Phase II Trial for the Treatment of Relapsed Osteosarcoma
NCT ID: NCT02718482
Last Updated: 2019-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
7 participants
INTERVENTIONAL
2016-04-06
2019-01-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Gemcitabine and Docetaxel
Treatment with gemcitabine and docetaxel at day 1 and day 8 n a 3 weeks cycle
Ifosfamide
Ifosfamide i.v. 14 g/m2 continous dose for 14 days every 3 weeks
Ifosfamide
Treatment arm with high doses of ifosfamide continous infusion for 14 days in a 3 weeks cycle
Interventions
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Gemcitabine and Docetaxel
Treatment with gemcitabine and docetaxel at day 1 and day 8 n a 3 weeks cycle
Ifosfamide
Treatment arm with high doses of ifosfamide continous infusion for 14 days in a 3 weeks cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
4 Years
ALL
No
Sponsors
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Italian Sarcoma Group
NETWORK
Responsible Party
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Principal Investigators
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Stefano Ferrari, MD
Role: PRINCIPAL_INVESTIGATOR
Istituto Ortopedico Rizzoli
Locations
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Fondazione del Piemonte per l'Oncologia IRCC Candiolo
Candiolo, Torino, Italy
Ospedale Gradenigo
Torino, TO, Italy
Istituti Ortopedici Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors
Bologna, , Italy
A.O. Universitaria Meyer
Florence, , Italy
Istituto Giannina Gaslini
Genova, , Italy
FONDAZIONE IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Università seconda di Napoli
Napoli, , Italy
Azienda Ospedaliera di Padova
Padua, , Italy
Istituto Regina Elena - IFO
Rome, , Italy
Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology
Torino, , Italy
Countries
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References
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Saeter G, Hoie J, Stenwig AE, Johansson AK, Hannisdal E, Solheim OP. Systemic relapse of patients with osteogenic sarcoma. Prognostic factors for long term survival. Cancer. 1995 Mar 1;75(5):1084-93. doi: 10.1002/1097-0142(19950301)75:53.0.co;2-f.
Bacci G, Briccoli A, Ferrari S, Ruggieri P, Avella M, Casadei R, Battistini A, Picci P. [Osteosarcoma of the extremities metastatic at presentation. Results obtained with primary chemotherapy followed by simultaneous resection of the primary and metastatic lesion]. Minerva Chir. 1993 Jan;48(1-2):35-45. Italian.
Bielack SS, Kempf-Bielack B, Delling G, Exner GU, Flege S, Helmke K, Kotz R, Salzer-Kuntschik M, Werner M, Winkelmann W, Zoubek A, Jurgens H, Winkler K. Prognostic factors in high-grade osteosarcoma of the extremities or trunk: an analysis of 1,702 patients treated on neoadjuvant cooperative osteosarcoma study group protocols. J Clin Oncol. 2002 Feb 1;20(3):776-90. doi: 10.1200/JCO.2002.20.3.776.
Meazza C, Casanova M, Luksch R, Podda M, Favini F, Cefalo G, Massimino M, Ferrari A. Prolonged 14-day continuous infusion of high-dose ifosfamide with an external portable pump: feasibility and efficacy in refractory pediatric sarcoma. Pediatr Blood Cancer. 2010 Oct;55(4):617-20. doi: 10.1002/pbc.22596.
Other Identifiers
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OsteoREC2015
Identifier Type: -
Identifier Source: org_study_id
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