RecruitingNot ApplicableNCT03829033
Photon Therapy Versus Proton Therapy in Early Tonsil Cancer.
Sponsor
Lund University Hospital
Enrollment
100 participants
Start Date
Jan 22, 2019
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria4
- 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.
Exclusion Criteria7
- 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.
Interventions
RADIATIONRadiotherapy
Radiotherapy with either photons or protons.
Locations(12)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03829033
Related Trials
ctHPVDNA in HPV Positive Squamous Cell Carcinoma of the Oropharynx
NCT069150382 locations
Treatment De-Escalation for Favorable Prognosis Human Papilloma Virus (HPV) or p16-Positive Oropharyngeal Cancer Receiving Definitive Radiotherapy
NCT069026232 locations
Neoadjuvant Chemotherapy and Transoral Robotic Surgery for Oropharyngeal Cancer.
NCT042778581 location