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ISRCTN
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ISRCTN11824145
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ClinicalTrials.gov identifier
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Public title
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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)
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Scientific title
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Acronym
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N/A
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Serial number at source
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BO03/EORTC 80861
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Study hypothesis
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To assess two protocols of chemotherapy in operable osteosarcoma
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Ethics approval
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Not provided at time of registration.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Bone cancer
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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Not provided at time of registration.
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Anticipated start date
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01/06/1986
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Anticipated end date
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01/03/1993
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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400
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Interventions
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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.
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Primary outcome measure(s)
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Overall survival, relapse-free survival, response to pre-operative chemotherapy
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Secondary outcome measure(s)
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Not provided at time of registration.
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Sources of funding
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Medical Research Council, European Organisation for Research and Treatment of Cancer (EORTC)
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Trial website
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Publications
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Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=9314869
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Contact name
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Dr
Barbara
Uscinska
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Address
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MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Tel
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+44 (0) 20 7670 4723
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Fax
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+44 (0) 20 7670 4818
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Email
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register@ctu.mrc.ac.uk
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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19/08/2002
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Last edited
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10/09/2007
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Date ISRCTN assigned
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19/08/2002
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