Overview

Combination Chemotherapy and Surgery With or Without G-CSF in Treating Patients With Osteosarcoma

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as G-CSF may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. It is not yet known whether chemotherapy and surgery plus G-CSF is more effective than chemotherapy and surgery alone in treating patients with osteosarcoma. PURPOSE: Randomized phase III trial to compare the effectiveness combination chemotherapy and surgery with or without G-CSF in treating patients who have newly diagnosed osteosarcoma.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Collaborator:
Medical Research Council
Treatments:
Doxorubicin
Lenograstim
Liposomal doxorubicin
Criteria
DISEASE CHARACTERISTICS:

- Histologically proven resectable osteosarcoma of the long bone of an extremity

- No parosteal (juxtacortical), periosteal, Pagetoid, or post-irradiation sarcoma

- No distant metastases

PATIENT CHARACTERISTICS:

Age:

- 40 and under

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Neutrophil count at least 1,500/mm^3 OR

- WBC at least 3,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.2 mg/dL

Renal:

- Glomerular filtration rate at least 60 mL/min

Cardiovascular:

- No history of cardiac dysfunction

Other:

- No other prior or concurrent malignancy except basal cell skin cancer OR

- Carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No other concurrent chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

Surgery:

- See Disease Characteristics

Other:

- No prior therapy