EUCTR2012-001010-42-IT
Active, not recruiting
Not Applicable
A multicenter, prospective, randomized clinical trial for patients with relapsed osteosarcoma - ISG Os Rec
ConditionsHigh malignancy grade of osteosarcoma relapseMedDRA 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]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- High malignancy grade of osteosarcoma relapse
- Sponsor
- ITALIAN SARCOMA GROUP
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Not Applicable
A prospective, randomised, multicenter clinical trial investigating the reduction of Calcineurin inhibitor toxicity by means of steroid free long-term immune suppression with Ciclosporin A and Mycophenolat mofetil in children and adolescents after kidney transplantation - Recaltox-1EUCTR2007-001166-33-DEniversitaetsklinikum Erlangen-Nuernberg
Active, not recruiting
Not Applicable
se of the corifolitropina alfa in oocyte donorsThe study is proposed to determine the level of compliance and pharmacoeconomic impact of three protocols for controlled ovarian stimulation in women participating in oocyte donation programTherapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]EUCTR2014-001743-20-ESIVI Madrid
Completed
Phase 1
A multicenter randomized clinical study of using a three-dimensional printed patient personalized titanium plate in jaw surgeryManagement of dentofacial deformities through an orthognathic surgical interventionSurgeryISRCTN11838566West China Hospital of Stomatology, Sichuan University100
Active, not recruiting
Not Applicable
Multicenter, prospective, randomized clinical trial to assess two different doses of anti-human-T-lymphocyte immune serum preparation derived from rabbit in GVHD profilaxis in pediatric population with haematologic malignancies riceiving non allogenic stem cell transplantation. - NDgraft versus host disease profilactic useMedDRA version: 9.1Level: LLTClassification code 10018653Term: Graft-versus-host disease <GVHD>EUCTR2008-000101-11-ITOSPEDALE POLICLINICO S. MATTEO
Active, not recruiting
Not Applicable
Healing effectiveness of Algosteril vs Aquacel Extra in pilonidal sinusesISRCTN24794558Brothier (France)238