Study of Effectiveness of GEMDOX in Relapsed Osteosarcoma | NCT04651179

Studies
Study of Effectiveness of GEMDOX in Relapsed Osteosarcoma

NCT04651179

Sponsor

Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

Status

Completed

Last Update Posted

Nov 26, 2021Actual

Enrollment

33Actual

Phase

Not provided

Conditions

Osteosarcoma Recurrent
Osteosarcoma Metastatic

Interventions

observation

Countries

Italy

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

Nov 2021

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

Apr 24, 2020Actual

Primary Completion Date

Jun 6, 2021Actual

Completion Date

Nov 23, 2021Actual

First Submitted Date

Nov 24, 2020

First Submission Date that Met QC Criteria

Dec 2, 2020

First Posted Date

Dec 3, 2020Actual

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

Nov 24, 2021

Last Update Posted Date

Nov 26, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Franca Fagioli, Principal Investigator, Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'AnnaPrincipal Investigator

Lead Sponsor

Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'AnnaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

A retrospective observational study of the effectiveness of gemcitabine - docetaxel in patients with relapsed osteosarcoma who have been treated with HD IFO in first line treatment

Detailed Description

Not provided

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

33Actual

Name	Type	Description	Arm Group Labels	Other Names
observation	Other	not applicable, observational study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Response to Gemcitabina - Docetaxel Treatment	assessed as overall survival (12 months)	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age at diagnosis of high grade osteosarcoma >= 4
Received first line treatment with HD IFO
Following HD IFO treatment, they have been diagnosed refractory disease and they satisfy at least one of the following criteria :
1. Relapsed in the first 24 month following the initial diagnosis, regardless of location and resectability
2. Lung relapsed disease with more than 2 nodules diagnosed over 24 months from the initial diagnosis
3. Non resectable relapsed disease diagnosed over 24 months from the initial diagnosis Before or during GEMDOX treatment, eligible patients may have been subject to metastasectomy

Exclusion Criteria: none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients with relapsed osteosarcoma treated with gemcitabine- docetaxel after a first line with HD- IFO

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Franca Fagioli, MD	AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istituto Nazionale Tumori		Milan	Milano	20133	Italy
Fondazione del Piemonte per l' Oncologia IRCCS Candiolo

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D008722	Methods
D008919	Investigative Techniques