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Trial record 40 of 430 for:    ifosfamide

European Study in Bone Sarcoma Patients Over 40 Years (EUROBOSS)

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.
ClinicalTrials.gov Identifier: NCT02986503
Recruitment Status : Completed
First Posted : December 8, 2016
Last Update Posted : December 8, 2016
Sponsor:
Collaborators:
Scandinavian Sarcoma Group
Cooperative Osteosarcoma Study Group
Information provided by (Responsible Party):
Italian Sarcoma Group

Brief Summary:

The study is a first step of a process to establish the standard chemotherapy treatment with the aim to improve outcome for patients with these rare tumours. For this reason the study will be non-controlled clinical trial.

In this regard, the study aims to determine the feasibility of intensive chemotherapy in this age group, and/or separate efficacy analyses according to the different histologic categories and whether the number of patients recruited by the co-operating groups permits future randomised studies.


Condition or disease Intervention/treatment
Spindle Cell Sarcoma of Bone Osteosarcoma Drug: Doxorubicin+cisplatin+ifosfamide Drug: Doxorubicin+cisplatin+ifosfamide+methotrexate

Detailed Description:

Wide surgical removal of the tumor with the addition of a systemic treatment based on the antineoplastic drugs active against osteosarcoma (Adriamycin, Cisplatin, Ifosfamide, Methotrexate). The use of radiation therapy will be given to patients with unresectable tumors. It is recommended in patients who underwent inadequate surgical removal of the tumor. The addition of radiation therapy can not compensate for an adequate surgical treatment.

All the patients eligible for the study will receive the planned systemic treatment. Depending on clinical features, and feasibility of adequate surgical removal of the tumor, patients may receive primary chemotherapy followed by a postoperative chemotherapy treatment or only an adjuvant chemotherapy. In case of immediate surgery, patients will receive an adjuvant treatment with the 3-drug regimen (Cisplatin-Adriamycin-Ifosfamide).


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Study Type : Observational
Actual Enrollment : 100 participants
Time Perspective: Prospective
Official Title: A European Treatment Protocol for Bone-sarcoma in Patients Older Than 40 Years
Study Start Date : January 2002
Actual Primary Completion Date : December 2015
Actual Study Completion Date : November 2016


Group/Cohort Intervention/treatment
Chemotherapy for Good responder
Doxorubicin + cisplatin + ifosfamide Pre-operative and post-operative chemotherapy for patients with good responder high grade osteosarcoma
Drug: Doxorubicin+cisplatin+ifosfamide
Chemotherapy for Good responder high grade osteosarcoma
Other Name: Doxorubicin,cisplatin,ifosfamide

Chemotherapy for Poor responder
Doxorubicin+cisplatin+ifosfamide+methotrexate Pre-operative and post-operative chemotherapy for patients with poor responder high grade osteosarcoma
Drug: Doxorubicin+cisplatin+ifosfamide+methotrexate
Chemotherapy for Poor responder high grade osteosarcoma
Other Name: Doxorubicin,cisplatin,ifosfamide,methotrexate




Primary Outcome Measures :
  1. Event-free survival [ Time Frame: from the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 168 months. ]
    Survival without any events related to disease (e.g: progression, relapse or osteosarcoma related death)


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: from the date of randomization until the date of first documented progression of disease, whichever came first, assessed every 6 months, up to 168 months ]
    Survival without progression of disease

  2. Disease-free survival [ Time Frame: from the date of randomization until the date of first documented progression of disease, whichever came first, assessed every 6 months, up to 168 months ]
    Survival without disease

  3. Metastasis-free survival [ Time Frame: from the date of randomization until the date of first documented progression in term of metastasis, whichever came first, assessed every 3 months, up to 168 months ]
    Survival without metastasis

  4. Overall survival [ Time Frame: from the date of randomization until the end of the study, assessed every 3 months, up to 168 month ]
    Global patients survival evaluation after treatment

  5. Chemotherapy toxicity [ Time Frame: Every 3 weeks ]
    Number and grade of adverse events related to the study treatments



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Ages Eligible for Study:   41 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients older than 40 years with highly malignant spindle cell sarcoma of bone
Criteria

Inclusion Criteria:

  1. Histologically proven diagnosis of high-grade sarcoma of bone of any site.
  2. Histologic types: osteosarcoma (high-grade surface, central primary and secondary), fibrosarcoma, malignant fibrous histiocytoma, leiomyosarcoma, dedifferentiated chondrosarcoma, angiosarcoma.
  3. Age: 41 - 65
  4. Normal bone marrow, hepatic, cardiac and renal function
  5. Absence of contraindications to the use of cisplatin, adriamycin, and ifosfamide
  6. Written informed consent

Exclusion Criteria:

  1. Planned chemotherapy and/or follow-up not feasible
  2. Previous chemotherapy treatment, which contraindicates the use of one or more drugs, included in the present protocol
  3. Previous chemotherapy treatment for the current tumor
  4. White blood count < 3.0 x 109/L, and platelets < 100 x 109/L
  5. Creatinine clearance < 70 ml/min
  6. Left ventricular ejection fraction < 55% or fractional shortening rate of the left ventricle <28%
  7. Serum transaminases and bilirubin > 2 times the normal values
  8. ECOG performance status > 2
  9. Chondrosarcoma or small/round cell bone sarcoma including mesenchymal chondrosarcoma and Ewing's family tumors.

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 ClinicalTrials.gov identifier (NCT number): NCT02986503


Locations
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Germany
Cooperative Osteosarcoma Study Group
Stuttgart, Germany, D-70176
Italy
Istituti Ortopedici Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors
Bologna, Italy, 40136
Sweden
Scandinavian Sarcoma Group
Lund, Sweden, SE-221 85
Sponsors and Collaborators
Italian Sarcoma Group
Scandinavian Sarcoma Group
Cooperative Osteosarcoma Study Group
Investigators
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Principal Investigator: Stefano Ferrari, MD Italian Sarcoma Group

Additional Information:
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Responsible Party: Italian Sarcoma Group
ClinicalTrials.gov Identifier: NCT02986503     History of Changes
Other Study ID Numbers: EURO-B.O.S.S
First Posted: December 8, 2016    Key Record Dates
Last Update Posted: December 8, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized results will be available upon request at the end of the study and public available into the repository systems like Clinicaltrial.gov

Additional relevant MeSH terms:
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Ifosfamide
Isophosphamide mustard
Sarcoma
Osteosarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Cisplatin
Doxorubicin
Liposomal doxorubicin
Methotrexate
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Dermatologic Agents
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents