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Individualized Radiation Dose Prescription in HNSCC Based on F-MISO-PET Hypoxia-Imaging

Study acronym: INDIRA-MISO
StatusNot Yet Recruiting
PhasePhase 2
Started
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Record status
This record was last updated September 11, 2023 (before its estimated September 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Start date: Feb 1, 2023 to Jul 1, 2024
    • Enrollment target: 345 to 276
    • Study sites: 9 to 8
    v5
  2. Start date: Feb 1, 2022 to Feb 1, 2023v4
  3. Primary completion date: Sep 30, 2024 to Sep 30, 2025v3 Show 4 more changesShow less
    • Start date: Sep 1, 2019 to Feb 1, 2022
    • Study sites: 7 to 9
    • Study completion date: Sep 30, 2026 to Sep 30, 2027
    • Interventions: standard radiochemotherapy or dose-escalated radiochemotherapy (Radiation) to dose-escalated radiochemotherapy (Radiation), dose-escalated radiochemotherapy with carbon ion boost (Radiation), standard…
  4. Start date: Apr 7, 2019 to Sep 1, 2019
    • Secondary endpoints revised (4)
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 trial evaluates the value of radiation dose escalation based on Hypoxia detection by 18F\_misonidazole Positron Emission Tomography (18F-MISO-PET) for primary radiochemotherapy of head and neck squamous cell carcinoma. Patients negative for human papillomavirus (HPV) and with hypoxic tumours after 2 weeks of radiochemotherapy are randomized to completion of standard radiochemotherapy or radiochemotherapy with escalated radiation dose. An additional interventional arm includes a carbon ion boost. HPV positive tumours can be included in a control arm. Primary endpoint is local tumour control 2 years after radiochemotherapy.
Trial Details
NCT Number NCT03865277
Lead Sponsor Technische Universität Dresden
Conditions
(from sponsor)		 Head and Neck Squamous Cell Carcinoma
Related terms Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
Enrollment 276 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov