ARTSCAN V: Photon Therapy Versus Proton Therapy in Early Tonsil Cancer.

Sponsor

Lund University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03829033

Collaborator

(none)

100

Enrollment

Locations

Arms

107.3

Anticipated Duration (Months)

8.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tonsil Cancer	Radiation: Radiotherapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Photon Therapy Versus Proton Therapy in Early Tonsil Cancer.

Actual Study Start Date :

Jan 22, 2019

Anticipated Primary Completion Date :

Jan 1, 2028

Anticipated Study Completion Date :

Jan 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Radiotherapy delivered with photons	Radiation: Radiotherapy Radiotherapy with either photons or protons.
Experimental: Radiotherapy delivered with protons	Radiation: Radiotherapy Radiotherapy with either photons or protons.

Arm

Intervention/Treatment

Active Comparator: Radiotherapy delivered with photons

Radiation: Radiotherapy

Radiotherapy with either photons or protons.

Experimental: Radiotherapy delivered with protons

Radiation: Radiotherapy

Radiotherapy with either photons or protons.

Outcome Measures

Primary Outcome Measures

Acute side effects. [From the third week of radiotherapy, and then weekly during radiotherapy, which ends after 7 weeks.]
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
Late side effects. [At 2-3 months after completed radiotherapy, then every 3 month for 2 years, and then every 6 month until 5 years.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Gävle Hospital	Gävle	Sweden	SE-803 24
2	Sahlgrenska University Hospital	Göteborg	Sweden	SE-413 46
3	Jönköping Hospital	Jönköping	Sweden	SE-553 05
4	Karlstad Hospital	Karlstad	Sweden	SE-652 30
5	Linköping University Hospital	Linköping	Sweden	SE-587 50
6	Lund University Hospital	Lund	Sweden	SE-221 85
7	Karolinska University Hospital	Stockholm	Sweden	SE-171 64
8	University Hospital	Umeå	Sweden	SE-907 37
9	Scandion clinic	Uppsala	Sweden	SE-752 37
10	Uppsala Accademical Hospital	Uppsala	Sweden	SE-753 09
11	Västmanlands Hospital	Västerås	Sweden	SE-723 35
12	Örebro University Hospital	Örebro	Sweden	SE-703 82