Clinical Trial

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

Study acronym: INDIRA-MISO
Not Yet Recruiting Phase 2
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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.
Summary
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2019-03-05; most recent amendment 2023-09-08.
Trial Details
NCT Number NCT03865277
Lead Sponsor Technische Universität Dresden
Conditions Head and Neck Squamous Cell Carcinoma
Enrollment 276 participants
Start Date 2024-07-01
Primary Completion 2025-09-30 (estimated)
Study Completion 2027-09-30 (estimated)
Updated on ClinicalTrials.gov 2023-09-11