Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT00470223 |
| Other study ID # |
Sarcome 09/0603 |
| Secondary ID |
UNICANCER-SARCOM |
| Status |
Active, not recruiting |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
March 2007 |
| Est. completion date |
December 2026 |
Study information
| Verified date |
April 2024 |
| Source |
UNICANCER |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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. Zoledronic acid may stop the
growth of tumor cells in bone. Giving chemotherapy with or without zoledronic acid before
surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be
removed. Giving these treatments after surgery may kill any tumor cells that remain after
surgery. It is not yet known whether giving combination chemotherapy together with zoledronic
acid is more effective than combination chemotherapy alone in treating osteosarcoma.
PURPOSE: This randomized phase III trial is studying combination chemotherapy and zoledronic
acid to see how well they work compared with combination chemotherapy alone in treating
patients with osteosarcoma.
Description:
OBJECTIVES:
Primary
- Compare the progression-free survival of patients with osteosarcoma treated with
combination chemotherapy with or without zoledronic acid.
Secondary
- Compare the overall survival of patients treated with these regimens.
- Compare the percentage of patients with a good histologic response.
- Compare the long and short term toxicity of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (<
18 years vs 18-25 years vs > 25 years), risk group (nonmetastatic or resectable vs metastatic
or unresectable), and treatment center. Patients receive either methotrexate-based
chemotherapy or doxorubicin hydrochloride-based chemotherapy according to age.
- Methotrexate-based chemotherapy (patients ≤ 25 years of age): Patients are randomized to
1 of 2 treatment arms.
- Arm I: Patients receive methotrexate IV in weeks 1-3, 7, 8, 12, and 13 and
etoposide IV and ifosfamide IV in weeks 4 and 9.
- Arm II: Patients receive methotrexate, etoposide, and ifosfamide as in arm I.
Patients also receive zoledronic acid IV in weeks 1, 5, 9, and 13.
All patients undergo surgery in week 14. After surgery, patients are assigned to 1 of 2
groups for further treatment, based on histological response.
- Good responders (< 10% viable cells): Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive methotrexate IV in weeks 1-3, 7-9, 13-15, and 19-21 and
etoposide IV in weeks 4 and 10. Patients also receive ifosfamide IV in weeks 4, 10,
and 16.
- Arm II: Patients receive methotrexate, etoposide, and ifosfamide as in arm I.
Patients also receive zoledronic acid IV in weeks 3, 7, 11, 15, 19, and 23.
- Bad responders (> 10% viable cells): Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive methotrexate IV in weeks 1, 5, 9, 13, and 17 and
doxorubicin hydrochloride IV and cisplatin IV in weeks 2, 6, 10, 14, and 18.
- Arm II: Patients receive methotrexate, doxorubicin hydrochloride, and cisplatin as
in arm I. Patients also receive zoledronic acid IV as in arm II (good responders).
- Doxorubicin hydrochloride-based chemotherapy (patients ≥ 18 years of age):
Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive doxorubicin hydrochloride IV and ifosfamide hydrochloride IV in
weeks 1, 4, 7, 10, and 13 and cisplatin IV in weeks 1, 7, and 13.
- Arm II: Patients receive doxorubicin hydrochloride, ifosfamide, and cisplatin as in arm
I. Patients also receive zoledronic acid IV in weeks 1, 5, 9, and 13.
All patients undergo surgery in week 16. After surgery, patients are assigned to 1 of 2
groups for further treatment, based on histological response.
- Good responders (< 10% viable cells): Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive doxorubicin hydrochloride IV in weeks 1 and 7 and
ifosfamide IV in weeks 1, 4, 7, and 10.
- Arm II: Patients receive doxorubicin hydrochloride and ifosfamide as in arm I.
Patients also receive zoledronic acid IV in weeks 1, 5, 9, 13, 17, and 21.
- Bad responders (> 10% viable cells):
- Arm I: Patients receive etoposide IV and ifosfamide IV in weeks 1, 4, 7, 10, and
13.
- Arm II: Patients receive etoposide and ifosfamide as in arm I. Patients also
receive zoledronic acid as in arm II (good responders).
PROJECTED ACCRUAL: A total of 440 patients will be accrued for this study.
