Clinical trial NCT02986503: European Study in Bone Sarcoma Patients Over 40 Years
Official title: A European Treatment Protocol for Bone-sarcoma in Patients Older Than 40 Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spindle Cell Sarcoma of Bone
Osteosarcoma
Lead sponsor: Italian Sarcoma Group
Sponsor class: NETWORK
Collaborators: name: Scandinavian Sarcoma Group
name: Cooperative Osteosarcoma Study Group
First posted: 2016-12-08
Enrollment: 100
Sex: ALL
Minimum age (years): 41
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients older than 40 years with highly malignant spindle cell sarcoma of bone

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.

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).

Eligibility 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.

Primary outcomes:
measure: Event-free survival
timeFrame: 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:
measure: Progression-free survival
timeFrame: 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
measure: Disease-free survival
timeFrame: 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
measure: Metastasis-free survival
timeFrame: 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
measure: Overall survival
timeFrame: from the date of randomization until the end of the study, assessed every 3 months, up to 168 month
measure: Chemotherapy toxicity
timeFrame: Every 3 weeks
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Cooperative Osteosarcoma Study Group
city: Bologna
country: Italy
facility: Istituti Ortopedici Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors
city: Lund
country: Sweden
facility: Scandinavian Sarcoma Group
Study officials:
affiliation: Italian Sarcoma Group
name: Stefano Ferrari, MD
role: PRINCIPAL_INVESTIGATOR
References: