Italian Sarcoma Group: non-metastatic OsteoSarcoma 1
| ISRCTN | ISRCTN21335128 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21335128 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Via Pupilli 1
Bologna
40136
Italy
| Phone | +39 (0)51 636 6829 |
|---|---|
| stefano.ferrari@ior.it |
Study information
| Study design | Randomised controlled trial, open label |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Methotrexate (MTX), cisplatinum (CDP), doxorubicin (DOX) |
| Primary outcome measure | Clinical efficacy in terms of event free survival, disease free survival and overall survival. |
| Secondary outcome measures | To compare the toxicity of the two regiments. |
| Overall study start date | 02/04/2001 |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
40136
Italy
Sponsor information
Orthopaedic Institute Rizzoli (Istituti Ortopedici Rizzoli) (Italy)
Hospital/treatment centre
Hospital/treatment centre
c/o Piero Picci
Via di Barbiano 1/10
Bologna
40136
Italy
| Phone | +39 (0)51 636 6721 |
|---|---|
| piero.picci@ior.it | |
"ROR" |
https://ror.org/02ycyys66 |
Funders
Funder type
Hospital/treatment centre
Orthopaedic Institute Rizzoli (Istituti Ortopedici Rizzoli) (Italy)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
