Osteosarcoma: Outcome of Therapy Based on Histologic Response. A Collaborative Effort of the POB/NCI, Texas Children's Hospital and University of Oklahoma.
- Determine the rate of in vivo histologic response in patients with osteosarcoma treated
with neoadjuvant cisplatin, methotrexate, and doxorubicin with dexrazoxane (as
- Determine the event-free and overall survival of patients with nonmetastatic disease
who show good response to neoadjuvant therapy and receive adjuvant therapy with the
- Determine the event-free survival of patients with nonmetastatic disease who show poor
response to neoadjuvant therapy and receive adjuvant therapy with the same regimen.
- Determine the event-free survival and overall survival of patients with metastatic
disease who receive neoadjuvant therapy.
OUTLINE: This is a multicenter study.
- Neoadjuvant therapy: Patients receive neoadjuvant chemotherapy comprising dexrazoxane
IV over 15 minutes, doxorubicin IV over 15 minutes, and cisplatin IV over 4 hours on
days 1 and 2 in week 0. Patients also receive methotrexate IV over 4 hours followed by
leucovorin calcium in weeks 3 and 4. Patients then receive filgrastim (G-CSF)
subcutaneously (SC) once daily beginning 24 hours after completion of chemotherapy and
continuing until blood counts recover. Treatment repeats every 5 weeks for 2 courses in
the absence of disease progression or unacceptable toxicity.
- Surgical resection: Patients undergo definitive surgery in week 11.
- Adjuvant therapy: Patients receive dexrazoxane, doxorubicin, cisplatin, methotrexate,
and leucovorin calcium as in neoadjuvant therapy*. Treatment repeats every 5 weeks for
up to 4 courses in the absence of disease progression or unacceptable toxicity.
NOTE: *Cisplatin is not administered in courses 3 and 4 of adjuvant therapy
Patients are followed within 4 weeks, every 3 months for 2 years, every 6 months for 2
years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 100 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Rate of in vivo histologic response
Ramzi Dagher, MD
National Cancer Institute (NCI)
United States: Federal Government
|Cook Children's Medical Center - Fort Worth||Fort Worth, Texas 76104|
|Oklahoma University Cancer Institute||Oklahoma City, Oklahoma 73104|
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office||Bethesda, Maryland 20892-1182|
|Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital||Houston, Texas 77030-2399|