Condition category
Cancer
Date applied
15/02/2006
Date assigned
01/03/2006
Last edited
21/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stefano Ferrari

ORCID ID

Contact details

Via Pupilli 1
Bologna
40136
Italy
+39 (0)51 636 6829
stefano.ferrari@ior.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

ISG/OS-1

Study hypothesis

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

Ethics approval received from the Orthopaedic Institute Rizzoli (Istituti Ortopedici Rizzoli) on the 31st January 2001 (ref: 19/CE/US).

Study design

Randomised controlled trial, open label

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 Specified

Drug names

Methotrexate (MTX), cisplatinum (CDP), doxorubicin (DOX)

Primary outcome measures

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 trial start date

02/04/2001

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

246

Participant exclusion criteria

1. Metastatic osteosarcoma
2. Previous history of cancer
3. Co-existing disease contraindicating chemotherapy
4. No informed consent

Recruitment start date

02/04/2001

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Italy

Trial participating centre

Via Pupilli 1
Bologna
40136
Italy

Sponsor information

Organisation

Orthopaedic Institute Rizzoli (Istituti Ortopedici Rizzoli) (Italy)

Sponsor details

c/o Piero Picci
Via di Barbiano 1/10
Bologna
40136
Italy
+39 (0)51 636 6721
piero.picci@ior.it

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Orthopaedic Institute Rizzoli (Istituti Ortopedici Rizzoli) (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes