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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 ↗

Record History

  1. Re-verified, no change to tracked fieldsv17
  2. Completion date: Dec 2025 to Dec 2026v16
  3. 3 versions Re-verified since Jun 5, 2021, no change to tracked fieldsv13-v15
  4. 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 sitesv12 Show 3 more changesShow less
    • Completion date: Apr 2025 to Dec 2025
    • Secondary endpoints: 4 to 3
    • Site details revised at 1 of 37 sites

    See this version in full on ClinicalTrials.gov ↗

  5. Primary endpoint revised Secondary endpoints: details revised at 4 of 4 entriesv11 Show 1 more changeShow less
    • Secondary endpoints: details revised at 4 of 4 entries

    See this version in full on ClinicalTrials.gov ↗

Show 9 earlier versionsHide 9 earlier versions
  1. 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 · 5 morev10 Show 8 more changesShow less
    • Enrollment target: estimated 440 to confirmed 318
    • Primary completion date: Dec 2015
    • Completion date: Apr 2025
    • Eligibility criteria shortened, about 7 words
    • Site details revised at 37 of 37 sites
    • Collaborators expanded, about 13 words
    • Study arms: 0 to 2
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. 2 versions Re-verified since Jul 23, 2008, no change to tracked fieldsv8-v9
  3. 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…v7
  4. Study sites revised (37)v6 See this version in full on ClinicalTrials.gov ↗
  5. Re-verified, no change to tracked fieldsv5
  6. 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…v4
  7. 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…v3
  8. Study sites: 1 to 37 Study description expanded, about 16 words · Eligibility criteria shortened, about 2 wordsv2 Show 2 more changesShow less
    • Study description expanded, about 16 words
    • Eligibility criteria shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  1. 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 56 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