A randomised trial of chemotherapy with or without granulocyte colony-stimulating factor (G-CSF) in operable osteosarcoma

• Register: ISRCTN
• Last refreshed on: 23 May 2022
• Main ID: ISRCTN86294690
• Date of registration: 28/02/2001
• Prospective Registration: No
• Primary sponsor: Medical Research Council (MRC) (UK)
• Public title: A randomised trial of chemotherapy with or without granulocyte colony-stimulating factor (G-CSF) in operable osteosarcoma
• Scientific title: -
• Date of first enrolment: 01/07/1993
• Target sample size: 500
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN86294690
• Study type: Interventional
• Study design: Randomised controlled trial (Treatment)
• Phase: Not Specified

Countries of recruitment

England, United Kingdom

Contacts

• Name: Barbara Uscinska

Key inclusion & exclusion criteria

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

Exclusion criteria: Not provided at time of registration

Age minimum:
Age maximum:
Gender: Not Specified

Health Condition(s) or Problem(s) studied

Osteosarcoma
Cancer
Osteosarcoma

Intervention(s)

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.

Primary Outcome(s)

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

Secondary Outcome(s)

Not provided at time of registration

Secondary ID(s)

BO06

Source(s) of Monetary Support

Medical Research Council (MRC) (UK)

Ethics review

Status:
Approval date:
Contact:

Not provided at time of registration

Results

• Results available: Yes
• Date Completed: 30/09/2002