Photon Therapy Versus Proton Therapy in Early Tonsil Cancer.
ARTSCAN V
1 other identifier
interventional
100
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2019
Longer than P75 for not_applicable
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 22, 2019
CompletedFirst Submitted
Initial submission to the registry
February 1, 2019
CompletedFirst Posted
Study publicly available on registry
February 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
September 1, 2021
August 1, 2021
8.9 years
February 1, 2019
August 31, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
Study Arms (2)
Radiotherapy delivered with photons
ACTIVE COMPARATORRadiotherapy delivered with protons
EXPERIMENTALInterventions
Radiotherapy with either photons or protons.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Gävle Hospital
Gävle, SE-803 24, Sweden
Sahlgrenska University Hospital
Gothenburg, SE-413 46, Sweden
Jönköping Hospital
Jönköping, SE-553 05, Sweden
Karlstad Hospital
Karlstad, SE-652 30, Sweden
Linköping University Hospital
Linköping, SE-587 50, Sweden
Lund University Hospital
Lund, SE-221 85, Sweden
Örebro University Hospital
Örebro, SE-703 82, Sweden
Karolinska University Hospital
Stockholm, SE-171 64, Sweden
University Hospital
Umeå, SE-907 37, Sweden
Scandion clinic
Uppsala, SE-752 37, Sweden
Uppsala Accademical Hospital
Uppsala, SE-753 09, Sweden
Västmanlands Hospital
Västerås, SE-723 35, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria Gebre-Medhin, MD
Lund University Hospiyal
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2019
First Posted
February 4, 2019
Study Start
January 22, 2019
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
January 1, 2028
Last Updated
September 1, 2021
Record last verified: 2021-08