Clinical trial · Interventional
DAHANCA 30: A Randomized Non-inferiority Trial of Hypoxia-profile Guided Hypoxic Modification of Radiotherapy of HNSCC.
DAHANCA 30: A Randomized Non-inferiority Trial of Hypoxia-profile Guided Hypoxic Modification With Nimorazole During Radiotherapy/Chemoradiotherapy of Squamous Cell Carcinoma of the Head and Neck.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gene Profile, Gene Signature | — | UNRESOLVED | — |
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Hypoxia | — | UNRESOLVED | — |
| Hypoxic Modification | — | UNRESOLVED | — |
| Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nimorazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Radio-/Chemoradiotherapy + nimorazole
- description
- Hypoxia profile guided non-responder (less hypoxic tumour) to nimorazole but receiving the drug, which is normal standard radiotherapy of HNSCC in Denmark.
- interventionNames
- Drug: Nimorazole
- type
- NO_INTERVENTION
- label
- Radio-/Chemoradiotherapy
- description
- Hypoxia profile guided non-responder (less hypoxic tumour) to nimorazole and not receiving the drug, that is normally part of standard radiotherapy of HNSCC in Denmark.
Primary outcomes (1)
- measure
- Number of participants with locoregional tumour control
- timeFrame
- 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Head and neck squamous cell carcinoma with indication for hypoxic modification with nimorazole in accordance to the Danish Head and Neck Cancer guidelines (DAHANCA guidelines). * Informed consent Exclusion Criteria: * Previous or present malignant disease conflicting with the radiotherapy treatment or evaluation of the treatment. * Participation in a conflicting protocol. * Initiation of radiotherapy more than 3 weeks after inclusion
References
Publications (1)
- DERIVEDWind 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. PMID 40889642