Italian Sarcoma Group: non-metastatic OsteoSarcoma 1

ISRCTN	ISRCTN21335128
DOI	https://doi.org/10.1186/ISRCTN21335128
Protocol serial number	N/A
Sponsor	Orthopaedic Institute Rizzoli (Istituti Ortopedici Rizzoli) (Italy)
Funder	Orthopaedic Institute Rizzoli (Istituti Ortopedici Rizzoli) (Italy)

Submission date: 15/02/2006
Registration date: 01/03/2006
Last edited: 01/09/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Stefano Ferrari
Scientific

Via Pupilli 1
Bologna
40136
Italy

Phone	+39 (0)51 636 6829
Email	stefano.ferrari@ior.it

Study information

Primary study design	Interventional
Study design	Randomised controlled trial, open label
Secondary study design	Randomised controlled trial
Scientific title	Italian Sarcoma Group: non-metastatic OsteoSarcoma 1
Study acronym	ISG/OS-1
Study objectives	Osteosarcoma (OS) is a high-grade malignant spindle cell tumor arising within the bone and histologically characterized by the production of tumor osteoid or an immature bone directly from the malignant spindle cell stroma. It is the most frequent type of malignant bone tumor in children and adolescents. At present, the most effective drugs used are methotrexate (MTX), doxorubicin (DOX), ifosfamide (IFO), cisplatinum (CDP). Hypothesis: A chemotherapy treatment based on ifosfamide delivered only in the post-operative phase and in patients that are histologically poor responders to primary treatment with methotrexate (MTX), cisplatinum (CDP), doxorubicin (DOX) is equivalent to a treatment using ifosfamide added to MTX, CDP and DOX since the primary phase in all patients.
Ethics approval(s)	Ethics approval received from the Orthopaedic Institute Rizzoli (Istituti Ortopedici Rizzoli) on the 31st January 2001 (ref: 19/CE/US).
Health condition(s) or problem(s) studied	Osteosarcoma
Intervention	Patients are randomised to receive a treatment with methotrexate, doxorubicin, cisplatinum and ifosfamide since the primary treatment or to receive a primary treatment with methotrexate, doxorubicin and cisplatinum where ifosfamide is employed only in the post-operative phase in patients that are histologically poor responders to the primary treatment.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Methotrexate (MTX), cisplatinum (CDP), doxorubicin (DOX)
Primary outcome measure(s)	Clinical efficacy in terms of event free survival, disease free survival and overall survival.
Key secondary outcome measure(s)	To compare the toxicity of the two regiments.
Completion date	31/12/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	246
Total final enrolment	246
Key inclusion criteria	1. Patients with typical radiographic and histological features of primary, high-grade central osteosarcoma 2. Tumour located in the extremity 3. No previous history of cancer and no prior treatments 4. Aged under 40 5. No co-existing disease contraindicating chemotherapy 6. No evidence of metastases at diagnosis 7. Informed consent
Key exclusion criteria	1. Metastatic osteosarcoma 2. Previous history of cancer 3. Co-existing disease contraindicating chemotherapy 4. No informed consent
Date of first enrolment	02/04/2001
Date of final enrolment	31/12/2006

Locations

Countries of recruitment

Italy

Study participating centre

Via Pupilli 1

Bologna
40136
Italy

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		07/05/2012	01/09/2021	Yes	No

Editorial Notes

01/09/2021: Publication reference and total final enrolment added.