Actively Recruiting
Photon Therapy Versus Proton Therapy in Early Tonsil Cancer
Led by Lund University Hospital · Updated on 2021-09-01
100
Participants Needed
12
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating treatments for patients with early squamous cell carcinoma of the tonsil, specifically those with clinical stage T1-2 and certain lymph node involvements based on p16 status. This trial compares two types of radiotherapy—using photons (conventional radiotherapy) and protons—to see how they perform when used alone and targeted to one side (ipsilateral) with curative intent. The study is sponsored by Lund University Hospital and involves random assignment to either treatment group. Participants will receive radiotherapy delivered either with photons or protons. The treatment plan involves a 7-week radiotherapy course, with patients randomized in a 1:1 ratio to one of the two radiotherapy methods. Surgery may be performed after radiotherapy only as a salvage intervention and not as part of the planned treatment, and prior diagnostic procedures such as lymph node excision or tonsillectomy do not exclude participation. During the trial, acute side effects are monitored weekly from the third week of radiotherapy until treatment completion. Late side effects are assessed starting 2 to 3 months after radiotherapy ends, continuing every 3 months for 2 years, and then every 6 months until 5 years post-treatment. Patients must be capable of giving informed consent and have a good performance status to participate, with ongoing safety and outcome evaluations conducted throughout the study period.
CONDITIONS
Brief Title
Photon Therapy Versus Proton Therapy in Early Tonsil Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be at least 18 years old
- Diagnosed with untreated squamous cell carcinoma of the tonsil T1-2 stage with specific lymph node involvement based on p16 status
- Planned for unimodal and ipsilateral radiotherapy with curative intent
- Surgery only allowed after radiotherapy as salvage treatment, not planned treatment
- WHO/ECOG performance status 0 or 1
- Able to understand treatment information and give written informed consent
You will not qualify if you...
- Patients needing bilateral radiotherapy or chemotherapy
- Current or recent other malignancies except certain treated skin or cervical cancers with sufficient disease-free time
- Two or more primary head and neck cancers at diagnosis
- Prior surgery or radiotherapy in the head and neck that may affect study results
- Co-existing serious disease with expected survival less than 2 years
- Psychiatric, addictive, or other medical conditions that could impair compliance
- Presence of dental fillings with amalgam or metal near the tumor area that may affect radiotherapy
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 weeks
Participants receive radiotherapy with either photons or protons for early tonsil cancer.
Weekly visits during radiotherapy
Duration - Up to 5 years
Participants are monitored for late side effects after completing radiotherapy.
Visits at 2-3 months post-radiotherapy, then every 3 months for 2 years, then every 6 months until 5 years
Trial Site Locations
Total: 12 locations
1
Gävle Hospital
Gävle, Sweden, SE-803 24
Actively Recruiting
2
Sahlgrenska University Hospital
Gothenburg, Sweden, SE-413 46
Actively Recruiting
3
Jönköping Hospital
Jönköping, Sweden, SE-553 05
Actively Recruiting
4
Karlstad Hospital
Karlstad, Sweden, SE-652 30
Actively Recruiting
5
Linköping University Hospital
Linköping, Sweden, SE-587 50
Actively Recruiting
6
Lund University Hospital
Lund, Sweden, SE-221 85
Actively Recruiting
7
Örebro University Hospital
Örebro, Sweden, SE-703 82
Actively Recruiting
8
Karolinska University Hospital
Stockholm, Sweden, SE-171 64
Actively Recruiting
9
University Hospital
Umeå, Sweden, SE-907 37
Actively Recruiting
10
Scandion clinic
Uppsala, Sweden, SE-752 37
Actively Recruiting
11
Uppsala Accademical Hospital
Uppsala, Sweden, SE-753 09
Actively Recruiting
12
Västmanlands Hospital
Västerås, Sweden, SE-723 35
Actively Recruiting
Research Team
M
Maria Gebre-Medhin, MD
I
Iréne Schönström, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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