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DAHANCA 30: A Randomized Non-inferiority Trial of Hypoxia-profile Guided Hypoxic Modification of Radiotherapy of HNSCC. (DAHANCA30)

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ClinicalTrials.gov Identifier: NCT02661152
Recruitment Status : Recruiting
First Posted : January 22, 2016
Last Update Posted : April 13, 2021
Sponsor:
Information provided by (Responsible Party):
Danish Head and Neck Cancer Group

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Head and Neck Squamous Cell Carcinoma Radiotherapy Hypoxic Modification Hypoxia Gene Profile, Gene Signature Drug: Nimorazole Phase 3

Detailed Description:

Hypoxic modification of radiotherapy with nimorazole has in the DAHANCA 5 trial been shown to increase radiosensitivity in hypoxic head and neck squamous cell carcinomas (HNSCC).

Previously, it has not been possible to discriminate more hypoxic tumours from less hypoxic tumours. Thus, nimorazole has been added the radiotherapy of most HNSCC.

Recently, a hypoxia gene profile has been developed, that discriminate between more and less hypoxic tumours. The basis of the discrimination is the cumulated expression of 15 hypoxia responsive genes, quantified from the tumour biopsy.

The profile has been validated on the independent DAHANCA 5 cohort. There was a significant effect of adding nimorazole to the radiotherapy of more hypoxic tumours as estimated with the gene profile, whereas there was no effect of adding nimorazole to the less hypoxic tumours. In a test for interaction, there was a significantly different response to nimorazole in the more hypoxic tumours compared to the less hypoxic tumours.

In the Dahanca 30 trial it is aimed to verify, that there is no benefit of supplying the radiotherapy of less hypoxic HNSCC with nimorazole. Thus, to explore whether it is possible to avoid the sideeffects of nimorazole without risk for the patient.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Other
Official Title: 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.
Study Start Date : September 2016
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Radio-/Chemoradiotherapy + nimorazole
Hypoxia profile guided non-responder (less hypoxic tumour) to nimorazole but receiving the drug, which is normal standard radiotherapy of HNSCC in Denmark.
 Drug: Nimorazole
Hypoxia gene profile is expected to discriminate between HNSCC responders and non-responders to hypoxic modification with nimorazole during radiotherapy. In DAHANCA 30 expected non-responders are randomized to +/- nimorazole during radiotherapy (non-inferiority study). Thus, similar efficacy of radiotherapy is expected in these groups. More hypoxic tumours receive nimorazole after DAHANCA standards.
No Intervention: Radio-/Chemoradiotherapy
Hypoxia profile guided non-responder (less hypoxic tumour) to nimorazole and not receiving the drug, that is normally part of standard radiotherapy of HNSCC in Denmark.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Number of participants with disease specific survival [ 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Head and neck squamous cell carcinoma with indication for hypoxic modification with nimorazole in accordance to the Danish Head and Neck Cancer guidelines (DAHANCA guidelines).
  • Informed consent

Exclusion Criteria:

  • Previous or present malignant disease conflicting with the radiotherapy treatment or evaluation of the treatment.
  • Participation in a conflicting protocol.
  • Initiation of radiotherapy more than 3 weeks after inclusion
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02661152


Contacts
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Contact: Jens Overgaard, MD, DMSc +45 78462629 jens@oncology.au.dk
Contact: Kasper Thoustrup, MD, Ph.D. kasper@oncology.au.dk

Locations
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Denmark
Department of Experimental Clinical Oncology, Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000 C
Contact: Jens Overgaard, Prof., MD    +45 8949 2629    jens@oncology.au.dk   
Contact: Kasper G. Thoustrup, MD, PHD    +45 78462619    kasper@oncology.au.dk   
Sponsors and Collaborators
Danish Head and Neck Cancer Group
Investigators
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Study Chair: Jens Overgaard, MD DMSc DAHANCA Danish Head and Neck Group
More Information
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Responsible Party: Danish Head and Neck Cancer Group
ClinicalTrials.gov Identifier: NCT02661152    
Other Study ID Numbers: DAHANCA 30
First Posted: January 22, 2016    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Hypoxia
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
 Signs and Symptoms, Respiratory
Head and Neck Neoplasms
Neoplasms by Site
Nimorazole
Antitrichomonal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents