Status:
RECRUITING
Photon Therapy Versus Proton Therapy in Early Tonsil Cancer.
Lead Sponsor:
Lund University Hospital
Conditions:
Tonsil Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 C...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03829033
Start Date
January 22 2019
End Date
January 1 2028
Last Update
September 1 2021
Active Locations (12)
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1
Gävle Hospital
Gävle, Sweden, SE-803 24
2
Sahlgrenska University Hospital
Gothenburg, Sweden, SE-413 46
3
Jönköping Hospital
Jönköping, Sweden, SE-553 05
4
Karlstad Hospital
Karlstad, Sweden, SE-652 30