Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
12/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Barbara Uscinska

ORCID ID

Contact details

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
+44 (0) 20 7670 4723
register@ctu.mrc.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BO03/EORTC 80861

Study information

Scientific title

Acronym

Study hypothesis

To assess two protocols of chemotherapy in operable osteosarcoma.

Ethics approval

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Doxorubicin-Cisplatin versus Methotrexate-Vincristine-Doxorubicin plus Doxorubicin-Cisplatin plus Bleomycin-Cyclophosphamid-Dactinomycin

Primary outcome measures

Overall survival, relapse-free survival, response to pre-operative chemotherapy

Secondary outcome measures

Not provided at time of registration.

Overall trial start date

01/06/1986

Overall trial end date

01/03/1993

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

Not provided at time of registration.

Recruitment start date

01/06/1986

Recruitment end date

01/03/1993

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Other

Funder name

Medical Research Council, European Organisation for Research and Treatment of Cancer (EORTC)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1997results on http://www.ncbi.nlm.nih.gov/pubmed/9314869

Publication citations

  1. Souhami RL, Craft AW, Van der Eijken JW, Nooij M, Spooner D, Bramwell VH, Wierzbicki R, Malcolm AJ, Kirkpatrick A, Uscinska BM, Van Glabbeke M, Machin D, Randomised trial of two regimens of chemotherapy in operable osteosarcoma: a study of the European Osteosarcoma Intergroup., Lancet, 1997, 350, 9082, 911-917, doi: 10.1016/S0140-6736(97)02307-6.

Additional files

Editorial Notes