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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN11824145 |
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Date of registration:
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19/08/2002 |
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Prospective Registration:
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No |
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Primary sponsor: |
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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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Date of first enrolment:
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01/06/1986 |
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Target sample size:
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400 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN11824145 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Barbara
Uscinska |
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Address:
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MRC Clinical Trials Unit
222 Euston Road
NW1 2DA
London
United Kingdom |
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Telephone:
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+44 (0) 20 7670 4723 |
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Email:
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register@ctu.mrc.ac.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Exclusion criteria: Not provided at time of registration.
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bone cancer
Cancer
Osteosarcoma
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Intervention(s)
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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(s)
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Overall survival, relapse-free survival, response to pre-operative chemotherapy
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Secondary Outcome(s)
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Not provided at time of registration.
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Secondary ID(s)
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BO03/EORTC 80861
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Source(s) of Monetary Support
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Medical Research Council, European Organisation for Research and Treatment of Cancer (EORTC)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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