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

NCT02661152 | Unknown Phase 3 DMC

• 1 other identifier: DAHANCA 30
• Study Type: interventional
• Target: 1,252
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Squamous Cell Carcinoma; Radiotherapy; Hypoxic Modification; Hypoxia; Gene Profile, Gene Signature

Outcome Measures

Primary Outcomes (1)

• Number of participants with locoregional tumour control

  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.

  5 years

Secondary Outcomes (1)

• Number of participants with disease specific survival

  5 years

Study Arms (2)

Radio-/Chemoradiotherapy + nimorazole

EXPERIMENTAL

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

Radio-/Chemoradiotherapy

NO INTERVENTION

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.

Interventions

Nimorazole DRUG

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.

Radio-/Chemoradiotherapy + nimorazole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous or present malignant disease conflicting with the radiotherapy treatment or evaluation of the treatment.
• Participation in a conflicting protocol.

Sponsors & Collaborators

• Danish Head and Neck Cancer Group: lead

Study Sites (1)

Department of Experimental Clinical Oncology, Aarhus University Hospital

Aarhus, 8000 C, Denmark

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Hypoxia

Interventions

Nimorazole

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jens Overgaard, MD DMSc

  DAHANCA Danish Head and Neck Group

  STUDY CHAIR

Central Study Contacts

Jens Overgaard, MD, DMSc

CONTACT

+45 78462629; jens@oncology.au.dk

Kasper Thoustrup, MD, Ph.D.

CONTACT

kasper@oncology.au.dk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2016
• First Posted: January 22, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 13, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)