Status:
ACTIVE_NOT_RECRUITING
Combined Chemotherapy With or Without Zoledronic Acid for Patients With Osteosarcoma
Lead Sponsor:
UNICANCER
Collaborating Sponsors:
Novartis
Chugai Pharmaceutical
Conditions:
Sarcoma
Eligibility:
All Genders
5-50 years
Phase:
PHASE3
Brief 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 ch...
Detailed 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 sur...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Histologically confirmed high-grade osteosarcoma
- Bilirubin ≤ 2 times upper limit of normal
- No medical condition that would preclude study treatment
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Shortening fraction ≥ 28%
- LVEF ≥ 50%
- Glomerular filtration rate ≥ 70mL/min
- No recent dental problem, including infection, traumatization, or surgery
- Exclusion Criteria
- Low-grade osteosarcoma
- Small cell osteosarcoma
- Maxillary osteosarcoma
- Primary resected osteosarcoma
- Osteosarcoma with multiple metastases for which complete removal is not feasible even after shrinkage with chemotherapy
- Extra-osseous osteosarcoma
- Any prior osteonecrosis of the maxilla
- No prior chemotherapy or radiotherapy
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2026
Estimated Enrollment :
318 Patients enrolled
Trial Details
Trial ID
NCT00470223
Start Date
March 1 2007
End Date
December 1 2026
Last Update
June 8 2025
Active Locations (37)
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1
Centre Paul Papin
Angers, France, 49036
2
Institut Gustave Roussy
Angers, France, 49036
3
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besançon, France, 25030
4
CHR de Besancon - Hopital Saint-Jacques
Besançon, France, 25030