Osteosarcoma MedDRA version: 9.1 Level: LLT Classification code 10031293 Term: Osteosarcoma localised
Conditions
Interventions
Product Name: Esomeprazole
Pharmaceutical Form: Tablet
INN or Proposed INN: Esomeprazole
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Sponsors
ISTITUTI ORTOPEDICI RIZZOLI
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Previous chemiotherapy treatment and or medical controindication to use one or more drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Outcome results
None listed