Phase II Trial for the Treatment of Relapsed Osteosarcoma

OSTEOSARCOMA Clinical Trial

— OsteoREC2015  

Official title:

Multicentric, Randomized Phase II Trial for the Treatment of Patients With Relapsed Osteosarcoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02718482
• Other study ID #: OsteoREC2015
• Status: Terminated
• Phase: Phase 2
• Start date: April 6, 2016
• Est. completion date: January 7, 2019

Study information

• Verified date: May 2019
• Source: Italian Sarcoma Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase II randomized study for the comparison of the Gemcitabine plus Docetaxel and the Ifosfamide treatment of patients with relapsed osteosarcoma

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 information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: January 7, 2019
• Est. primary completion date: January 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• OSTEOSARCOMA

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Italy	Istituti Ortopedici Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors	Bologna
Italy	Fondazione del Piemonte per l'Oncologia IRCC Candiolo	Candiolo	Torino
Italy	A.O. Universitaria Meyer	Firenze
Italy	Istituto Giannina Gaslini	Genova
Italy	FONDAZIONE IRCCS Istituto Nazionale dei Tumori	Milano
Italy	Università seconda di Napoli	Napoli
Italy	Azienda Ospedaliera di Padova	Padova
Italy	Istituto Regina Elena - IFO	Rome
Italy	Ospedale Gradenigo	Torino	TO
Italy	Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Italian Sarcoma Group

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View Citation

Bielack SS, Kempf-Bielack B, Delling G, Exner GU, Flege S, Helmke K, Kotz R, Salzer-Kuntschik M, Werner M, Winkelmann W, Zoubek A, Jürgens 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. — View Citation

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. — View Citation

Saeter G, Høie 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival	Survival without progression of disease assessed at 6 months from randomization	at 6 months from randomization
Secondary	Overall Response Rate	Rate of tumor response assessed after cycle 2, 4 and 6	After 6, 12 and 18 weeks
Secondary	Overall Survival	From date of starting therapy until the date of death from any cause, whichever came first, assessed up to 60 months	At patient death or at last available follow-up
Secondary	Post treatment Surgery Rate	Rate of patients who will require surgery after 2, 4 and 6 study treatment cycles	After 6, 12 and 18 weeks
Secondary	Adverse Events Incidence	Number and grade of adverse events related to the study treatments	Every 3 weeks up to 22 weeks
Secondary	Quality of life assesment: data will be collected by using specific oncologic Quality of Life instruments	Quality of Life evaluation related to received chemotherapy	After 6, 12 and 18 weeks and at 12 Months after end of treatment
Secondary	Duration of hospitalization	Number of days spent in hospital related to treatment received	After 1,3, 4, 6, 7, 9, 10, 12, 13, 15, 16 and 18 weeks