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RecruitingNCT03829033ARTSCAN VUpdated Aug 27, 2026

Photon Therapy Versus Proton Therapy in Early Tonsil Cancer.

An interventional study of Radiotherapy in Tonsil Cancer, sponsored by Lund University Hospital. Recruiting at 12 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Lund University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2019; still recruiting 7 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

In this trial, patients with early squamous cell carcinoma of the tonsil with clinical stage T1-2 (p16-positive or p16-negative) N0-1 (p16-positive)/N0-N2b (p16-negative) according to American Joint Committee on Cancer (AJCC) 8th edition, aimed for unimodal and ipsilateral treatment with radiotherapy with curative intent will be included. The patients will be randomized to in a 1:1 ratio to receive radiotherapy with either photons (conventional radiotherapy) versus radiotherapy with protons.

02

Conditions studied

  • Tonsil Cancer

Keywords

  • Tonsil Cancer
  • Early Tonsil Cancer
  • Radiotherapy
  • Photons
  • Protons
  • Acute Side Effects
  • Late Side Effects
  • Locoregional Control
  • Disease Free Survival
  • Quality of Life
  • Health Economic
03

In context

Lead sponsor

Lund University Hospital is the lead sponsor of 66 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. The patient must be at least 18 years old.
  2. or cytologically confirmed, previously untreated squamous cell carcinoma of the tonsil T1-2 (p16-positive or p16-negative) N0-1 M0 (p16-positive)/N0-N2b M0 (p16-negative) according to AJCC 8th edition, aimed for unimodal and ipsilateral treatment with radiotherapy with curative intent. The treatment may be followed but not preceded by surgery, which would be as a salvage procedure and not part of the planned treatment. An excision of a lymph node, or a tonsillectomy for diagnostic purposes does not exclude the patient from participation.
  3. World Health Organisation/ (WHO/ECOG) performance status 0-1.
  4. The patient must be able to understand the information about the treatment and give a written .

Exclusion criteria

Exclusion Criteria:

  1. Patients judged to benefit from bilateral radiotherapy or concomitant chemotherapy
  2. Concomitant or previous . Exceptions are adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix uteri with a follow-up time of at least 3 years, or other previous malignancy with a disease-free interval of at least 5 years.
  3. Two or more synchronous primary cancers in the head and neck region at time of diagnosis
  4. Previous surgery or radiotherapy in the head and neck region that may affect the study result, as judged by the investigator
  5. Co-existing disease prejudicing survival (expected survival should be >2 years).
  6. Psychiatric or addictive disorders or other medical conditions which in the view of the investigator might impair patient compliance
  7. When dental fillings with amalgam or metal are present close to the tumour area it must be considered if this may affect radiotherapy before inclusion.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Radiotherapy delivered with photons

    Radiation: Radiotherapy

  • Experimental
    Radiotherapy delivered with protons

    Radiation: Radiotherapy

Interventions

  • RadiationRadiotherapy

    Radiotherapy with either photons or protons.

06

What researchers measure

Primary outcomes

  1. Acute side effects.

    Locoregional side effects (mucositis, pain, dysphagia, skin reactions and other functional impairment) are monitored weekly according to a modified morbidity scoring scale based on Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (RTOG/EORTC). Acute radiation morbidity scoring criteria and other side effects are graded according to (Common Toxicity Criteria for Adverse Events (CTCAE) v4.0

    Time frame: From the third week of radiotherapy, and then weekly during radiotherapy, which ends after 7 weeks.

  2. Late side effects.

    Locoregional side effects (mucositis, pain, dysphagia, skin reactions and other functional impairment) are monitored according to a modified morbidity scoring scale based on Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (RTOG/EORTC). Late radiation morbidity scoring criteria and other side effects are graded according to Common Toxicity Criteria for Adverse Events (CTCAE) v4.0.

    Time frame: At 2-3 months after completed radiotherapy, then every 3 month for 2 years, and then every 6 month until 5 years.

07

Study locations

12 of 12 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2019 (actual). Primary completion is estimated for Jan 2028, 108 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 1, 2019
First posted
Feb 4, 2019
StartActual
Jan 22, 2019
Primary completionEst.
Jan 2028
CompletionEst.
Jan 2028
Last update
Aug 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03829033
Lead sponsor
Lund University Hospital
Responsible party
Sponsor
First posted
Feb 4, 2019
Start date
Jan 22, 2019
Primary completion
Jan 2028 (estimated)
Completion
Jan 2028 (estimated)
Last update
Aug 27, 2026

Study contacts

Maria Gebre-Medhin, MD
Contact
maria.gebre-medhin@skane.se
+46 46 17 75 20
Iréne Schönström, RN
Contact
irene.schonstrom@skane.se
+46 46 17 85 59
Maria Gebre-Medhin, MD
principal investigator · Lund University Hospiyal

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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