Comparing Photon and Proton Therapy for Early Tonsil Cancer
Photon Therapy Versus Proton Therapy in Early Tonsil Cancer.
This study is testing whether proton therapy works better than photon therapy for treating early-stage tonsil cancer in patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Lund University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 12 sites (Gävle and 11 other locations) |
| Trial ID | NCT03829033 on ClinicalTrials.gov |
What this trial studies
This trial involves patients with early-stage squamous cell carcinoma of the tonsil who will be randomized to receive either photon or proton radiotherapy as a treatment option. The study focuses on patients with specific clinical stages of tonsil cancer, aiming for a curative approach with unimodal and ipsilateral treatment. Participants will be monitored for treatment outcomes to determine the effectiveness of each radiotherapy method.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with untreated early-stage squamous cell carcinoma of the tonsil.
Not a fit: Patients who require bilateral radiotherapy or concomitant chemotherapy, or those with previous malignancies, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into which radiotherapy method is more effective for treating early tonsil cancer, potentially improving patient outcomes.
How similar studies have performed: While there have been studies comparing different radiotherapy techniques, this specific comparison of photon versus proton therapy in early tonsil cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Gävle and 11 other locations
- Gävle Hospital — Gävle, Sweden (Recruiting)
- Sahlgrenska University Hospital — Gothenburg, Sweden (Recruiting)
- Jönköping Hospital — Jönköping, Sweden (Recruiting)
- Karlstad Hospital — Karlstad, Sweden (Recruiting)
- Linköping University Hospital — Linköping, Sweden (Recruiting)
- Lund University Hospital — Lund, Sweden (Recruiting)
- Örebro University Hospital — Örebro, Sweden (Recruiting)
- Karolinska University Hospital — Stockholm, Sweden (Recruiting)
- University Hospital — Umeå, Sweden (Recruiting)
- Scandion clinic — Uppsala, Sweden (Recruiting)
- Uppsala Accademical Hospital — Uppsala, Sweden (Recruiting)
- Västmanlands Hospital — Västerås, Sweden (Recruiting)
Study contacts
- Principal investigator: Maria Gebre-Medhin, MD — Lund University Hospiyal
- Study coordinator: Maria Gebre-Medhin, MD
- Email: maria.gebre-medhin@skane.se
- Phone: +46 46 17 75 20
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.