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)

Plain English Summary

http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=104

Study website

Type

Scientific

Contact name

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

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

BO03/EORTC 80861

Scientific title

Acronym

Study hypothesis

To assess two protocols of chemotherapy in operable osteosarcoma.

Ethics approval(s)

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Not specified

Study 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

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

Overall study end date

01/03/1993

Reason abandoned (if study stopped)

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(s)

Patient

Age group

Adult

Sex

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

Countries of recruitment

England, United Kingdom

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

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

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Not provided at time of registration

Study outputs