| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN11824145 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | BO03/EORTC 80861 |
| Public title | 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) |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Bone cancer |
| Study hypothesis | To assess two protocols of chemotherapy in operable osteosarcoma |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration.
|
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - exclusion criteria | Not provided at time of registration.
|
| Patient information material |
|
| Anticipated start date | 01/06/1986 |
| Anticipated end date | 01/03/1993 |
| Status of trial | Completed |
| Target number of participants | 400 |
| Interventions | 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. |
| Primary outcome measure(s) | Overall survival, relapse-free survival, response to pre-operative chemotherapy |
| Secondary outcome measure(s) | Not provided at time of registration.
|
| Publications | Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=9314869 |
| Sources of funding | Medical Research Council, European Organisation for Research and Treatment of Cancer (EORTC) |
| Sponsor name | Medical Research Council (UK) |
| Sponsor details | 20 Park Crescent
London
United Kingdom
W1B 1AL |
| Sponsor telephone | +44 (0)20 7636 5422 |
| Sponsor fax | +44 (0)20 7436 6179 |
| Sponsor email | clinical.trial@headoffice.mrc.ac.uk |
| Sponsor website | http://www.mrc.ac.uk |
| Contact name | Dr Barbara Uscinska |
| Contact details | MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN11824145 |
| Date last extracted from ISRCTN register | 17/04/2008 |
