Trial intelligence / Profile preview

High-Dose Thiotepa in Relapsed Osteosarcoma

NCT00978471Phase 2

Key facts

Status: Completed
Start: Jul 2009
Primary completion: Oct 2018
Countries: 1
Sponsor: Centre Léon Bérard
Modality: Small Molecules

Drugs: thiotepa
Conditions: osteosarcoma (OS)

Overview

Phase 2, randomised, open-label trial of thiotepa in osteosarcoma (OS) (2 arms), sponsored by Centre Léon Bérard. Primary endpoint: Overall Survival at 24 months. Started Jul 2009; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Experimental arm thiotepa
High-Dose Thiotepa + Stem Cell Rescue + Surgery
Reference arm
Surgery (after conventional chemo)

Who it enrols

Patients aged 1-50 years with first or second relapse of osteosarcoma, eligible for chemotherapy and surgery, with adequate organ function.

Endpoints

Primary

Overall Survival24 months

Secondary

Overall Survival after Relapse Diagnosis24 months
Progression-Free Survival24 months
Hematologic Toxicityevery 3 weeks
Tumor Response Rate8 weeks after treatment
Histological Response12 to 17 weeks after inclusion

Beyond the preview

Go deeper on NCT00978471.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT00978471.