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 |
| Secondary identifying numbers | BO06 |
- 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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| 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 |
| Completion date | 30/09/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
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 | 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.
