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

Radiotherapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02976051
• Other study ID #: DAHANCA 33
• Status: Recruiting
• Phase: Phase 2
• Start date: January 2017
• Est. completion date: December 2022

Study information

• Verified date: October 2020
• Source: Danish Head and Neck Cancer Group
• Contact: Jens Overgaard, MD, DMSc
• Phone: +45 78462629
• Email: jens[@]oncology.au.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2022
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoxia
• Hypoxic Radioresistance
• Locally Advanced Head and Neck Cancer
• Radiotherapy

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of Experimental Clinical Oncology, Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Danish Head and Neck Cancer Group

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Mortensen LS, Johansen J, Kallehauge J, Primdahl H, Busk M, Lassen P, Alsner J, Sørensen BS, Toustrup K, Jakobsen S, Petersen J, Petersen H, Theil J, Nordsmark M, Overgaard J. FAZA PET/CT hypoxia imaging in patients with squamous cell carcinoma of the hea — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Loco-regional failure	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).	Year 3
Secondary	Overall survival	Death from all causes	Year 3
Secondary	Acute radiation related morbidity		Month 3
Secondary	Late radiation related morbidity		Year 3
Secondary	Disease-specific death	Disease-specific death is defined as death from or with the cancer in question;	Year 3