Clinical trial NCT02718482: Phase II Trial for the Treatment of Relapsed Osteosarcoma
Official title: Multicentric, Randomized Phase II Trial for the Treatment of Patients With Relapsed Osteosarcoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: OSTEOSARCOMA
Lead sponsor: Italian Sarcoma Group
Sponsor class: NETWORK
First posted: 2016-03-24
Enrollment: 7
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Progression Free Survival
timeFrame: at 6 months from randomization
Secondary outcomes:
measure: Overall Response Rate
timeFrame: After 6, 12 and 18 weeks
measure: Overall Survival
timeFrame: At patient death or at last available follow-up
measure: Post treatment Surgery Rate
timeFrame: After 6, 12 and 18 weeks
measure: Adverse Events Incidence
timeFrame: Every 3 weeks up to 22 weeks
measure: Quality of life assesment: data will be collected by using specific oncologic Quality of Life instruments
timeFrame: After 6, 12 and 18 weeks and at 12 Months after end of treatment
measure: Duration of hospitalization
timeFrame: After 1,3, 4, 6, 7, 9, 10, 12, 13, 15, 16 and 18 weeks
Other outcomes:
Locations:
city: Candiolo
country: Italy
facility: Fondazione del Piemonte per l'Oncologia IRCC Candiolo
state: Torino
city: Torino
country: Italy
facility: Ospedale Gradenigo
state: TO
city: Bologna
country: Italy
facility: Istituti Ortopedici Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors
city: Firenze
country: Italy
facility: A.O. Universitaria Meyer
city: Genova
country: Italy
facility: Istituto Giannina Gaslini
city: Milano
country: Italy
facility: FONDAZIONE IRCCS Istituto Nazionale dei Tumori
city: Napoli
country: Italy
facility: Università seconda di Napoli
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Rome
country: Italy
facility: Istituto Regina Elena - IFO
city: Torino
country: Italy
facility: Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology
Study officials:
affiliation: Istituto Ortopedico Rizzoli
name: Stefano Ferrari, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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, 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.
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.