Combined Chemotherapy With or Without Zoledronic Acid for Patients With Osteosarcoma (OS2006)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00470223 |
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Recruitment Status :
Active, not recruiting
First Posted : May 7, 2007
Last Update Posted : April 18, 2024
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Sarcoma | Drug: cisplatin Drug: doxorubicin hydrochloride Drug: etoposide Drug: ifosfamide Drug: methotrexate Drug: zoledronic acid Procedure: conventional surgery | Phase 3 |
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| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 318 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | OS2006 : Protocole de Traitement Des ostéosarcomes de l'Enfant, de l'Adolescent et de l'Adulte Comportant |
| Actual Study Start Date : | March 2007 |
| Actual Primary Completion Date : | December 2015 |
| Estimated Study Completion Date : | December 2026 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Chemotherapy + zoledronic acid |
Drug: cisplatin Drug: doxorubicin hydrochloride Drug: etoposide Drug: ifosfamide Drug: methotrexate Drug: zoledronic acid Procedure: conventional surgery |
| Active Comparator: chemotherapy |
Drug: cisplatin Drug: doxorubicin hydrochloride Drug: etoposide Drug: ifosfamide Drug: methotrexate Procedure: conventional surgery |
- Event-free survival [ Time Frame: 3 years ]
- Overall survival [ Time Frame: 10 years ]
- Percentage of good responders [ Time Frame: at the time of the surgery ]
- Short term and long term toxicity [ Time Frame: 10 years ]
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| Ages Eligible for Study: | 5 Years to 50 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00470223
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| Study Chair: | Laurence Brugieres, MD | Gustave Roussy, Cancer Campus, Grand Paris |
| Responsible Party: | UNICANCER |
| ClinicalTrials.gov Identifier: | NCT00470223 |
| Other Study ID Numbers: |
Sarcome 09/0603 UNICANCER-SARCOME-09-0603 ( Other Identifier: UNICANCER ) 2006-003377-27 ( EudraCT Number ) |
| First Posted: | May 7, 2007 Key Record Dates |
| Last Update Posted: | April 18, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | IPD will not be shared at an individual level, they will be part of the study database including all enrolled patients. |
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localized osteosarcoma metastatic osteosarcoma |
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Osteosarcoma Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Neoplasms, Bone Tissue Neoplasms, Connective Tissue Zoledronic Acid Doxorubicin Liposomal doxorubicin Methotrexate Etoposide Ifosfamide Antineoplastic Agents Antibiotics, Antineoplastic |
Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Dermatologic Agents Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents |