High malignancy grade of osteosarcoma relapse MedDRA version: 14.1 Level: PT Classification code 10031296 Term: Osteosarcoma recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: ENDOXAN BAXTER*EV 1FL 1G
Pharmaceutical Form: Powder for solution for infusion
CAS Number: 6055-19-2
Other descriptive name: Cyclophosphamide
Concentration unit: g gram(s)
Concentration ty
Sponsors
ITALIAN SARCOMA GROUP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.patients with high-grade malignant relapsed osteosarcoma 2.age at diagnosis 60% 4.First or subsequent relapse of osteosarcoma surgically unresectable or for whom surgery was oncologically not appropriate 5.Good organ function defined by: 1) serum creatinine 50%) 7.White blood cells >3 x 109/l and platelets >100 x 109/l 8.For female patients with childbearing potential, a negative test for pregnancy is to be considered before entry on study 9.Written signed informed consent from patients or from parents or legal guardians for minor patients, according to local law and regulations Are the trial subjects under 18? yes Number of subjects for this age range: 70 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 34 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Medical contraindications to the use of the drugs included in the Protocol. 2.Psychological conditions that don’t ensure either a good adhesion to the Protocol or a proper management of toxicity or a proper understanding of the study 3.Either HBV or HCV or HIV active infection 4.Previouly treatment with either Cyclophosphamide+ Etoposide or high dose Ifosfamide Pregnant or lactating patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy and tollerability of two chemotherapeutic regimens (either Cyclophosphamide+ Etoposide or high dose Ifosfamide) currently used to treat relapsed Osteosarcoma patients;Secondary Objective: To evaluate Clinical Benefit, Toxicity, Quality of life, Overall Survival, Progression Free Survival;Primary end point(s): Evaluation of the Overall Response Rate (ORR) defined as the percentage of patients with complete or partial response;Timepoint(s) of evaluation of this end point: after 2 chemotherapy cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluate: Number of patients with complete response or stable disease >=4 months Number of patients with toxicity grade =3 (NCI CTAE version 4.0) Number of patients with death for any cause since the date of randomization to the date of last available follow-up Number of patients with relapse/progression/death for any cause since the date of randomization to the date of last available follow-up Quality of life evaluation by PedsQLTM and EORTC QLQ-C30 criteria;Timepoint(s) of evaluation of this end point: After each cycle for toxicity,after 2 month for response and within 5 years for follow-up evaluations | — |
Countries
Italy
Contacts
Public ContactClinical Trial Office
Italian Sarcoma Group
Outcome results
None listed