Tonsil CancerARTSCAN VNCT03829033
Photon Therapy Versus Proton Therapy in Early Tonsil Cancer.
A study testing Radiotherapy in people with Tonsil Cancer, run by Lund University Hospital at 12 sites in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tonsil Cancer
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 12 sitesSweden
- Study dates
- 22 Jan 2019to Jan 2028
- Phase
- Interventional
- 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 years and older
- 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 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.
- World Health Organisation/Eastern Cooperative Oncology Group (WHO/ECOG) performance status 0-1.
- The patient must be able to understand the information about the treatment and give a written informed consent.
Who cannot join
- Patients judged to benefit from bilateral radiotherapy or concomitant chemotherapy
- Concomitant or previous malignancies. 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.
- Two or more synchronous primary cancers in the head and neck region at time of diagnosis
- Previous surgery or radiotherapy in the head and neck region that may affect the study result, as judged by the investigator
- Co-existing disease prejudicing survival (expected survival should be >2 years).
- Psychiatric or addictive disorders or other medical conditions which in the view of the investigator might impair patient compliance
- 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.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
Sweden12 sites, 12 recruiting
- 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
- Recruiting
Sahlgrenska University Hospital
Gothenburg, SE-413 46
Hedda Haugen, MD, +46 31 343 60 42, hedda.haugen@oncology.gu.se
Hedda Haugen, MD
- Recruiting
Jönköping Hospital
Jönköping, SE-553 05
Mattias Olin, MD, +46 10 24 25 942, mattias.olin@rjl.se
Mattias Olin, MD
- Recruiting
Karlstad Hospital
Karlstad, SE-652 30
Britta Lödén, MD, +46 54 61 50 00, britta.loden@regionvarmland.se
Britta Lödén, MD
- Recruiting
Linköping University Hospital
Linköping, SE-587 50
Anna Flejmer, MD, +46 10 103 00 00, anna.maria.flejmer@regionostergotland.se
Anna Flejmer, MD
- 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
- Recruiting
Karolinska University Hospital
Stockholm, SE-171 64
Michael Gubanski, MD, +46 8 517 700 00, michael.gubanski@sll.se
Michael Gubanski, MD
- Recruiting
University Hospital
Umeå, SE-907 37
Björn Zackrisson, MD, +46 90 785 00 00, bjorn.zackrisson@onkologi.umu.se
Björn Zackrisson, MD
- Recruiting
Scandion clinic
Uppsala, SE-752 37
Johanna Färlin, MD, +46 18 495 80 00, johanna.farlin@skandion.se
Johanna Färlin, 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
- Recruiting
Västmanlands Hospital
Västerås, SE-723 35
Zizana Lovasova, MD, +46 21 17 39 04, zuzana.lovasova@regionvastmanland.se
Zuzana Lovasova, MD
About this study
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.
- Conditions
- Tonsil Cancer
- Being tested
- Radiotherapy
- 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
- Medical subject headings
- Tonsillar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Radiotherapy with either photons or protons.
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy delivered with photons | Active comparator | Not described Receives: Radiation: Radiotherapy |
| Radiotherapy delivered with protons | Experimental | Not described Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From the third week of radiotherapy, and then weekly during radiotherapy, which ends after 7 weeks.
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.
Measured: At 2-3 months after completed radiotherapy, then every 3 month for 2 years, and then every 6 month until 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start22 Jan 2019
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tonsil CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Gebre-Medhin, MD, Principal investigator, Lund University Hospiyal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03829033
- Sponsor's protocol ID
- Version 2 2018-10-10
- Acronym
- ARTSCAN V
- Status last verified
- Aug 2026
- First submitted
- 1 Feb 2019
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photon Therapy Versus Proton Therapy in Early Tonsil Cancer.
- ClinicalTrials.gov ID
- NCT03829033
- Acronym / sponsor ID
- ARTSCAN V / Version 2 2018-10-10
- Conditions
- Tonsil Cancer
- Keywords
- Tonsil Cancer, Early Tonsil Cancer, Radiotherapy, Photons, Protons, Acute Side Effects, Late Side Effects, Locoregional Control
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Study start
- 22 Jan 2019 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 4 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy delivered with photons | Active comparator | Radiation: Radiotherapy |
| Radiotherapy delivered with protons | Experimental | Radiation: Radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient must be at least 18 years old.
- Histologically 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.
- World Health Organisation/Eastern Cooperative Oncology Group (WHO/ECOG) performance status 0-1.
- The patient must be able to understand the information about the treatment and give a written informed consent.
Key exclusion criteria (7 listed)
- Patients judged to benefit from bilateral radiotherapy or concomitant chemotherapy
- Concomitant or previous malignancies. 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.
- Two or more synchronous primary cancers in the head and neck region at time of diagnosis
- Previous surgery or radiotherapy in the head and neck region that may affect the study result, as judged by the investigator
- Co-existing disease prejudicing survival (expected survival should be >2 years).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiotherapyRadiotherapy with either photons or protons. | Radiation | Radiotherapy delivered with photons, Radiotherapy delivered with protons |
Primary outcome
Acute side effects.
Time frame: From the third week of radiotherapy, and then weekly during radiotherapy, which ends after 7 weeks.
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
Late side effects.
Time frame: At 2-3 months after completed radiotherapy, then every 3 month for 2 years, and then every 6 month until 5 years.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Gebre-Medhin, MD principal investigator
Lund University Hospiyal
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiotherapy in people with Tonsil Cancer, run by Lund University Hospital at 12 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 4 inclusion and 7 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 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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.
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?
Acute side effects. (time frame: From the third week of radiotherapy, and then weekly during radiotherapy, which ends after 7 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2026.