Spindle Cell Sarcoma of BoneEUROBOSSNCT02986503
European Study in Bone Sarcoma Patients Over 40 Years
An observational study of Spindle Cell Sarcoma of Bone and Osteosarcoma, run by Italian Sarcoma Group at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 41 to 65 years
- Conditions the study is for
- Spindle Cell Sarcoma of Bone, Osteosarcoma
- What is being tested?
- Doxorubicin+cisplatin+ifosfamide and Doxorubicin+cisplatin+ifosfamide+methotrexate
- How many people
- 100 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jan 2002to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 41 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients older than 40 years with highly malignant spindle cell sarcoma of bone
Who may be able to join
- 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
Who cannot join
- 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%
Show all 9Show fewer
- 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.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Italy1 site
Istituti Ortopedici Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors
Bologna, Bologna, 40136
About this study
Official title: 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.
Read the 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).
- Conditions
- Spindle Cell Sarcoma of Bone, Osteosarcoma
- Being tested
- Doxorubicin+cisplatin+ifosfamide, Doxorubicin+cisplatin+ifosfamide+methotrexate
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxorubicin+cisplatin+ifosfamideDrug
Also called Doxorubicin,cisplatin,ifosfamide
Chemotherapy for Good responder high grade osteosarcoma
Doxorubicin+cisplatin+ifosfamide+methotrexateDrug
Also called Doxorubicin,cisplatin,ifosfamide,methotrexate
Chemotherapy for Poor responder high grade osteosarcoma
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy for Good responder | Doxorubicin + cisplatin + ifosfamide Pre-operative and post-operative chemotherapy for patients with good responder high grade osteosarcoma Receives: Drug: 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 Receives: Drug: Doxorubicin+cisplatin+ifosfamide+methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival
Survival without any events related to disease (e.g: progression, relapse or osteosarcoma related death)
Measured: 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 outcomes (5)
Progression-free survival
Survival without progression of disease
Measured: 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
Survival without disease
Measured: 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
Survival without metastasis
Measured: 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
Global patients survival evaluation after treatment
Measured: from the date of randomization until the end of the study, assessed every 3 months, up to 168 month
Chemotherapy toxicity
Number and grade of adverse events related to the study treatments
Measured: Every 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study startJan 2002
- Primary completionDec 2015
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spindle Cell Sarcoma of BoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Italian Sarcoma Group
- Sponsor type
- Research network
- Collaborators
- Scandinavian Sarcoma Group, Cooperative Osteosarcoma Study Group
- Responsible party
- Sponsor
- Investigators
- Stefano Ferrari, MD, Principal investigator, Italian Sarcoma Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986503
- Sponsor's protocol ID
- EURO-B.O.S.S
- Acronym
- EUROBOSS
- Status last verified
- Dec 2016
- First submitted
- 25 Nov 2016
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Anonymized results will be available upon request at the end of the study and public available into the repository systems like Clinicaltrial.gov
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A European Treatment Protocol for Bone-sarcoma in Patients Older Than 40 Years
- ClinicalTrials.gov ID
- NCT02986503
- Acronym / sponsor ID
- EUROBOSS / EURO-B.O.S.S
- Conditions
- Spindle Cell Sarcoma of Bone, Osteosarcoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Italian Sarcoma GroupResearch network
- Collaborators
- Scandinavian Sarcoma Group, Cooperative Osteosarcoma Study Group
- Study start
- Jan 2002
- Primary completion
- Dec 2015 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 8 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy for Good responder | – | Drug: Doxorubicin+cisplatin+ifosfamideDoxorubicin + cisplatin + ifosfamide Pre-operative and post-operative chemotherapy for patients with good responder high grade osteosarcoma |
| Chemotherapy for Poor responder | – | Drug: Doxorubicin+cisplatin+ifosfamide+methotrexateDoxorubicin+cisplatin+ifosfamide+methotrexate Pre-operative and post-operative chemotherapy for patients with poor responder high grade osteosarcoma |
Who may qualify
- Ages
- 41 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than 40 years with highly malignant spindle cell sarcoma of bone
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doxorubicin+cisplatin+ifosfamideAlso: Doxorubicin,cisplatin,ifosfamideChemotherapy for Good responder high grade osteosarcoma | Drug | Chemotherapy for Good responder |
| Doxorubicin+cisplatin+ifosfamide+methotrexateAlso: Doxorubicin,cisplatin,ifosfamide,methotrexateChemotherapy for Poor responder high grade osteosarcoma | Drug | Chemotherapy for Poor responder |
Primary outcome
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)
5 secondary outcomes
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
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
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
Overall survival
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2016.
- Euroboss I - A European treatment protocol for bone sarcoma in patients older than 40 yearsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized results will be available upon request at the end of the study and public available into the repository systems like Clinicaltrial.gov
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Ferrari, MD principal investigator
Italian Sarcoma Group
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spindle Cell Sarcoma of Bone and Osteosarcoma, run by Italian Sarcoma Group at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Italy, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2016.