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Head and Neck Squamous Cell CarcinomaPhase 3ARTSCAN VINCT06248996

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

A Phase 3 study testing Hyperfractionated radiotherpy in people with Head and Neck Squamous Cell Carcinoma, run by Lund University Hospital at 11 sites in Sweden.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Head and Neck Squamous Cell Carcinoma
What is being tested?
Hyperfractionated radiotherpy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
308 participants
Where
11 sitesSweden
Study dates
4 Mar 2024to 4 Mar 2033
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

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

11 sites in 1 country

Sweden11 sites, 11 recruiting

  • Gävle Hospital

    Gävle, SE-803 24

    Ann-Sofie Fransson, MD, +46 26 15 40 00, ann-sofie.fransson@regiongavleborg.se

    Ann-Sofie Fransson, MD

    Not yet recruiting

  • Sahlgrenska University Hospital

    Gothenburg, SE-413 46

    Hedda Haugen, MD, +46 31 343 60 42, hedda.haugen@oncology.gu.se

    Hedda Haugen, MD

    Not yet recruiting

  • Jönköping Hospital

    Jönköping, SE-553 05

    Mattias Olin, MD, +46 10 24 25 942, mattias.olin@rjl.se

    Mattias Olin, MD

    Not yet recruiting

  • Karlstad Hospital

    Karlstad

    Björn Kullinger, MD

    Björn Kullinger, MD

    Not yet recruiting

  • Linköping University hospital

    Linköping

    Jan Rzepecki, MD

    Jan Rzepecki, MD

    Not yet recruiting

  • Lund University Hospital

    Lund, SE-221 85

    Maria Gebre-Medhin, MD, +46 46 17 75 20, maria.gebre-medhin@skane.se

    Maria Gebre-Medhin, MD

    Recruiting

  • Örebro University Hospital

    Örebro, SE-703 82

    Erik Lundin, MD, +46 19 602 10 00, erik.lundin@regionorebrolan.se

    Erik Lundin, MD

    Not yet recruiting

  • Karolinska University Hospital

    Stockholm, SE-171 64

    Michael Gubanski, MD, +46 8 517 700 00, michael.gubanski@sll.se

    Michael Gubanski, MD

    Not yet recruiting

  • University Hospital

    Umeå, SE-907 37

    Björn Zackrisson, MD, +46 90 785 00 00, bjorn.zackrisson@onkologi.umu.se

    Björn Zackrisson, MD

    Recruiting

  • Uppsala Accademical Hospital

    Uppsala, SE-753 09

    Zahra Taheri Kadkhoda, MD, +46 18 611 00 00, zahra.taheri.kadkhoda@akademiska.se

    Zahra Taheri Kadkhoda, MD

    Not yet recruiting

  • Västmanlands Hospital Västerås

    Västerås

    Zuzana Lovasova, MD

    Zuzana Lovasova, MD

    Recruiting

Other trials in Sweden

About this study

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

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.

Being tested
Hyperfractionated radiotherpy, Control group
Keywords
Head and neck squamous cell carcinoma, radiotherapy, HNSCC, Hyperfractionated radiotherapy
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hyperfractionated radiotherpyRadiation

    Also called HFX-RT

    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 groupRadiation

    Also called standard treatment

    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.

Study groups in NCT06248996
Study groupRoleWhat they receive
Conventionally fractioned (standard) groupActive comparatorThis groups is treated with standard radiotherapy treatment: RT 2.0 Gy daily to final radiation dose 68.0 Gy or
Receives: Radiation: Control group
HFX-RT groupExperimentalTreated with Hyperfractionated radiotherapy (HFX-RT): Gy twice daily (10 fractions/week) with final dose 83.0 Gy
Receives: Radiation: Hyperfractionated radiotherpy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Local tumour control after treatment

    Local tumour control after treatment with conventionally fractionated (standard) RT compared with hyperfractionated radiotherapy (HFX-RT)

    Measured: Every three months for two years, then every 6 moths up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2024
  2. Study start4 Mar 2024
  3. Primary completion4 Mar 2028 (estimated)
  4. Study completion4 Mar 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
308 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06248996
Sponsor's protocol ID
ARTSCAN VI
Acronym
ARTSCAN VI
Status last verified
Sep 2024
First submitted
31 Jan 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Hyperfractionated radiotherpy in people with Head and Neck Squamous Cell Carcinoma, run by Lund University Hospital at 11 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maria Gebre-Medhin, MD (+46 46 17 75 20, maria.gebre-medhin@skane.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local tumour control after treatment (time frame: Every three months for two years, then every 6 moths up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06248996.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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