Actively Recruiting
ARTSCAN VI - 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
260 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are investigating ways to personalize treatment for patients with head and neck squamous cell carcinoma (HNSCC), especially those with advanced disease who face a higher risk of treatment failure. This phase III study compares two radiotherapy approaches for patients intended for curative treatment: the standard radiotherapy and a hyperfractionated radiotherapy (HFX-RT) with a higher total radiation dose. The study also aims to improve prognostic and predictive methods by including exploratory analyses such as MRI to evaluate tumor hypoxia, gene profiling, immune profiling, and imaging texture analyses during treatment and follow-up. Participants will be randomly assigned to either standard radiotherapy, which delivers 68.0 Gy in daily fractions of 2.0 Gy, or to hyperfractionated radiotherapy, which delivers 83.0 Gy in smaller doses twice daily (1.22 Gy per fraction) over five days per week. The doses vary depending on the tumor volume and lymph node involvement. Patients with lower-risk tumors not eligible for randomization may still participate in the translational research parts of the study. During the study, participants will be closely monitored with regular follow-up visits every three months for two years, then every six months up to five years, focusing on local tumor control. Researchers will collect imaging data, conduct gene and protein analyses, and assess tumor response. The study evaluates treatment effects and tumor behavior over time to better understand and improve outcomes for head and neck cancer patients.
CONDITIONS
Brief 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...
- At least 18 years old
- Histologically or cytologically confirmed, previously untreated head and neck squamous cell carcinoma of the oropharynx, hypopharynx, larynx, or oral cavity without distant metastases
- Tumor size: for p16+ oropharyngeal cancer, tumor estimated at least 30 cc; for other subsites and p16- oropharyngeal cancer, tumor estimated at least 20 cc
- Treatment may be followed but not preceded by surgery except diagnostic excision of lymph node or tonsillectomy
- WHO/ECOG performance status 0-2
- Able to understand treatment information and provide written informed consent
You will not qualify if you...
- Previous radiotherapy in the head and neck region
- Concomitant or previous malignancies except uncomplicated basal cell carcinoma, early skin squamous cell carcinoma with at least one year follow-up, and other cancers with at least three years disease-free follow-up
- Two or more synchronous primary head and neck squamous cell carcinomas at diagnosis
- Nasopharyngeal cancer
- Sinonasal cancer
- Co-existing disease expected to limit survival to less than three years
- Pregnancy or lactation
- Psychiatric, addictive, or other medical conditions that may impair compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 7 weeks
Participants receive either standard radiotherapy once daily or hyperfractionated radiotherapy twice daily to treat head and neck cancer.
Daily visits, five to six days per week for standard radiotherapy or twice daily visits, five days per week for hyperfractionated radiotherapy
Duration - Up to 5 years
Participants are monitored to assess local tumour control after treatment.
Visits every three months for two years, then every six months up to five years
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
I
Ingrid Müchler
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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