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

NCT06248996 | Recruiting Phase 3 DMC

• 1 other identifier: ARTSCAN VI
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Head and neck squamous cell carcinoma; radiotherapy; HNSCC; Hyperfractionated radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Conventionally fractioned (standard) group

ACTIVE COMPARATOR

This groups is treated with standard radiotherapy treatment: RT 2.0 Gy daily to final radiation dose 68.0 Gy or

Radiation: Control group

HFX-RT group

EXPERIMENTAL

Treated with Hyperfractionated radiotherapy (HFX-RT): Gy twice daily (10 fractions/week) with final dose 83.0 Gy

Radiation: Hyperfractionated radiotherpy

Interventions

Hyperfractionated radiotherpy RADIATION

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.

Also known as: HFX-RT

HFX-RT group

Control group RADIATION

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.

Also known as: standard treatment

Conventionally fractioned (standard) group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must be at least 18 years old.
• 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.
• The primary tumour must fulfil the following high-risk criteria:
• For p16+ oropharyngeal cancer: Radiographic measurement of threeorthogonal diameters must render a tumour estimate of ≥30 cc.
• For all other subsites and for p16- oropharyngeal cancer: Radiographic measurement of three orthogonal diameters must render a tumour estimate of ≥20 cc.
• 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.
• WHO/ECOG performance status 0-2
• The patient must be able to understand the information about the treatment and give a written informed consent to participate in the trial.

You may not qualify if:

• Previous radiotherapy in the head and neck region.
• 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
• Two or more synchronous primary HNSCC at time of diagnosis
• Nasopharyngeal cancer
• Sinonasal cancer
• Co-existing disease prejudicing survival (expected survival \< three years).
• Pregnancy or lactation
• Psychiatric or addictive disorders or other medical conditions which in the view of the investigator might impair patient compliance

Sponsors & Collaborators

• Lund University Hospital: lead

Study Sites (11)

Gävle Hospital

Gävle, SE-803 24, Sweden

NOT YET RECRUITING

Sahlgrenska University Hospital

Gothenburg, SE-413 46, Sweden

NOT YET RECRUITING

Jönköping Hospital

Jönköping, SE-553 05, Sweden

NOT YET RECRUITING

Karlstad Hospital

Karlstad, Sweden

NOT YET RECRUITING

Linköping University hospital

Linköping, Sweden

NOT YET RECRUITING

Lund University Hospital

Lund, SE-221 85, Sweden

RECRUITING

Örebro University Hospital

Örebro, SE-703 82, Sweden

NOT YET RECRUITING

Karolinska University Hospital

Stockholm, SE-171 64, Sweden

NOT YET RECRUITING

University Hospital

Umeå, SE-907 37, Sweden

RECRUITING

Uppsala Accademical Hospital

Uppsala, SE-753 09, Sweden

NOT YET RECRUITING

Västmanlands Hospital Västerås

Västerås, Sweden

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Maria Gebre-Medhin, MD

  Lund University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Gebre-Medhin, MD

CONTACT

+46 46 17 75 20; maria.gebre-medhin@skane.se

Ingrid Müchler

CONTACT

+46 725 96 05 10; Ingrid.Muchler@skane.se

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 8, 2024
• Study Start: March 4, 2024
• Primary Completion (Estimated): March 4, 2028
• Study Completion (Estimated): March 4, 2033
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

SE (11)