Actively Recruiting
a Multicentre Phase III Study of Risk-based Treatment Intensification With Hyperfractionated Radiotherapy in Head and Neck Cancer Patients
Led by Lund University Hospital · Updated on 2024-09-19
308
Participants Needed
11
Research Sites
469 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
There is an unmet need to personalise treatment for patients with head and neck squamous cell carcinoma (HNSCC) and to improve treatment results for patients with advanced disease. In this phase III study, HNSCC patients with prognostic factors indicating increased risk of treatment failure that are aimed for curative treatment with radiotherapy (RT) will be randomised between standard treatment (conventionally fractionated RT with final RT dose 68.0 Gy) and hyperfractionated RT (HFX-RT) with final RT dose 83.0 Gy. In order to find better prognostic and predictive tools the study also includes exploratory and translational analyses including evaluation of grade of hypoxia with Magnetic Resonance Imaging (MRI) and gene profiling by RNA-sequencing, tumour immune profiling, comparisons of global gene expression, gene aberrations and protein expression, and texture analyses of CT, FDG-PET and MRI images used during RT preparation and during patient follow-up. Patients with tumours with lower risk of recurrence, not eligible for randomisation in the study, can still participate in the translational parts of the study not investigating response to altered fractionation.
CONDITIONS
Official Title
a Multicentre Phase III Study of Risk-based Treatment Intensification With Hyperfractionated Radiotherapy in Head and Neck Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is at least 18 years old
- Histologically or cytologically confirmed, previously untreated HNSCC of the oropharynx, hypopharynx, larynx, or oral cavity without distant metastases
- Primary tumor size at least 30 cc for p16+ oropharyngeal cancer or at least 20 cc for other subsites or p16- oropharyngeal cancer by radiographic measurements
- Treatment may follow surgery but not be preceded by it, except diagnostic lymph node excision or tonsillectomy
- WHO/ECOG performance status between 0 and 2
- Ability to understand treatment information and provide written informed consent
You will not qualify if you...
- Previous radiotherapy to the head and neck region
- Current or past malignancies except uncomplicated basal cell carcinoma, early skin squamous cell carcinoma with at least one year follow-up, or other cancers with at least three years disease-free follow-up
- Two or more synchronous primary HNSCC at diagnosis
- Nasopharyngeal or sinonasal cancer
- Co-existing disease with expected survival less than three years
- Pregnancy or breastfeeding
- Psychiatric, addictive, or other medical conditions that might impair compliance
AI-Screening
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Trial Site Locations
Total: 11 locations
1
Gävle Hospital
Gävle, Sweden, SE-803 24
Not Yet Recruiting
2
Sahlgrenska University Hospital
Gothenburg, Sweden, SE-413 46
Not Yet Recruiting
3
Jönköping Hospital
Jönköping, Sweden, SE-553 05
Not Yet Recruiting
4
Karlstad Hospital
Karlstad, Sweden
Not Yet Recruiting
5
Linköping University hospital
Linköping, Sweden
Not Yet Recruiting
6
Lund University Hospital
Lund, Sweden, SE-221 85
Actively Recruiting
7
Örebro University Hospital
Örebro, Sweden, SE-703 82
Not Yet Recruiting
8
Karolinska University Hospital
Stockholm, Sweden, SE-171 64
Not Yet Recruiting
9
University Hospital
Umeå, Sweden, SE-907 37
Actively Recruiting
10
Uppsala Accademical Hospital
Uppsala, Sweden, SE-753 09
Not Yet Recruiting
11
Västmanlands Hospital Västerås
Västerås, Sweden
Actively Recruiting
Research Team
M
Maria Gebre-Medhin, MD
CONTACT
I
Ingrid Müchler
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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