Plain English Summary
http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=107
Study website
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
BO06
Study information
Scientific title
-
Acronym
Study hypothesis
To compare two regimens of chemotherapy using Doxorubicin and Cisplatin in operable osteosarcoma: one involving chemotherapy at three weekly intervals with surgery after two courses, the other, chemotherapy at two weekly intervals plus G-CSF with surgery after three courses.
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
Osteosarcoma
Intervention
Two regimens of chemotherapy:
1. The first is Doxorubicin and Cisplatin at three weekly intervals with surgery after two courses/chemotherapy.
2. The second is Doxorubicin and Cisplatin at two weekly intervals plus G-CSF with surgery after three courses.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Doxorubicin and Cisplatin
Primary outcome measure
1. Survival time
2. Response rate
3. Morbidity
4. Response duration
Secondary outcome measures
Not provided at time of registration
Overall study start date
01/07/1993
Overall study end date
30/09/2002
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Untreated non-metastatic disease
2. Age less than or equal to 40 years
3. Neutrophils ≥1.5 times 10^9/l and platelets ≥100 times 10^9/l
4. Glomerular Filtration Rate (GFR) ≥60 ml/min/1.73 m^2
5. Serum bilirubin ≤ micromoles/L
6. Normal cardiac function
7. Informed consent
Participant type(s)
Patient
Age group
Adult
Sex
Not Specified
Target number of participants
500
Total final enrolment
497
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/07/1993
Recruitment end date
30/09/2002
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
UK Medical Research Council, MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
Not provided at time of registration
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 17/01/2007 | Yes | No | |
| Other publications | retrospective analysis | 01/05/2019 | 13/02/2020 | Yes | No |
| Other publications | retrospective analysis | 30/05/2019 | 28/04/2020 | Yes | No |
| Other publications | retrospective analysis | 16/12/2021 | 20/12/2021 | Yes | No |
| Other publications | retrospective reanalysis | 10/05/2022 | 11/05/2022 | Yes | No |