DAHANCA 30

Phase 1

• Conditions: Patients with squamous cell carcinoma of the head and neck; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-004133-27-DK
• Lead Sponsor: Århus Universitetshospital Afd for Eksp. Klinisk onkologi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-26
• Last Update Posted: 15 January 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1262

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

NA

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).<br>;Timepoint(s) of evaluation of this end point: 2-3 months after finalised radiotherapy

Secondary Outcome Measures

Name	Time	Method
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