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Pelvic Cancer Registry for Online Adapted Radiotherapy

Study acronym: PRoART
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Dec 2023 to Jan 1, 2024v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 2023 to Jan 1, 2024
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This prospective registry-based trial will include patients with pelvic or thoracic tumors with an indication for radiotherapy treated with oART or IGRT. For the primary endpoint and the secondary clinical endpoints, the trial will compare oART versus IGRT, for technical endpoints the trial will compare the real oART scenario with two virtual (hypothetical) control scenarios. Primary endpoint: * 10% reduction in the rate of acute radiotherapy related toxicity (≥ CTCAE II°, v5.0) using oART Secondary endpoints: * Clinical endpoints: Tumor control, late toxicities compared to conventional irradiated patients, quality of life and patient-reported outcomes * Technical endpoints: Target volume, target coverage, dose to organs at risk, anatomical variability score
Trial Details
NCT Number NCT06185062
Lead Sponsor University Medical Center Goettingen
Conditions Pelvic Tumor, Thoracic Tumor
Enrollment 846 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov