Clinical trial • Oncology

NIMORAZOLE for Squamous cell carcinoma of the head and neck (HNSCC)

Clinical trial of NIMORAZOLE for Squamous cell carcinoma of the head and neck (HNSCC).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Squamous cell carcinoma of the head and neck (HNSCC)
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
30-10-2024
First CTIS Authorization Date
29-11-2024

Trial design

Randomised, radiotherapy/chemoradiotherapy without nimorazole (no nimorazole).-controlled trial in Denmark, Norway.

Randomised
Yes
Comparator
Radiotherapy/chemoradiotherapy without nimorazole (no nimorazole).
Biomarker Stratified
True, biomarker: hypoxia gene profile (hypoxic status)
Target Sample Size
1262

Eligibility

Recruits 1262 Vulnerable population not selected (isVulnerablePopulationSelected = false). Informed consent is required from participants (subject information and informed consent forms available for DK and NO). No specific assent/parental consent procedures for minors are indicated..

Pregnancy Exclusion
pregnancy or breast feeding.
Vulnerable Population
Vulnerable population not selected (isVulnerablePopulationSelected = false). Informed consent is required from participants (subject information and informed consent forms available for DK and NO). No specific assent/parental consent procedures for minors are indicated.

Inclusion criteria

  • {"criterion_text":"- Patients with HNSCC tumors where, in accordance with DAHANCA's guidelines, hypoxic modification with nimorazole under primary radiotherapy is indicated.\n- In addition; a) No concurrent or earlier malignant diseases that can affect the treatment, evaluation and outcome of the actual disease\n- b) Informed consent in accordance with regulations\n- c) Radiotherapy planned to start within 3 weeks from inclusion\n- d) Hypoxic status from gene profile testing must be available no later than by the initiation of radiotherapy."}

Exclusion criteria

  • {"criterion_text":"- Concurrent or previous malignant disease\n- enrollement in a competing trial\n- pregnancy or breast feeding."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Locoregional control after radiotherapy (not including possible salvage treatment).","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- 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","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
1262
Recruitment Window Months
161
Consent Approach
Informed consent is required from participants in accordance with regulations. Subject information and informed consent form documents are available (Danish and Norwegian versions). No details on assent or parental consent for minors are provided.

Geography

Total Number Of Sites
9
Total Number Of Participants
1262

Denmark

Earliest CTIS Part Ii Submission Date
20-11-2024
Latest Decision Or Authorization Date
29-11-2024
Processing Time Days
9
Number Of Sites
6
Number Of Participants
858

Sites

Site Name
Region Hovedstaden
Department Name
Dept of oncology
Contact Person Name
Christian Maare
Contact Person Email
christian.maare@regionh.dk
Site Name
Region Nordjylland
Department Name
Dept of oncology
Contact Person Name
Maria Andersen
Contact Person Email
maria.andersen@rn.dk
Site Name
Region Syddanmark
Department Name
Dept of oncology
Contact Person Name
Jørgen Johansen
Contact Person Email
j.johansen@dadlnet.dk
Site Name
Rigshospitalet
Department Name
Dept of oncology
Contact Person Name
Anita Birgitte Gothelf
Site Name
Region Midtjylland
Department Name
Dept of oncology
Contact Person Name
Hanne Primdahl
Contact Person Email
hannprim@rm.dk
Site Name
Næstved Hospital
Department Name
Dept of oncology
Contact Person Name
Mohammad Farhadi
Contact Person Email
mohf@regionsjaelland.dk

Norway

Earliest CTIS Part Ii Submission Date
20-11-2024
Latest Decision Or Authorization Date
29-11-2024
Processing Time Days
9
Number Of Sites
3
Number Of Participants
404

Sites

Site Name
St. Olavs Hospital HF
Department Name
Dept of oncology
Contact Person Name
Hanne Tøndel
Contact Person Email
hanne.tondel@ntnu.no
Site Name
Helse Bergen HF
Department Name
Dept of oncology
Contact Person Name
Åsa Karlsdottir
Site Name
Oslo University Hospital HF
Department Name
Dept of oncology
Contact Person Name
Åse Bratland
Contact Person Email
brt@ous-hf.no

Sponsor

Primary sponsor

Full Name
Region Midtjylland
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

Third parties

  • {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"sponsorDuties codes: 1, 9","organisation_type":"Educational Institution"}

Investigational products

Investigational Product Name
Nimoral tablets 500 mg
Active Substance
NIMORAZOLE
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
prodAuthStatus: 1
Maximum Dose
maxDailyDoseAmount: 3500 mg
Investigational Product Name
CISPLATIN
Active Substance
CISPLATIN
Modality
Small molecule
Routes Of Administration
Intravenous infusion
Route
Intravenous (infusion)
Authorisation Status
prodAuthStatus: 2
Maximum Dose
maxDailyDoseAmount: 40 mg/m2; maxTotalDoseAmount: 70 mg
Combination Treatment
Yes

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