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

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:
Individualized Radiation Dose Prescription in HNSCC Based on F-MISO-PET Hypoxia-Imaging: Multi-center, Randomized Phase-II-trial

Clinical Trial 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.

Clinical Trial Description

Previous preclinical data and a prospective validated patient cohort have shown that patients with head and neck squamous cell carcinoma, whose tumours are hypoxic after 2 weeks of primary radiochmeotherapy, have a significantly lower chance of locoregional tumour control. The multi-center 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 (70 Gy) or radiochemotherapy with escalated radiation dose (77 Gy). An additional interventional arm includes a carbon ion boost to 77 Gy. HPV positive tumours can be included in a control arm. Primary endpoint is local tumour control 2 years after radiochemotherapy. Secondary endpoints include acute and late toxicity (CTCAE 5.0), regional tumor control, overall survival, disease free survival, distant metastases, kinetics analysis of dynamic FMISO-PET scans, Quality of life (QoL). The hypothesis is that local tumour control 2 years after radiochemotherapy is higher in the dose escalated compared to the control arm. ;

Study Design

Related Conditions & MeSH terms

  • Head and Neck Squamous Cell Carcinoma
  • Hypoxia
  • Squamous Cell Carcinoma of Head and Neck
Clinical Trial Details
NCT number NCT03865277
Study type Interventional
Source Technische Universität Dresden
Contact Mechthild Krause, Prof. Dr.
Phone +49 351 458 2238
Email mechthild.krause@uniklinikum-dresden.de
Status Not yet recruiting
Phase Phase 2
Start date July 1, 2024
Completion date September 30, 2027
View Details
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