DAHANCA 30: A Randomized Non-inferiority Trial of Hypoxia-profile Guided Hypoxic Modification of Radiotherapy of HNSCC.

Summary

Hypoxic modification of radiotherapy with nimorazole has previously been shown to increase radiosensitivity in hypoxic head and neck squamous cell carcinomas (HNSCC). In Denmark, nimorazole is added the radiotherapy of most HNSCC, as it has not previously been possible to discriminate more hypoxic tumours from less hypoxic tumours. A hypoxia gene profile has shown to discriminate between responders and non-responders to nimorazole. In DAHANCA 30, expected hypoxia profile guided non-responders are randomized to +/- nimorazole during radiotherapy.This in order to verify clinical use of the gene profile in selecting the relevant patients for hypoxic modification of radiotherapy with nimorazole.

Timeline

Start

2016-09

Primary completion

2023-12

Completion

2023-12

Publications

• Wind KL, Alsner J, Krag SP, Stribolt K, Lefevre AC, Toustrup K, Sorensen BS, Overgaard J, Spindler KG. Hypoxia-induced radioresistance in squamous cell carcinoma of the anus treated with radiotherapy - a validating study. Radiother Oncol. 2025 Nov;212:111118. doi: 10.1016/j.radonc.2025.111118. Epub 2025 Aug 30.

Drugs

Indications