A Randomised Trial of Two Chemotherapy Regimens in the Treatment of Operable Osteosarcoma (Doxorubicin-Cisplatin versus Methotrexate-Vincristine-Doxorubicin plus Doxorubicin-Cisplatin plus Bleomycin-Cyclophosphamide-Dactinomycin)
| ISRCTN | ISRCTN11824145 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11824145 |
| Secondary identifying numbers | BO03/EORTC 80861 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 12/04/2012
- 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=104
Contact information
Dr Barbara Uscinska
Scientific
Scientific
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
| Phone | +44 (0) 20 7670 4723 |
|---|---|
| register@ctu.mrc.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | To assess two protocols of chemotherapy in operable osteosarcoma. |
| Ethics approval(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Bone cancer |
| Intervention | Patients are randomised to one of two treatment groups: 1. Group A: Two drug chemotherapy, cisplatin and adriamycin (doxorubicin) repeated every 3 weeks for three cycles. Surgery is recommended 3 weeks following the completion of chemotherapy. Three further courses of chemotherapy to be given postoperatively. 2. Group B: Multi-drug chemotherapy with vincristine, high-dose methotrexate, adriamycin, bleomycin, cisplatin, cyclophosphamide and dactinomycin. The duration of chemotherapy is 44 weeks. Surgery is recommended for week 7 of chemotherapy. Regimen: Group A: Cisplatin 100 mg/m2 24 h infusion and adriamycin 25 mg/m2 days 1, 2, 3 at weeks 0, 3, 6, 9,11,14. Surgery week 9. Group B: High dose methotrexate (M) 8 g/m2 or 12 g/m2 (age 12 or less) 6 h infusion day 1; Vincristine (V) 1.5 mg/m2 (max 2 mg) iv bolus day 1; adriamycin (A1) 25 mg/m2 iv bolus, days 1-3; (A2) 30 mg/m2, days 1, 2; bleomycin (B) 15 mg/m2; cyclophosphamide (C) 600 mg/m2, dactinomycin (D) 600 mg/m2; cisplatin (P) 120 mg/m2; VM weeks 0, 1, 5, 6, 12, 13, 17, 18; A1 weeks 2, 14; A2+P weeks 20, 23, 29, 32, 38, 41; BCD weeks 9, 26, 35. Surgery week 7. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Doxorubicin-Cisplatin versus Methotrexate-Vincristine-Doxorubicin plus Doxorubicin-Cisplatin plus Bleomycin-Cyclophosphamid-Dactinomycin |
| Primary outcome measure | Overall survival, relapse-free survival, response to pre-operative chemotherapy |
| Secondary outcome measures | Not provided at time of registration. |
| Overall study start date | 01/06/1986 |
| Completion date | 01/03/1993 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 400 |
| Key inclusion criteria | 1. Aged <40 years 2. Biopsy proven osteosarcoma 3. Non-metastatic, untreated osteosarcoma of the long bones of an extremity 4. Normal cardiac, renal, hepatic, hematologic and pulmonary function prior to entry 5. Patients with parosteal, periosteal, pagetoid and post irradiation sarcoma or who have an inoperable tumour are excluded 6. No previous chemotherapy 7. No previous radiotherapy to the primary tumour 8. No medical contraindications to treatment |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 01/06/1986 |
| Date of final enrolment | 01/03/1993 |
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
Other
Medical Research Council, European Organisation for Research and Treatment of Cancer (EORTC)
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 | results | 27/09/1997 | Yes | No |
