a Multicentre Phase III Study of Risk-based Treatment Intensification With Hyperfractionated Radiotherapy in Head and Neck Cancer Patients

Head and Neck Squamous Cell Carcinoma Clinical Trial

— ARTSCAN VI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06248996
• Other study ID #: ARTSCAN VI
• Status: Recruiting
• Phase: Phase 3
• Start date: March 4, 2024
• Est. completion date: March 4, 2033

Study information

• Verified date: January 2024
• Source: Lund University Hospital
• Contact: Maria Gebre-Medhin, MD
• Phone: +46 46 17 75 20
• Email: maria.gebre-medhin[@]skane.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 308
• Est. completion date: March 4, 2033
• Est. primary completion date: March 4, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Radiation:
• Hyperfractionated radiotherpy
83.0 Gy in 68 fractions, 1.22 Gy per fraction, two daily fractions, five days per week to the primary tumour volume (GTVT_83.0). To the primary tumour with an added margin (PTVT_74.8) and to neck node metastases (PTVN_74.8) the prescribed dose will be 74.8 Gy in 68 fractions, 1.10 Gy per fraction twice daily. To elective neck nodes (PTV 54.4) the prescribed dose will be 54.4 Gy in 68 fractions, 0.80 Gy per fraction twice daily.
• Control group
68.0 Gy in 34 fractions, 2.00 Gy per fraction per day, five or six days per week to tumour volumes and 54.4 Gy in 34 fractions, 1.60 Gy per fraction to elective neck nodes.

Locations

Country	Name	City	State
Sweden	Gävle Hospital	Gävle
Sweden	Sahlgrenska University Hospital	Göteborg
Sweden	Jönköping Hospital	Jönköping
Sweden	Karlstad Hospital	Karlstad
Sweden	Linköping University hospital	Linköping
Sweden	Lund University Hospital	Lund
Sweden	Örebro University Hospital	Örebro
Sweden	Karolinska University Hospital	Stockholm
Sweden	University Hospital	Umeå
Sweden	Uppsala Accademical Hospital	Uppsala
Sweden	Västmanlands Hospital Västerås	Västerås

Sponsors (1)

Lead Sponsor	Collaborator
Lund University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local tumour control after treatment	Local tumour control after treatment with conventionally fractionated (standard) RT compared with hyperfractionated radiotherapy (HFX-RT)	Every three months for two years, then every 6 moths up to 5 years