Clinical trial for the relapsed Osteosarcoma treatment

Phase 1

• Conditions: high grade relapsed osteosarcoma; MedDRA version: 20.0Level: PTClassification code 10031291Term: OsteosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-004762-28-IT
• Lead Sponsor: ITALIAN SARCOMA GROUP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-04
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1)High grade relapsed OS
2)Relapsed disease within 24months form the inital diagnosis
3) Plural-lung relapse with more than 2 nodules
4) First releapsed disease (regardless the site) not amenable for surgery
5) Second relapse regardless the site and resecability
6) Age = 4 yrs
7)Lansky score o Karnofsky Performance status >60%
8) Notrmal for age kidney and liver functionality
9) LVEF > 50%.
10) WBC 3 x 109/L, plateelets >100 x 109/l.
11) Negative pregnancy test for female and effective contraception method for potentially feritile females
For fertile female patients is required a contraception methods needs to be taken for all the treatment period. Contraception method for male patients need to taken up to 6 month to the end of treatment

12) Provvision of written Informed Consent
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Clincal controindications to the use of IMPs.
2) Social, psycological and geographical condition that could comprimise/jeopadize the study.
3) Active HIV, HBV e HCV infection
4) Pregnancy or breast feeding
5) Previous treatment with Gem-Dox and/or HD-IFO).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Efficacy, safety and clinical benefit in patients with relapsed osteosarcoma (OS) treated with High dose ifosfamide or with Gemcitabine+docetaxel;Secondary Objective: none;Primary end point(s): 6 months Progression Free Survival (PFS);Timepoint(s) of evaluation of this end point: 6 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Overall Survival (OS); Toxicity ; Quality of Life; Hospitalization time ; Rate of post-chemotheray surgical interventions; Overall Response Rate (ORR) Overall ;Timepoint(s) of evaluation of this end point: At time of death; After each cycle; At the end of Chemotheerap; fter each cycle; After 6 cycles; After 6 cycles