Overview
Sponsor-declared trial summary
Head and neck squamous cell carcinoma (HNSCC)
To show comparable treatment response in a group of head and neck cancer patients predicted as non-responders to the hypoxic modifier nimorazol with a hypoxia gene profile, when these patients where randomized to concommitant nimorazole or not.
Key facts
- Sponsor
- Region Midtjylland
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 24 Aug 2016 → ongoing
- Decision date (initial)
- 2024-11-29
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516178-31-00
- EudraCT number
- 2015-004133-27
- ClinicalTrials.gov
- NCT02661152
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To show comparable treatment response in a group of head and neck cancer patients predicted as non-responders to the hypoxic modifier nimorazol with a hypoxia gene profile, when these patients where randomized to concommitant nimorazole or not.
Conditions and MedDRA coding
Head and neck squamous cell carcinoma (HNSCC)
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 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.
Exclusion criteria 1
- Concurrent or previous malignant disease, enrollement in a competing trial, pregnancy or breast feeding.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Locoregional control after radiotherapy (not including possible salvage treatment).
Secondary endpoints 1
- 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
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11639985 · Product
- Active substance
- Nimorazole
- Substance synonyms
- NITRIMIDAZINE
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 3500 mg milligram(s)
- Max total dose
- 75000 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Not Authorised
- ATC code
- L01XD — AGENTS USED IN PHOTODYNAMIC THERAPY
- MA holder
- AARHUS UNIVERSITY HOSPITAL
- Paediatric formulation
- No
- Orphan designation
- No
Auxiliary 1
SCP134220 · ATC
- Active substance
- Cisplatin
- Substance synonyms
- Cis-diamminedichloroplatinum, (SP-4-2)-cis -diamminedichloroplatinum, CDDP
- Route of administration
- INFUSION
- Max daily dose
- 40 mg/m2 milligram(s)/square meter
- Max total dose
- 70 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Midtjylland
- Sponsor organisation
- Region Midtjylland
- Address
- Palle Juul-Jensens Boulevard 99
- City
- Aarhus N
- Postcode
- 8200
- Country
- Denmark
Scientific contact point
- Organisation
- Region Midtjylland
- Contact name
- Kasper Toustrup
Public contact point
- Organisation
- Region Midtjylland
- Contact name
- Kasper Toustrup
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Aarhus Universitet ORG-100028380
|
Aarhus N, Denmark | On site monitoring, Code 9 |
Locations
2 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruitment ended | 858 | 6 |
| Norway | Ongoing, recruitment ended | 404 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2016-08-24 | 2016-08-29 | 2024-12-07 | ||
| Norway | 2016-08-24 | 2017-06-28 | 2024-12-07 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | DAHANCA 30 protocol for CTIS | 1.17 |
| Recruitment arrangements (for publication) | Placeholder document | 1 |
| Recruitment arrangements (for publication) | Placeholder document | 1 |
| Subject information and informed consent form (for publication) | Pasientsamtykke DAHANCA 30 til CTIS NO | 1.14 |
| Subject information and informed consent form (for publication) | Subject information and informed consent form DAHANCA 30 protokol DK | 1.17 |
| Synopsis of the protocol (for publication) | Synopsis of DAHANCA 30 protokol in danish | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-30 | Denmark | Acceptable 2024-11-28
|
2024-11-29 |