DAHANCA 33: Image Guided Dose-escalated Radiotherapy to Patients With Hypoxic HNSCC

DAHANCA 33: Functional Image Guided Dose-escalated Radiotherapy to Patients With Hypoxic Squamous Cell Carcinoma of the Head and Neck

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02976051

Enrollment

Registered

2016-11-29

Start date

2017-01-31

Completion date

2022-12-31

Last updated

2020-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxic Radioresistance, Locally Advanced Head and Neck Cancer, Radiotherapy

Brief summary

Aim: To improve curability of radiotherapy in HNSCC patients identified by hypoxic FAZA-PET scanning

Detailed description

Prospective phase II study aiming to improve the outcome in hypoxic resistent patients identified by FAZA-PET. Inclusion: Patients must fulfill the following: Positive hypoxic FAZA-PET Scanning (as described in DAHANCA 24 - see citation) Stage III-IV, Squamous cell carcinoma of the larynx, pharynx or oral cavity (HPVneg (oropharynx) Indication for hyperfractionated accelerated radiotherapy with concommitant cis-platin and nimorazole

Interventions

RADIATIONHART-CN

HART-CN: Hyperfractionated accelerated radiotherapy with weekly concommitant cis-platin and daily nimorazole

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Stage III-IV larynx, pharynx, oral cavity * Hypoxic FAZA-PET positive * Indication for primary radio-chemotherapy * Informed consent

Exclusion criteria

* HPV positive oropharynx cancer * Primary surgery

Design outcomes

Primary

Measure	Time frame	Description
Loco-regional failure	Year 3	loco-regional failure defined as persistent or recurrent disease in tumor and/or regional lymphnode sites (within the radiotherapy treated volume). The primary endpoint did not include the effect of a successful procedure with salvage surgery (no primary neck dissection was allowed).

Secondary

Measure	Time frame	Description
Overall survival	Year 3	Death from all causes
Acute radiation related morbidity	Month 3	—
Late radiation related morbidity	Year 3	—
Disease-specific death	Year 3	Disease-specific death is defined as death from or with the cancer in question;

Countries

Denmark

Contacts

Primary ContactJens Overgaard, MD, DMSc

jens@oncology.au.dk+45 78462629

Backup ContactMette Saksoe, MD

mette.saksoe@oncology.au.dk+45 78462629

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026