Study:
A Randomized Trial of the European and American Osteosarcoma Study Group to Optimize Treatment Strategies for Resectable Osteosarcoma Based on Histological Response to Pre-Operative Chemotherapy - A Phase III Intergroup Study
Rationale:
Drugs used in chemotherapy work in different ways to stop the growth of tumor
cells, either by killing the cells or by stopping them from dividing. Giving more than one
drug (combination chemotherapy) may kill more tumor cells. Biological therapies, such as
PEG-interferon alfa-2b, may interfere with the growth of tumor cells. Giving combination
chemotherapy before surgery may shrink the tumor so it can be removed. Giving combination
chemotherapy together with PEG-interferon alfa-2b after surgery may kill any remaining tumor
cells. It is not yet known whether giving combination therapy together with PEG-interferon
alfa-2b is more effective than two different combination chemotherapy regimens alone after
surgery in treating osteosarcoma.
Purpose:
This randomized phase III trial is studying combination chemotherapy followed by
surgery and two different combination chemotherapy regimens with or without PEG-interferon
alfa-2b to compare how well they work in treating patients with osteosarcoma.
Study Status: Active, not recruiting
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Sarcoma |
Biological: PEG-interferon alfa-2b
Drug: cisplatin
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: ifosfamide
Drug: methotrexate |
Phase 3 |
Verified by
Children`s Oncology Group
June, 2011
Sponsored by: Children`s Oncology Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov identifier: NCT00134030
Study Type: Interventional
Study Design: Allocation: Randomized, Primary Purpose: Treatment
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio 44195
United States
Neyssa M. Marina, MD., Study Chair
Mark L. Bernstein, MD, FRCPC.,
Mark L. Bernstein, MD, FRCPC., Study Chair