NCT03829033 Photon Therapy Versus Proton Therapy in Early Tonsil Cancer.
| NCT ID | NCT03829033 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lund University Hospital |
| Condition | Tonsil Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2019-01-22 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2019-01-22 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. The patient must be at least 18 years old. 2. 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. 3. World Health Organisation/Eastern Cooperative Oncology Group (WHO/ECOG) performance status 0-1. 4. The patient must be able to understand the information about the treatment and give a written informed consent. Exclusion Criteria: 1. Patients judged to benefit from bilateral radiotherapy or concomitant chemotherapy 2. 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. 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.
Contact & Investigator
Maria Gebre-Medhin, MD
PRINCIPAL INVESTIGATOR
Lund University Hospiyal
Frequently Asked Questions
Who can join the NCT03829033 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tonsil Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03829033 currently recruiting?
Yes, NCT03829033 is actively recruiting participants. Contact the research team at maria.gebre-medhin@skane.se for enrollment information.
Where is the NCT03829033 trial being conducted?
This trial is being conducted at Gävle, Sweden, Gothenburg, Sweden, Jönköping, Sweden, Karlstad, Sweden and 8 additional locations.
Who is sponsoring the NCT03829033 clinical trial?
NCT03829033 is sponsored by Lund University Hospital. The principal investigator is Maria Gebre-Medhin, MD at Lund University Hospiyal. The trial plans to enroll 100 participants.
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