Clinical trial · Interventional
Combined Chemotherapy With or Without Zoledronic Acid for Patients With Osteosarcoma
OS2006 : Protocole de Traitement Des ostéosarcomes de l'Enfant, de l'Adolescent et de l'Adulte Comportant
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| ifosfamide | Drug | Ifosfamide | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
| zoledronic acid | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Chemotherapy + zoledronic acid
- interventionNames
- Drug: cisplatin
- Drug: doxorubicin hydrochloride
- Drug: etoposide
- Drug: ifosfamide
- Drug: methotrexate
- Drug: zoledronic acid
- Procedure: conventional surgery
- type
- ACTIVE_COMPARATOR
- label
- chemotherapy
- interventionNames
- Drug: cisplatin
- Drug: doxorubicin hydrochloride
- Drug: etoposide
- Drug: ifosfamide
- Drug: methotrexate
- Procedure: conventional surgery
Primary outcomes (1)
- measure
- Event-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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
References
Publications (4)
- DERIVEDHattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14. PMID 31401903
- DERIVEDLui G, Treluyer JM, Fresneau B, Piperno-Neumann S, Gaspar N, Corradini N, Gentet JC, Marec Berard P, Laurence V, Schneider P, Entz-Werle N, Pacquement H, Millot F, Taque S, Freycon C, Lervat C, Le Deley MC, Mahier Ait Oukhatar C, Brugieres L, Le Teuff G, Bouazza N; Sarcoma Group of UNICANCER. A Pharmacokinetic and Pharmacogenetic Analysis of Osteosarcoma Patients Treated With High-Dose Methotrexate: Data From the OS2006/Sarcoma-09 Trial. J Clin Pharmacol. 2018 Dec;58(12):1541-1549. doi: 10.1002/jcph.1252. Epub 2018 May 23. PMID 29791011
- DERIVEDTabone MD, Brugieres L, Piperno-Neumann S, Selva MA, Marec-Berard P, Pacquement H, Lervat C, Corradini N, Gentet JC, Couderc R, Chevance A, Mahier-Ait Oukhatar C, Entz-Werle N, Blay JY, Le Deley MC. Prognostic impact of blood and urinary angiogenic factor levels at diagnosis and during treatment in patients with osteosarcoma: a prospective study. BMC Cancer. 2017 Jun 15;17(1):419. doi: 10.1186/s12885-017-3409-z. PMID 28619014
- DERIVEDPiperno-Neumann S, Le Deley MC, Redini F, Pacquement H, Marec-Berard P, Petit P, Brisse H, Lervat C, Gentet JC, Entz-Werle N, Italiano A, Corradini N, Bompas E, Penel N, Tabone MD, Gomez-Brouchet A, Guinebretiere JM, Mascard E, Gouin F, Chevance A, Bonnet N, Blay JY, Brugieres L; Sarcoma Group of UNICANCER; French Society of Pediatric Oncology (SFCE); French Sarcoma Group (GSF-GETO). Zoledronate in combination with chemotherapy and surgery to treat osteosarcoma (OS2006): a randomised, multicentre, open-label, phase 3 trial. Lancet Oncol. 2016 Aug;17(8):1070-1080. doi: 10.1016/S1470-2045(16)30096-1. Epub 2016 Jun 17. PMID 27324280