Photon Therapy Versus Proton Therapy in Early Tonsil Cancer.

Tonsil Cancer Clinical Trial

— ARTSCAN V  

Official title:

Photon Therapy Versus Proton Therapy in Early Tonsil Cancer.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03829033
• Other study ID #: Version 2 2018-10-10
• Status: Recruiting
• Phase: N/A
• Start date: January 22, 2019
• Est. completion date: January 2028

Study information

• Verified date: August 2021
• Source: Lund University Hospital
• Contact: Maria Gebre-Medhin, MD
• Phone: +46 46 17 75 20
• Email: maria.gebre-medhin[@]skane.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2028
• Est. primary completion date: January 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tonsil Cancer

Intervention

Radiation:
• Radiotherapy
Radiotherapy with either photons or protons.

Locations

Country	Name	City	State
Sweden	Gävle Hospital	Gävle
Sweden	Sahlgrenska University Hospital	Göteborg
Sweden	Jönköping Hospital	Jönköping
Sweden	Karlstad Hospital	Karlstad
Sweden	Linköping University Hospital	Linköping
Sweden	Lund University Hospital	Lund
Sweden	Örebro University Hospital	Örebro
Sweden	Karolinska University Hospital	Stockholm
Sweden	University Hospital	Umeå
Sweden	Scandion clinic	Uppsala
Sweden	Uppsala Accademical Hospital	Uppsala
Sweden	Västmanlands Hospital	Västerås

Sponsors (1)

Lead Sponsor	Collaborator
Lund University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute side effects.	Locoregional side effects (mucositis, pain, dysphagia, skin reactions and other functional impairment) are monitored weekly according to a modified morbidity scoring scale based on Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (RTOG/EORTC). Acute radiation morbidity scoring criteria and other side effects are graded according to (Common Toxicity Criteria for Adverse Events (CTCAE) v4.0	From the third week of radiotherapy, and then weekly during radiotherapy, which ends after 7 weeks.
Primary	Late side effects.	Locoregional side effects (mucositis, pain, dysphagia, skin reactions and other functional impairment) are monitored according to a modified morbidity scoring scale based on Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (RTOG/EORTC). Late radiation morbidity scoring criteria and other side effects are graded according to Common Toxicity Criteria for Adverse Events (CTCAE) v4.0.	At 2-3 months after completed radiotherapy, then every 3 month for 2 years, and then every 6 month until 5 years.