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

December 5, 2016 updated by: Italian Sarcoma Group

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Stuttgart, Germany, D-70176
        • Cooperative Osteosarcoma Study Group
  • Italy
      • Bologna, Italy, 40136
        • Istituti Ortopedici Rizzoli - Unit of chemotherapy of Muscoloskeletal Tumors
  • Sweden
      • Lund, Sweden, SE-221 85
        • Scandinavian Sarcoma Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

41 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients older than 40 years with highly malignant spindle cell sarcoma of bone

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • 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 Names:
  • Doxorubicin,cisplatin,ifosfamide,methotrexate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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
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
from the date of randomization until the end of the study, assessed every 3 months, up to 168 month
Chemotherapy toxicity
Time Frame: Every 3 weeks
Number and grade of adverse events related to the study treatments
Every 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Italian Sarcoma Group

Collaborators

Scandinavian Sarcoma Group
Cooperative Osteosarcoma Study Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

November 1, 2016

Study Registration Dates

First Submitted

November 25, 2016

First Submitted That Met QC Criteria

December 5, 2016

First Posted (ESTIMATE)

December 8, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 8, 2016

Last Update Submitted That Met QC Criteria

December 5, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EURO-B.O.S.S

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteosarcoma

Clinical Trials on Doxorubicin+cisplatin+ifosfamide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe