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SarcomaPhase 3OS2006NCT00470223

Combined Chemotherapy With or Without Zoledronic Acid for Patients With Osteosarcoma

A Phase 3 study testing cisplatin, doxorubicin hydrochloride and etoposide in people with Sarcoma, run by UNICANCER at 37 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 5 to 50 years
Conditions the study is for
Sarcoma
What is being tested?
cisplatin, doxorubicin hydrochloride and etoposide
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
318 participants
Where
37 sitesFrance
Study dates
Mar 2007to Dec 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 50 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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%
Show all 9Show fewer
  • LVEF ≥ 50%
  • Glomerular filtration rate ≥ 70mL/min
  • No recent dental problem, including infection, traumatization, or surgery

Who cannot join

  • 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

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

France37 sites

  • Centre Paul Papin

    Angers, 49036

  • Institut Gustave Roussy

    Angers, 49036

  • Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

    Besançon, 25030

  • CHR de Besancon - Hopital Saint-Jacques

    Besançon, 25030

  • Institut Bergonie

    Bordeaux, 33076

  • CHU Hopital A. Morvan

    Brest, 29609

  • CHU de Caen

    Caen, 14033

  • Centre Regional Francois Baclesse

    Caen, 14076

  • CHR Clermont Ferrand, Hotel Dieu

    Clermont-Ferrand, 63003

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Centre de Lutte Contre le Cancer Georges-Francois Leclerc

    Dijon, 21079

  • Centre Hospitalier Universitaire de Dijon

    Dijon, 21079

  • CHU de Grenoble - Hopital Michallon

    Grenoble, 38043

  • Centre Oscar Lambret

    Lille, 59020

  • Centre Leon Berard

    Lyon, 69373

  • Hopital Edouard Herriot - Lyon

    Lyon, 69437

  • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

    Marseille, 13273

  • CHU de la Timone

    Marseille, 13385

  • Hopital d'Enfants de la Timone

    Marseille, 13385

  • CHU Nord

    Marseille, 13915

  • Hopital Arnaud de Villeneuve

    Montpellier, 34295

  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

    Montpellier, 34298

  • Centre Antoine Lacassagne

    Nice, 06189

  • Hopital de l'Archet CHU de Nice

    Nice, F-06202

  • Institut Curie Hopital

    Paris, 75248

  • Hopital Jean Bernard

    Poitiers, 86021

  • Centre Eugene Marquis

    Rennes, 35042

  • Hopital Charles Nicolle

    Rouen, 76031

  • Centre Henri Becquerel

    Rouen, 76038

  • Centre Regional Rene Gauducheau

    Saint-Herblain, 44805

  • Institut de Cancerologie de la Loire

    Saint-Priest-en-Jarez, 42270

  • Hopitaux Universitaire de Strasbourg

    Strasbourg, 67091

  • Hopital Universitaire Hautepierre

    Strasbourg, 67098

  • Hopital des Enfants

    Toulouse, 31059

  • C.H. Bastien de Clocheville

    Tours, 3700

  • CHRU de Tours - Hopital Trousseau

    Tours, 37044

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511

Other trials in France

About this study

Official title: OS2006 : Protocole de Traitement Des ostéosarcomes de l'Enfant, de l'Adolescent et de l'Adulte Comportant

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.

Read the 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 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.

Conditions
Sarcoma
Keywords
localized osteosarcoma, metastatic osteosarcoma
Medical subject headings
Sarcoma, Osteosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00470223
Study groupRoleWhat they receive
Chemotherapy + zoledronic acidExperimentalNot described
Receives: Drug: cisplatin; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: ifosfamide; Drug: methotrexate; Drug: zoledronic acid; Procedure: conventional surgery
chemotherapyActive comparatorNot described
Receives: Drug: cisplatin; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: ifosfamide; Drug: methotrexate; Procedure: conventional surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event-free survival

    Measured: 3 years

Secondary outcomes (3)

  1. Overall survival

    Measured: 10 years

  2. Percentage of good responders

    Measured: at the time of the surgery

  3. Short term and long term toxicity

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2007 (estimated)
  2. Study startMar 2007
  3. Primary completionDec 2015
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
318 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00470223
Sponsor's protocol ID
Sarcome 09/0603
Other IDs
UNICANCER-SARCOME-09-0603, 2006-003377-27
Acronym
OS2006
Status last verified
May 2025
First submitted
3 May 2007
Last updated
8 Jun 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: IPD will not be shared at an individual level, they will be part of the study database including all enrolled patients.

Publications

  • Hattinger 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.

    PubMed 31401903

  • Lui 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.

    PubMed 29791011

  • Tabone 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.

    PubMed 28619014

  • Piperno-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.

    PubMed 27324280

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cisplatin, doxorubicin hydrochloride and etoposide in people with Sarcoma, run by UNICANCER at 37 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event-free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00470223, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.

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