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

Phase 2

• Conditions: Hypoxic Radioresistance; Radiotherapy; Locally Advanced Head and Neck Cancer
• Interventions: Radiation: HART-CN

• Registration Number: NCT02976051
• Lead Sponsor: Danish Head and Neck Cancer Group

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

Study Timeline

• Study First Submitted: 2016-11-22
• Study First Submitted QC: 2016-11-28
• Study First Posted: 2016-11-29
• Study Start: 2017-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-18
• Last Update Posted: 2020-10-20
• Primary Completion: 2021-06
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment with HART-CN	HART-CN	HART-CN: Hyperfractionated accelerated radiotherapy with weekly concommitant cisplatin and nimorazole

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Acute radiation related morbidity	Month 3
Overall survival	Year 3	Death from all causes
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;

Trial Locations

Locations (1)

Department of Experimental Clinical Oncology, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark