Phase II clinical study on efficacy of proton pump inhibitors pre-treatment in osteosarcoma patients undergoing chemiotherapy - Proton pump inhibitors in osteosarcoma patients

• Conditions: Osteosarcoma; MedDRA version: 9.1Level: LLTClassification code 10031293Term: Osteosarcoma localised

• Registration Number: EUCTR2006-005179-17-IT
• Lead Sponsor: ISTITUTI ORTOPEDICI RIZZOLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-02
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Histologically proven diagnosis of high-grade osteosarcoma of bone

Age 4-40
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Previous chemiotherapy treatment and or medical controindication to use one or more drugs

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Increase the percentage of patients presenting a good histological response (i.e. evidence of tumor necrosis after surgical treatment in >= 90% of patients) after the first chemiotherapy round including methotrexate, cisplatin and adriamycin;Secondary Objective: Evaluate whether pretreatment with PPI may reduce the bone marrow toxicity induced by the chemotherapy;Primary end point(s): good responders