan
Sponsored by
About this trial
This is an interventional treatment trial for Sarcoma of Pelvis focused on measuring Limbs' girdle
Eligibility Criteria
Inclusion Criteria: Soft tissue or bone sarcomas locally advanced of the pelvis or limbs' girdle Exclusion Criteria: Resectable tumor without mutilation
Sites / Locations
- Institut Gustave-RoussyRecruiting
Outcomes
Primary Outcome Measures
Complete response rate on MRI
Secondary Outcome Measures
Histological response
Objective responses
Rate of conservative treatments
Overall survival and disease free survival
Local and systemic toxicity
Full Information
NCT ID
NCT00181025
First Posted
September 13, 2005
Last Updated
June 11, 2007
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
1. Study Identification
Unique Protocol Identification Number
NCT00181025
Brief Title
Isolated Pelvic and Limb Perfusion in the Treatment of Locally Advanced Sarcoma of Pelvis and Limbs' Girdle
Official Title
Isolated Pelvic and Limb Perfusion With 1mg TNFa in the Treatment of Locally Advanced Sarcoma of Pelvis and Limbs' Girdle
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Unknown status
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma of Pelvis
Keywords
Limbs' girdle
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tasonermine (TNFa)
Intervention Type
Drug
Intervention Name(s)
Melphalan
Primary Outcome Measure Information:
Title
Complete response rate on MRI
Secondary Outcome Measure Information:
Title
Histological response
Title
Objective responses
Title
Rate of conservative treatments
Title
Overall survival and disease free survival
Title
Local and systemic toxicity
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Soft tissue or bone sarcomas locally advanced of the pelvis or limbs' girdle
Exclusion Criteria:
Resectable tumor without mutilation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sylvie Bonvalot, MD
Phone
33 1 42 11 363
Email
bonvalot@igr.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvie Bonvalot, MD
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Gustave-Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvie Bonvalot, MD
Phone
33 1 42 11 35 63
Email
bonvalot@igr.fr
12. IPD Sharing Statement
Learn more about this trial
Isolated Pelvic and Limb Perfusion in the Treatment of Locally Advanced Sarcoma of Pelvis and Limbs' Girdle
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