Combined Chemotherapy With or Without Zoledronic Acid for Patients With Osteosarcoma

• Status: Active, not recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNICANCER
• Collaborators: Chugai Pharmaceutical; Ligue contre le cancer, France; National Cancer Institute, France; Novartis; SFCE
• Treatments: Diphosphonates; Doxorubicin; Etoposide; Ifosfamide; Liposomal doxorubicin; Methotrexate; Zoledronic Acid

Criteria

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