NCT02718482

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2016

Typical duration for phase_2

Geographic Reach
1 country

10 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 24, 2016

Completed
13 days until next milestone

Study Start

First participant enrolled

April 6, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2019

Completed
Last Updated

May 13, 2019

Status Verified

May 1, 2019

Enrollment Period

2.8 years

First QC Date

March 2, 2016

Last Update Submit

May 9, 2019

Conditions

OSTEOSARCOMA

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival

    Survival without progression of disease assessed at 6 months from randomization

    at 6 months from randomization

Secondary Outcomes (6)

  • Overall Response Rate

    After 6, 12 and 18 weeks

  • Overall Survival

    At patient death or at last available follow-up

  • Post treatment Surgery Rate

    After 6, 12 and 18 weeks

  • Adverse Events Incidence

    Every 3 weeks up to 22 weeks

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Gemcitabine and Docetaxel

EXPERIMENTAL

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

Drug: Gemcitabine and Docetaxel

Ifosfamide

EXPERIMENTAL

Ifosfamide i.v. 14 g/m2 continous dose for 14 days every 3 weeks

Drug: Ifosfamide

Interventions

Gemcitabine and DocetaxelDRUG

Treatment with gemcitabine and docetaxel at day 1 and day 8 n a 3 weeks cycle

Gemcitabine and Docetaxel
IfosfamideDRUG

Treatment arm with high doses of ifosfamide continous infusion for 14 days in a 3 weeks cycle

Also known as: High doses ifosfamide
Ifosfamide

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Fondazione del Piemonte per l'Oncologia IRCC Candiolo

Candiolo, Torino, 10060, Italy

Location

Ospedale Gradenigo

Torino, TO, 10153, Italy

Location

Istituti Ortopedici Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors

Bologna, 40136, Italy

Location

A.O. Universitaria Meyer

Florence, 50139, Italy

Location

Istituto Giannina Gaslini

Genova, Italy

Location

FONDAZIONE IRCCS Istituto Nazionale dei Tumori

Milan, Italy

Location

Università seconda di Napoli

Napoli, 80100, Italy

Location

Azienda Ospedaliera di Padova

Padua, Italy

Location

Istituto Regina Elena - IFO

Rome, 00100, Italy

Location

Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology

Torino, 10126, Italy

Location

Related Publications (4)

  • 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.

    PMID: 7850705BACKGROUND

  • 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.

    PMID: 8464555BACKGROUND

  • 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.

    PMID: 11821461BACKGROUND

  • 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.

    PMID: 20589638BACKGROUND

MeSH Terms

Conditions

Osteosarcoma

Interventions

GemcitabineDocetaxelIfosfamide

Condition Hierarchy (Ancestors)

Neoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsSarcoma

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsOxazines

Study Officials

  • Stefano Ferrari, MD

    Istituto Ortopedico Rizzoli

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2016

First Posted

March 24, 2016

Study Start

April 6, 2016

Primary Completion

January 7, 2019

Study Completion

January 7, 2019

Last Updated

May 13, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will share

Locations

IT(10)