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
1 other identifier
interventional
60
1 country
1
Brief Summary
Aim: To improve curability of radiotherapy in HNSCC patients identified by hypoxic FAZA-PET scanning
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2017
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 22, 2016
CompletedFirst Posted
Study publicly available on registry
November 29, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedOctober 20, 2020
October 1, 2020
4.4 years
November 22, 2016
October 18, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Overall survival
Year 3
Acute radiation related morbidity
Month 3
Late radiation related morbidity
Year 3
Disease-specific death
Year 3
Study Arms (1)
Treatment with HART-CN
EXPERIMENTALHART-CN: Hyperfractionated accelerated radiotherapy with weekly concommitant cisplatin and nimorazole
Interventions
HART-CN: Hyperfractionated accelerated radiotherapy with weekly concommitant cis-platin and daily nimorazole
Eligibility Criteria
You may qualify if:
- Stage III-IV larynx, pharynx, oral cavity
- Hypoxic FAZA-PET positive
- Indication for primary radio-chemotherapy
- Informed consent
You may not qualify if:
- HPV positive oropharynx cancer
- Primary surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Experimental Clinical Oncology, Aarhus University Hospital
Aarhus, 8000 C, Denmark
Related Publications (1)
Mortensen LS, Johansen J, Kallehauge J, Primdahl H, Busk M, Lassen P, Alsner J, Sorensen 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 head and neck treated with radiotherapy: results from the DAHANCA 24 trial. Radiother Oncol. 2012 Oct;105(1):14-20. doi: 10.1016/j.radonc.2012.09.015. Epub 2012 Oct 16.
PMID: 23083497RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, MD DMSc
Study Record Dates
First Submitted
November 22, 2016
First Posted
November 29, 2016
Study Start
January 1, 2017
Primary Completion
June 1, 2021
Study Completion
December 1, 2022
Last Updated
October 20, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share