A study Protocol for patients with relapsed osteosarcoma

• Conditions: High malignancy grade of osteosarcoma relapse; MedDRA version: 14.1Level: PTClassification code 10031296Term: Osteosarcoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2012-001010-42-IT
• Lead Sponsor: ITALIAN SARCOMA GROUP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-07
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.patients with high-grade malignant relapsed osteosarcoma 2.age at diagnosis <50 years 3.Lansky score o Karnofsky Performance status > 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 < 2 times the upper limit for age, 2) total bilirubin <1.5 times the upper limit of age, 3) transaminases = 2.5 times the upper limit for age, 4) alkaline phosphatase = 5 times the upper limit for age (with the exclusion of patients with skeletal metastases) 6.Normal Heart function (VEF > 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

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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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