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Completed

NCT Number: NCT02986503

European Study in Bone Sarcoma Patients Over 40 Years

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.

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Key information

Conditions

Spindle Cell Sarcoma of Bone Neoplasms Neoplasms by Histologic Type Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Osteosarcoma Sarcoma

Age range

41 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cooperative Osteosarcoma Study Group, Stuttgart, Germany

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Doxorubicin+cisplatin+ifosfamide

Drug

Chemotherapy for Good responder high grade osteosarcoma

Other names: Doxorubicin,cisplatin,ifosfamide

Doxorubicin+cisplatin+ifosfamide+methotrexate

Drug

Chemotherapy for Poor responder high grade osteosarcoma

Other names: Doxorubicin,cisplatin,ifosfamide,methotrexate

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Italian Sarcoma Group

Network

Collaborators

  • Cooperative Osteosarcoma Study Group
  • Scandinavian Sarcoma Group

Registry information

Official study title

A European Treatment Protocol for Bone-sarcoma in Patients Older Than 40 Years

Acronym: EUROBOSS

Important dates

Study start
2002
Primary completion
2015
Study completion
2016
First posted
Dec 8, 2016
Registry last updated
Dec 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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