Condition category
Cancer
Date applied
28/02/2001
Date assigned
28/02/2001
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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BO06

Study information

Scientific title

Acronym

Study hypothesis

To compare two regimens of chemotherapy using Doxorubicin and Cisplatin in operable osteosarcoma: one involving chemotherapy at three weekly intervals with surgery after two courses, the other, chemotherapy at two weekly intervals plus G-CSF with surgery after three courses.

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

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Osteosarcoma

Intervention

Two regimens of chemotherapy:
1. The first is Doxorubicin and Cisplatin at three weekly intervals with surgery after two courses/chemotherapy.
2. The second is Doxorubicin and Cisplatin at two weekly intervals plus G-CSF with surgery after three courses.

Intervention type

Drug

Phase

Not Specified

Drug names

Doxorubicin and Cisplatin

Primary outcome measures

1. Survival time
2. Response rate
3. Morbidity
4. Response duration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/07/1993

Overall trial end date

30/09/2002

Reason abandoned

Eligibility

Participant inclusion criteria

1. Untreated non-metastatic disease
2. Age less than or equal to 40 years
3. Neutrophils ≥1.5 times 10^9/l and platelets ≥100 times 10^9/l
4. Glomerular Filtration Rate (GFR) ≥60 ml/min/1.73 m^2
5. Serum bilirubin ≤ micromoles/L
6. Normal cardiac function
7. Informed consent

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

500

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/07/1993

Recruitment end date

30/09/2002

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

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17227995

Publication citations

  1. Results

    Lewis IJ, Nooij MA, Whelan J, Sydes MR, Grimer R, Hogendoorn PC, Memon MA, Weeden S, Uscinska BM, van Glabbeke M, Kirkpatrick A, Hauben EI, Craft AW, Taminiau AH, , , Improvement in histologic response but not survival in osteosarcoma patients treated with intensified chemotherapy: a randomized phase III trial of the European Osteosarcoma Intergroup., J. Natl. Cancer Inst., 2007, 99, 2, 112-128, doi: 10.1093/jnci/djk015.

Additional files

Editorial Notes