Phase II Trial for the Treatment of Relapsed Osteosarcoma
- Registration Number
- NCT02718482
- Lead Sponsor
- Italian Sarcoma Group
- Brief Summary
Phase II randomized study for the comparison of the Gemcitabine plus Docetaxel and the Ifosfamide treatment of patients with relapsed osteosarcoma
- Detailed Description
Patients with relapsed osteosarcoma will be randomized to receive Gemcitabine plus Docetaxel or High Doses Ifosfamide (continuous infusion) every 3 weeks, up to 6 weeks
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 7
- Diagnosis of high grade osteosarcoma recurrence
- Resectable or unresectable recurrence disease within 24 months from the initial diagnosis
- Pleuro-pulmonary recurrence with more than 2 nodules within 24 months from the initial diagnosis
- Unresectable first relapse within 24 months from the initial diagnosis
- Resectable or unresectable second of further recurrence of high grade osteosarcoma
- Age at diagnosis at least 4years.
- Karnofsky performance status over 60%.
- Renal function and hepatic In normal limits for age.
- L eft ejection ventricular fraction over 50%.
- White blood cells over 3000 million/liter and platelets 100000 million/liter
- Birth potential female must agreed to contraception
- Signed written informed consent
- Contraindication to the use of any study drugs
- Mental, social and geographic conditions which fail to ensure adequate adherence to the study
- Hepatitis and human immunodeficiency virus active infection
- Pregnancy or breast-feeding
- Previous treatment with Gemcitabine, Docetaxel and Ifosfamide
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gemcitabine and Docetaxel Gemcitabine and Docetaxel Gemcitabine i.v. 900 mg/m2 in 30 min on day 1 and day 8 every 3 weeks Docetaxel i.v. 75 mg/m2 in 60 min on day 8 every 3 weeks Ifosfamide Ifosfamide Ifosfamide i.v. 14 g/m2 continous dose for 14 days every 3 weeks
- Primary Outcome Measures
Name Time Method Progression Free Survival at 6 months from randomization Survival without progression of disease assessed at 6 months from randomization
- Secondary Outcome Measures
Name Time Method Overall Survival At patient death or at last available follow-up From date of starting therapy until the date of death from any cause, whichever came first, assessed up to 60 months
Post treatment Surgery Rate After 6, 12 and 18 weeks Rate of patients who will require surgery after 2, 4 and 6 study treatment cycles
Overall Response Rate After 6, 12 and 18 weeks Rate of tumor response assessed after cycle 2, 4 and 6
Adverse Events Incidence Every 3 weeks up to 22 weeks Number and grade of adverse events related to the study treatments
Duration of hospitalization After 1,3, 4, 6, 7, 9, 10, 12, 13, 15, 16 and 18 weeks Number of days spent in hospital related to treatment received
Quality of life assesment: data will be collected by using specific oncologic Quality of Life instruments After 6, 12 and 18 weeks and at 12 Months after end of treatment Quality of Life evaluation related to received chemotherapy
Trial Locations
- Locations (10)
Fondazione del Piemonte per l'Oncologia IRCC Candiolo
🇮🇹Candiolo, Torino, Italy
Istituto Giannina Gaslini
🇮🇹Genova, Italy
Università seconda di Napoli
🇮🇹Napoli, Italy
Azienda Ospedaliera di Padova
🇮🇹Padova, Italy
Istituto Regina Elena - IFO
🇮🇹Rome, Italy
Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology
🇮🇹Torino, Italy
Ospedale Gradenigo
🇮🇹Torino, TO, Italy
Istituti Ortopedici Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors
🇮🇹Bologna, Italy
FONDAZIONE IRCCS Istituto Nazionale dei Tumori
🇮🇹Milano, Italy
A.O. Universitaria Meyer
🇮🇹Firenze, Italy