Personalized treatment intensification for head and neck cancer patients
ARTSCAN VI Protocol Version 1, 2023-07-03 ARTSCAN VI - a Multicentre Phase III Study of Risk-based Treatment Intensification With Hyperfractionated Radiotherapy in Head and Neck Cancer Patients
This study is testing whether personalizing treatment for head and neck cancer patients by using different types of radiotherapy can lead to better outcomes.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 308 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Lund University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 11 sites (Gävle and 10 other locations) |
| Trial ID | NCT06248996 on ClinicalTrials.gov |
What this trial studies
This phase III study aims to improve treatment outcomes for patients with head and neck squamous cell carcinoma (HNSCC) by personalizing their treatment based on risk factors for treatment failure. Patients will be randomized to receive either standard radiotherapy or hyperfractionated radiotherapy, which delivers a higher total dose of radiation in smaller fractions. The study also includes exploratory analyses to evaluate tumor characteristics and treatment response using advanced imaging and genetic profiling techniques. This approach seeks to identify better prognostic tools and enhance the effectiveness of treatment for advanced HNSCC.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with untreated, high-risk head and neck squamous cell carcinoma without distant metastases.
Not a fit: Patients with low-risk tumors or those who have received prior treatment for head and neck cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment options for patients with advanced head and neck cancer, potentially improving survival rates.
How similar studies have performed: Other studies have shown promise with hyperfractionated radiotherapy approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. The patient must be at least 18 years old. 2. Histologically or cytologically confirmed, previously untreated, HNSCC of the oropharynx, hypopharynx, larynx or oral cavity without distant metastases and aimed for treatment with radiotherapy (with or without concomitant chemotherapy) with curative intent. 3. The primary tumour must fulfil the following high-risk criteria: 1. For p16+ oropharyngeal cancer: Radiographic measurement of threeorthogonal diameters must render a tumour estimate of ≥30 cc. 2. For all other subsites and for p16- oropharyngeal cancer: Radiographic measurement of three orthogonal diameters must render a tumour estimate of ≥20 cc. 4. The treatment may be followed but not preceded by surgery, either as a salvage procedure or a neck dissection. An excision of a lymph node or tonsillectomy for diagnostic purposes, does not exclude the patient from participation. 5. WHO/ECOG performance status 0-2 6. The patient must be able to understand the information about the treatment and give a written informed consent to participate in the trial. Exclusion Criteria: 1. Previous radiotherapy in the head and neck region. 2. Concomitant or previous malignancies, except uncomplicated basal cell carcinoma, early (T1-2 N0) squamous cell carcinoma of the skin with follow-up time of at least one year for squamous cell carcinomas, and except other cancer with a disease-free follow-up of at least three years 3. Two or more synchronous primary HNSCC at time of diagnosis 4. Nasopharyngeal cancer 5. Sinonasal cancer 6. Co-existing disease prejudicing survival (expected survival \< three years). 7. Pregnancy or lactation 8. Psychiatric or addictive disorders or other medical conditions which in the view of the investigator might impair patient compliance
Where this trial is running
Gävle and 10 other locations
- Gävle Hospital — Gävle, Sweden (Not_yet_recruiting)
- Sahlgrenska University Hospital — Gothenburg, Sweden (Not_yet_recruiting)
- Jönköping Hospital — Jönköping, Sweden (Not_yet_recruiting)
- Karlstad Hospital — Karlstad, Sweden (Not_yet_recruiting)
- Linköping University hospital — Linköping, Sweden (Not_yet_recruiting)
- Lund University Hospital — Lund, Sweden (Recruiting)
- Örebro University Hospital — Örebro, Sweden (Not_yet_recruiting)
- Karolinska University Hospital — Stockholm, Sweden (Not_yet_recruiting)
- University Hospital — Umeå, Sweden (Recruiting)
- Uppsala Accademical Hospital — Uppsala, Sweden (Not_yet_recruiting)
- Västmanlands Hospital Västerås — Västerås, Sweden (Recruiting)
Study contacts
- Principal investigator: Maria Gebre-Medhin, MD — Lund University Hospital
- Study coordinator: Maria Gebre-Medhin, MD
- Email: maria.gebre-medhin@skane.se
- Phone: +46 46 17 75 20
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.