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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004133-27-DK

Enrollment

1262

Registered

2016-02-26

Start date

2016-04-18

Completion date

Unknown

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with squamous cell carcinoma of the head and neck

Interventions

Product Name: Nimoral Pharmaceutical Form: Tablet INN or Proposed INN: nimorazole CAS Number: 6506-37-2 Other descriptive name: NIMORAZOLE Concentration unit: mg milligram(s) Concentration type: equal

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with HNSCC tumors where, in accordance with DAHANCA’s guidelines, hypoxic modification with nimorazole under primary radiotherapy is indicated. • In addition; a) No concurrent or earlier malignant diseases that can affect the treatment, evaluation and outcome of the actual disease b) Informed consent in accordance with regulations c) Radiotherapy planned to start within 3 weeks from inclusion d) Hypoxic status from gene profile testing must be available no later than by the initiation of radiotherapy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 868 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 394

Exclusion criteria

Exclusion criteria: NA

Design outcomes

Primary

Measure	Time frame
Main Objective: To show whether a hypoxic gene profile can classify patients that will have no effect of hypoxic modification with nimorazole during radiotherapy;Secondary Objective: To show reduced weight loss, reduced use of tube feeding and reduced patient reported nausea under radiotherapy of the group, randomised to not receiving nimorazole in comparison to those receiving nimorazole;Primary end point(s): Locoregional control after radiotherapy (not including possible salvage treatment). ;Timepoint(s) of evaluation of this end point: 2-3 months after finalised radiotherapy	—

Measure

Time frame

Main Objective: To show whether a hypoxic gene profile can classify patients that will have no effect of hypoxic modification with nimorazole during radiotherapy;Secondary Objective: To show reduced weight loss, reduced use of tube feeding and reduced patient reported nausea under radiotherapy of the group, randomised to not receiving nimorazole in comparison to those receiving nimorazole;Primary end point(s): Locoregional control after radiotherapy (not including possible salvage treatment). ;Timepoint(s) of evaluation of this end point: 2-3 months after finalised radiotherapy

—

Secondary

Measure	Time frame
Secondary end point(s): Local control (T-site), regional control (N-site), distant metastases, locoregional control after salvage treatment, overall survival (survival, disease- free survival, disease-specific survival), acute or late morbidity;Timepoint(s) of evaluation of this end point: 2-3 months after finalised radiotherapy	—

Countries

Denmark

Contacts

Public ContactJens Overgaard

Århus Univesitetshospital Afd. for Eksp Klinisk onkologi

jens@overgaard.au.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026