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Combined Chemotherapy With or Without Zoledronic Acid for Patients With Osteosarcoma

Study acronym: OS2006
StatusActive, Not Recruiting
PhasePhase 3
SponsorUNICANCER
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Study Status

    Re-verified, no change to tracked fields

    v17

  2. Minor

    Completion date: Dec 2025 to Dec 2026

    Study Statusv16

  3. Minor

    3 amendments

    3 re-verifications since 2021-06-05, no change to tracked fields

    v13-v15

  4. Notable

    Trial status: Terminated to Active, Not Recruiting

    Completion date: Apr 2025 to Dec 2025; Secondary endpoints: 4 to 3; Site details revised at 1 of 37 sites

    Show what changed: Secondary endpoints
    Quality of life

    Study Status, Arms and Interventions, Outcome Measures, Contacts/Locationsv12

  5. Notable

    Primary endpoint revised

    Secondary endpoints: details revised at 4 of 4 entries

    Show what changed: Primary endpoints
    ProgressionEvent-free survival

    Study Status, Outcome Measures, IPDSharingv11

Show 9 earlier versions

  1. Stopped

    Trial status: Recruiting to Terminated

    Sponsor's reason: IDMC decision upon interim efficacy analysis

    Enrollment target: estimated 440 to confirmed 318; Primary completion date: Dec 2015; Completion date: Apr 2025; and 5 more

    Show all 9 changes in this update
    • Stopped Trial status: Recruiting to Terminated
    • Minor Enrollment target: estimated 440 to confirmed 318
    • Minor Primary completion date: Dec 2015
    • Minor Completion date: Apr 2025
    • Minor Eligibility criteria shortened, about 7 words
      Show what changed
      DISEASEInclusion CHARACTERISTICS:Criteria Histologically confirmed high-grade osteosarcoma The following are excluded: Low-grade osteosarcoma Small cell osteosarcoma Maxillary osteosarcoma Primary resected osteosarcoma Extra-osseous osteosarcoma Any prior osteonecrosis of the maxilla PATIENT CHARACTERISTICS: Bilirubin ≤ 2 times upper limit of normal No medical conditi [...] al problem, including infection, traumatization, or surgery PRIORExclusion CONCURRENTCriteria Low-grade THERAPY:osteosarcoma Small cell osteosarcoma Maxillary osteosarcoma Primary resected osteosarcoma ⇅ moved Osteosarcoma with multiple m [...] [...]
    • Minor Site details revised at 37 of 37 sites
    • Minor Collaborators expanded, about 13 words
      Show what changed
      Novartis Chugai Pharmaceutical National Cancer Institute, France SFCE Ligue contre le cancer, France
    • Minor Study title shortened, about 1 word
      Show what changed
      CombinationCombined Chemotherapy With or Without Zoledronic Acid in Treatingfor Patients With Osteosarcoma
    • Minor Study arms: 0 to 2

    Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Design, Arms and Interventions, Eligibility, Contacts/Locationsv10

  2. Minor

    2 amendments

    2 re-verifications since 2008-07-23, no change to tracked fields

    v8-v9

  3. Minor

    Interventions: chemotherapy (Procedure), cisplatin (Drug), conventional surgery (Procedure), doxorubicin hydrochloride (Drug), etoposide (Drug), high-dose… to cisplatin (Drug), conventional surgery (Procedure), doxorubicin hydrochloride (Drug), etoposide (Drug), ifosfamide (Drug), methotrexate…

    Study Status, Arms and Interventionsv7

  4. Minor

    Study sites revised (37)

    Show what changed: Study sites
    Hopital Edouard Herriot - Lyon

    Study Status, Contacts/Locationsv6

  5. Minor

    Study Status

    Re-verified, no change to tracked fields

    v5

  6. Minor

    Interventions: Intervention/procedure (Procedure), chemotherapy (Procedure), cisplatin (Drug), conventional surgery (Procedure), doxorubicin hydrochloride… to chemotherapy (Procedure), cisplatin (Drug), conventional surgery (Procedure), doxorubicin hydrochloride (Drug), etoposide (Drug), high-dose…

    Study Status, Arms and Interventionsv4

  7. Minor

    Interventions: chemotherapy (Procedure), cisplatin (Drug), conventional surgery (Procedure), doxorubicin hydrochloride (Drug), etoposide (Drug), high-dose… to Intervention/procedure (Procedure), chemotherapy (Procedure), cisplatin (Drug), conventional surgery (Procedure), doxorubicin hydrochloride…

    Study Status, Arms and Interventionsv3

  8. Minor

    Study sites: 1 to 37

    Eligibility criteria shortened, about 2 words; Study description expanded, about 16 words

    Show what changed: Eligibility criteria
    DISEASE CHARACTERISTICS: Histologically confirmed high-grade osteosarcoma, not including any of the The following are excluded: Low-grade osteosarcoma Small cell osteosarcoma Maxillary o [...] cted osteosarcoma Osteosarcoma with multiple metastases for whomwhich complete removal is not feasible even after shrinkage with [...]
    Show what changed: Study description
    OBJECTIVES: Primary DetermineCompare the progression-free survival of patients with osteosarcoma tre [...] ion chemotherapy with or without zoledronic acid. Secondary DetermineCompare the overall survival of patients treated with these regimens. DetermineCompare the percentage of these patients with a good histologic response. DetermineCompare the long and short term toxicity of these regimens in these patients. DetermineCompare the quality of life inof patients treated with these regimens. OUTLINE: This is a ra [...] multicenter study. Patients are stratified according to age in years (< 18 years vs 18-25 [...]

    Study Status, Study Description, Eligibility, Contacts/Locationsv2

  1. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
UNICANCER
98 trials monitored
See 7 trials at risk
Sarcoma
951 trials monitored
See 57 trials at risk
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.
Trial Details
NCT Number NCT00470223
Lead Sponsor UNICANCER
Collaborators: Novartis, Chugai Pharmaceutical, National Cancer Institute, France, SFCE, Ligue contre le cancer, France
Conditions Sarcoma
Enrollment 318 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov