Clinical trial NCT03829033: Photon Therapy Versus Proton Therapy in Early Tonsil Cancer.
Official title: Photon Therapy Versus Proton Therapy in Early Tonsil Cancer.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tonsil Cancer
Keywords: Tonsil Cancer
Early Tonsil Cancer
Radiotherapy
Photons
Protons
Acute Side Effects
Late Side Effects
Locoregional Control
Disease Free Survival
Quality of Life
Health Economic
Lead sponsor: Lund University Hospital
Sponsor class: OTHER
First posted: 2019-02-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Acute side effects.
timeFrame: From the third week of radiotherapy, and then weekly during radiotherapy, which ends after 7 weeks.
measure: Late side effects.
timeFrame: At 2-3 months after completed radiotherapy, then every 3 month for 2 years, and then every 6 month until 5 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Gävle
country: Sweden
facility: Gävle Hospital
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Jönköping
country: Sweden
facility: Jönköping Hospital
city: Karlstad
country: Sweden
facility: Karlstad Hospital
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Lund
country: Sweden
facility: Lund University Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Umeå
country: Sweden
facility: University Hospital
city: Uppsala
country: Sweden
facility: Scandion clinic
city: Uppsala
country: Sweden
facility: Uppsala Accademical Hospital
city: Västerås
country: Sweden
facility: Västmanlands Hospital
city: Örebro
country: Sweden
facility: Örebro University Hospital
Study officials:
affiliation: Lund University Hospiyal
name: Maria Gebre-Medhin, MD
role: PRINCIPAL_INVESTIGATOR
References: