NCT02661152 (DAHANCA30) is a Phase 3 clinical trial of Nimorazole in Head and Neck Squamous Cell Carcinoma, sponsored by Danish Head and Neck Cancer Group.

Who is sponsoring NCT02661152?

NCT02661152 is sponsored by Danish Head and Neck Cancer Group.

What drugs are being tested in NCT02661152?

Interventions in NCT02661152: Nimorazole.

What condition does NCT02661152 study?

NCT02661152 studies Head and Neck Squamous Cell Carcinoma, Radiotherapy, Hypoxic Modification, Hypoxia, Gene Profile, Gene Signature.

Is NCT02661152 still recruiting?

NCT02661152 is currently status unknown. Last updated 12 April 2021.

Last reviewed 2021-04-12 · How we verify

NCT02661152: DAHANCA30

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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 unknown Phase 3 Last updated 12 April 2021

What this trial tests

Phase 3 trial testing Nimorazole in Head and Neck Squamous Cell Carcinoma in 1,252 participants. Status unknown.

Timeline

1 September 2016

Primary endpoint
1 December 2023

1 December 2023

Quick facts

Lead sponsor	Danish Head and Neck Cancer Group
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	1,252
Start date	1 September 2016
Primary completion	1 December 2023
Estimated completion	1 December 2023
Sites	1 location across Denmark

Drugs / interventions tested

Nimorazole (NIMORAZOLE) — full drug profile →

Conditions studied

Head and Neck Squamous Cell Carcinoma — all drugs for Head and Neck Squamous Cell Carcinoma →
Radiotherapy — all drugs for Radiotherapy →
Hypoxic Modification — all drugs for Hypoxic Modification →
Hypoxia — all drugs for Hypoxia →

Sponsor

Danish Head and Neck Cancer Group

Who can join

18 and older, any sex, with Head and Neck Squamous Cell Carcinoma or Radiotherapy. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Number of participants with locoregional tumour control
Time frame: 5 years
Patients are being followed with regular clinical examinations for 5 years after therapy. Side effects, tumour control and survival status is registered in the DAHANCA database. Interim analysis are planned every 12 months.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Tumor Hypoxia Regulates Immune Escape/Invasion: Influence on Angiogenesis and Potential Impact of Hypoxic Biomarkers on Cancer Therapies.
Abou Khouzam R, Brodaczewska K, Filipiak A, Zeinelabdin NA, et al · · 2020 · cited 135× · PMID 33552076 · DOI 10.3389/fimmu.2020.613114
Interfering with Tumor Hypoxia for Radiotherapy Optimization.
Telarovic I, Wenger RH, Pruschy M. · · 2021 · cited 119× · PMID 34154610 · DOI 10.1186/s13046-021-02000-x
Hypoxia-activated prodrugs and (lack of) clinical progress: The need for hypoxia-based biomarker patient selection in phase III clinical trials.
Spiegelberg L, Houben R, Niemans R, de Ruysscher D, et al · · 2019 · cited 85× · PMID 30734002 · DOI 10.1016/j.ctro.2019.01.005
Perspectives on Hypoxia Signaling in Tumor Stroma.
Zhang Y, Coleman M, Brekken RA. · · 2021 · cited 28× · PMID 34202979 · DOI 10.3390/cancers13123070
Combining imaging- and gene-based hypoxia biomarkers in cervical cancer improves prediction of chemoradiotherapy failure independent of intratumour heterogeneity.
Fjeldbo CS, Hompland T, Hillestad T, Aarnes EK, et al · · 2020 · cited 22× · PMID 32580139 · DOI 10.1016/j.ebiom.2020.102841
Targeting Hypoxia: Revival of Old Remedies.
Vilaplana-Lopera N, Besh M, Moon EJ. · · 2021 · cited 9× · PMID 34827602 · DOI 10.3390/biom11111604
Prognostic and Predictive Biomarkers in Head and Neck Squamous Cell Carcinoma Treated with Radiotherapy-A Systematic Review.
Schanne DH, Koch A, Elicin O, Giger R, et al · · 2022 · cited 6× · PMID 36552043 · DOI 10.3390/biomedicines10123288
Hypoxic gene expression is a prognostic factor for disease free survival in a cohort of locally advanced squamous cell cancer of the uterine cervix.
Alsner J, Overgaard J, Tramm T, Lindegaard JC. · · 2022 · cited 6× · PMID 34586924 · DOI 10.1080/0284186x.2021.1979249

Verify or expand the search:

Other trials of Nimorazole

Trials testing the same drug.

NCT01950689 — NIMRAD (A Randomised Placebo-controlled Trial of Synchronous NIMorazole Versus RADiotherapy Alone in Patients With Local · Phase 3 · completed
NCT01880359 — AF CRT +/- Nimorazole in HNSCC · Phase 3 · unknown

Other recruiting trials for Head and Neck Squamous Cell Carcinoma

Currently open trials in the same condition.

NCT06980038 — Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone i · Phase 2 · recruiting
NCT07503808 — A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types · Phase 1 · recruiting
NCT06995508 — Olanzapine for Managing Anorexia in Head and Neck Cancer Patients Undergoing Chemoradiation, MACRO Trial · Phase 2 · recruiting
NCT07254585 — SYS6010 Combined With Enlonstobart In Recurrent Or Metastatic Head And Neck Squamous Cell Carcinoma · Phase 2 · recruiting
NCT07514754 — Galenos 2 Immunonutrition in Head and Neck, Lung, and Rectal Cancer Patients · NA · recruiting

Other Danish Head and Neck Cancer Group trials

Trials by the same sponsor.

NCT03981068 — DAHANCA 37. Re-irradiation With Proton Radiotherapy · NA · unknown
NCT05423704 — Feasibility of Patient Selection and Treatment of Head-neck Cancer With Proton Therapy in Denmark · NA · active not recruiting
NCT05289336 — DAHANCA 27 Transoral Laser Microsurgery for T1a Glottic Cancer · Phase 2 · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02661152 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Danish Head and Neck Cancer Group
Last refreshed: 12 April 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02661152.

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