A randomised trial of chemotherapy with or without granulocyte colony-stimulating factor (G-CSF) in operable osteosarcoma
| ISRCTN | ISRCTN86294690 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86294690 |
| Protocol serial number | BO06 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- Submission date
- 28/02/2001
- Registration date
- 28/02/2001
- Last edited
- 11/05/2022
- 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
http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=107
Contact information
Dr Barbara Uscinska
Scientific
Scientific
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | - |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Doxorubicin and Cisplatin |
| Primary outcome measure(s) |
1. Survival time |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/09/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 500 |
| Total final enrolment | 497 |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/07/1993 |
| Date of final enrolment | 30/09/2002 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | 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 |
Editorial Notes
11/05/2022: Publication reference added.
20/12/2021: Publication reference added.
28/04/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
13/02/2020: Publication reference added.
