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Palliative Dose Escalated Radiation for Painful Non-Spine Bone Metastases and Painful Non-Bone Metas

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion pushed from Apr 1, 2026 to Apr 1, 2027v8
  2. Notable Primary completion date: Apr 1, 2024 to Apr 1, 2026
    • Study completion date: Apr 1, 2024 to Apr 1, 2027
    • Site details revised at 1 of 7 sites
    v7
  3. Minor Study sites: 5 to 7v6
  4. Minor Start date changed from estimate of May 30, 2023 to Mar 16, 2023v5
  5. Notable Trial status: Suspended to Recruiting
    • Site details revised at 5 of 5 sites
    v4
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  1. Stopped Trial status: Not Yet Recruiting to Suspended Sponsor's reason: pending protocol amendment
    • Start date: Dec 30, 2022 to May 30, 2023
    • Site contacts updated at 3 of 5 sites
    v3
  2. Notable Start date: Jul 30, 2022 to Dec 30, 2022v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The investigators hypothesize that with dose escalation to 40-50 Gy in ten fractions, the complete pain response rate at one month can be increased to 40-50% in painful non-spinal bone metastases. Additionally, the investigators hypothesize that utilizing a fractionation scheme with an escalated biologically equivalent dose (BED) will result in a higher proportion of participants responding to treatment, and will also lead to more durable responses. Furthermore, the investigators hypothesize that with dose escalation to 40-50 Gy in ten fractions, the complete pain response rate at one month can be increased to 35-45% in painful non-bone metastases
Trial Details
NCT Number NCT05419518
Lead Sponsor Rutgers, The State University of New Jersey
Conditions
(from sponsor)
Neoplasm Metastases, Metastases, Neoplasm
Related terms Bone Neoplasms, Neoplasm Metastasis
Enrollment 124 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov