Therapeutic Response of Patients With Soft Tissue Sarcoma... | NCT01650077

Studies
Therapeutic Response of Patients With Soft Tissue Sarcoma According to CHOI Criteria

NCT01650077

Sponsor

Centre Oscar Lambret

Status

Completed

Last Update Posted

May 14, 2019Actual

Enrollment

134Actual

Phase

Not provided

Conditions

Soft Tissue Sarcoma

Interventions

Not provided

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

Status Module

Record Verification Date

May 2019

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

Sep 21, 2012Actual

Primary Completion Date

Dec 2013Actual

Completion Date

Oct 28, 2014Actual

First Submitted Date

Jul 19, 2012

First Submission Date that Met QC Criteria

Jul 23, 2012

First Posted Date

Jul 26, 2012Estimated

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

May 13, 2019

Last Update Posted Date

May 14, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Non-interventional study consisting of a population of patients who had received for soft tissue sarcoma by at least 2 courses of Yondelis® at a dose of 1.5 mg / m² / 3 weeks after failure or intolerance to doxorubicin / ifosfamide from 2007 to 2011.

Detailed Description

Patient selection is based on a database of retrospectively within the GSF / GETO.

The tumor assessment must be made by scanner at baseline and post-C2 or C3 and should be available and sent to sponsor.

The comparative reading of the imaging is centralized and made without the knowledge of the local assessment:

sum of the large diameter for 2 imagery (baseline and 1st evaluation
tumor density on areas of interest for the 2 imaging (baseline and 1st evaluation
Rank patients according to two methods (Choi and RECIST): complete response, partial response, stability, progress and non-assessable.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

134Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess the feasibility of tumor response according to CHOI criteria	percentage of cases with a feasible evaluation according to CHOI	after 6 weeks of treatment

Secondary Outcomes

Measure	Description	Time Frame
To classify patients into two categories (progression or no progression) according to RECIST and to CHOI	percentage of cases with a feasible evaluation according to RECIST	after 6 weeks of treatment
To determine percentage of false progression

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age ≥ 18 years
locally advanced or metastatic soft tissue sarcoma
treated with Yondelis after failure or intolerance to doxorubicin/ifosfamide
treated between 2007 and 2011
have had at least 2 cycles of Yondelis
assessment of tumor by CT scan (baseline and after 2 or 3 cycles of Yondelis)

Exclusion Criteria:

Gastro Intestinal Stromal Tumor GIST
primitive bone sarcoma

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with soft tissue sarcoma treated with at least 2 cycles of Yondelis after failure or intolerance to doxorubicin/ifosfamide

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nicolas PENEL, MD	Oscar Lambret Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bergonie Institute		Bordeaux		33 076	France
Oscar Lambret Center

Condition Browse Module

MeSH Terms

ID	Term
D012509	Sarcoma

Ancestor Terms

ID	Term
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided