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Phase II Trial for the Treatment of Relapsed Osteosarcoma (OsteoREC2015)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02718482
Recruitment Status : Terminated (Not adequate enrollment (sample size not possible to reach))
First Posted : March 24, 2016
Last Update Posted : May 13, 2019
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
OSTEOSARCOMA Drug: Gemcitabine and Docetaxel Drug: Ifosfamide Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicentric, Randomized Phase II Trial for the Treatment of Patients With Relapsed Osteosarcoma
Actual Study Start Date : April 6, 2016
Actual Primary Completion Date : January 7, 2019
Actual Study Completion Date : January 7, 2019

Arm Intervention/treatment
Experimental: 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
Drug: Gemcitabine and Docetaxel
Treatment with gemcitabine and docetaxel at day 1 and day 8 n a 3 weeks cycle

Experimental: Ifosfamide
Ifosfamide i.v. 14 g/m2 continous dose for 14 days every 3 weeks
Drug: Ifosfamide
Treatment arm with high doses of ifosfamide continous infusion for 14 days in a 3 weeks cycle
Other Name: High doses ifosfamide

Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: at 6 months from randomization ]
    Survival without progression of disease assessed at 6 months from randomization

Secondary Outcome Measures :
  1. Overall Response Rate [ Time Frame: After 6, 12 and 18 weeks ]
    Rate of tumor response assessed after cycle 2, 4 and 6

  2. Overall Survival [ Time Frame: 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

  3. Post treatment Surgery Rate [ Time Frame: After 6, 12 and 18 weeks ]
    Rate of patients who will require surgery after 2, 4 and 6 study treatment cycles

  4. Adverse Events Incidence [ Time Frame: Every 3 weeks up to 22 weeks ]
    Number and grade of adverse events related to the study treatments

  5. Quality of life assesment: data will be collected by using specific oncologic Quality of Life instruments [ Time Frame: After 6, 12 and 18 weeks and at 12 Months after end of treatment ]
    Quality of Life evaluation related to received chemotherapy

  6. Duration of hospitalization [ Time Frame: 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02718482

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Fondazione del Piemonte per l'Oncologia IRCC Candiolo
Candiolo, Torino, Italy, 10060
Ospedale Gradenigo
Torino, TO, Italy, 10153
Istituti Ortopedici Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors
Bologna, Italy, 40136
A.O. Universitaria Meyer
Firenze, Italy, 50139
Istituto Giannina Gaslini
Genova, Italy
FONDAZIONE IRCCS Istituto Nazionale dei Tumori
Milano, Italy
Università seconda di Napoli
Napoli, Italy, 80100
Azienda Ospedaliera di Padova
Padova, Italy
Istituto Regina Elena - IFO
Rome, Italy, 00100
Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology
Torino, Italy, 10126
Sponsors and Collaborators
Italian Sarcoma Group
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Principal Investigator: Stefano Ferrari, MD Istituto Ortopedico Rizzoli
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Responsible Party: Italian Sarcoma Group Identifier: NCT02718482    
Other Study ID Numbers: OsteoREC2015
First Posted: March 24, 2016    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Isophosphamide mustard
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Alkylating
Alkylating Agents