<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03829033</url>
  </required_header>
  <id_info>
    <org_study_id>Version 2 2018-10-10</org_study_id>
    <nct_id>NCT03829033</nct_id>
  </id_info>
  <brief_title>Photon Therapy Versus Proton Therapy in Early Tonsil Cancer.</brief_title>
  <acronym>ARTSCAN V</acronym>
  <official_title>Photon Therapy Versus Proton Therapy in Early Tonsil Cancer.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lund University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lund University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this trial, patients with early squamous cell carcinoma of the tonsil with clinical stage&#xD;
      T1-2 (p16-positive or p16-negative) N0-1 (p16-positive)/N0-N2b (p16-negative) according to&#xD;
      American Joint Committee on Cancer (AJCC) 8th edition, aimed for unimodal and ipsilateral&#xD;
      treatment with radiotherapy with curative intent will be included. The patients will be&#xD;
      randomized to in a 1:1 ratio to receive radiotherapy with either photons (conventional&#xD;
      radiotherapy) versus radiotherapy with protons.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 22, 2019</start_date>
  <completion_date type="Anticipated">January 2028</completion_date>
  <primary_completion_date type="Anticipated">January 2028</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acute side effects.</measure>
    <time_frame>From the third week of radiotherapy, and then weekly during radiotherapy, which ends after 7 weeks.</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Late side effects.</measure>
    <time_frame>At 2-3 months after completed radiotherapy, then every 3 month for 2 years, and then every 6 month until 5 years.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Tonsil Cancer</condition>
  <arm_group>
    <arm_group_label>Radiotherapy delivered with photons</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Radiotherapy delivered with protons</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiotherapy</intervention_name>
    <description>Radiotherapy with either photons or protons.</description>
    <arm_group_label>Radiotherapy delivered with photons</arm_group_label>
    <arm_group_label>Radiotherapy delivered with protons</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The patient must be at least 18 years old.&#xD;
&#xD;
          2. Histologically or cytologically confirmed, previously untreated squamous cell&#xD;
             carcinoma of the tonsil T1-2 (p16-positive or p16-negative) N0-1 M0&#xD;
             (p16-positive)/N0-N2b M0 (p16-negative) according to AJCC 8th edition, aimed for&#xD;
             unimodal and ipsilateral treatment with radiotherapy with curative intent. The&#xD;
             treatment may be followed but not preceded by surgery, which would be as a salvage&#xD;
             procedure and not part of the planned treatment. An excision of a lymph node, or a&#xD;
             tonsillectomy for diagnostic purposes does not exclude the patient from participation.&#xD;
&#xD;
          3. World Health Organisation/Eastern Cooperative Oncology Group (WHO/ECOG) performance&#xD;
             status 0-1.&#xD;
&#xD;
          4. The patient must be able to understand the information about the treatment and give a&#xD;
             written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients judged to benefit from bilateral radiotherapy or concomitant chemotherapy&#xD;
&#xD;
          2. Concomitant or previous malignancies. Exceptions are adequately treated basal cell&#xD;
             carcinoma or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix&#xD;
             uteri with a follow-up time of at least 3 years, or other previous malignancy with a&#xD;
             disease-free interval of at least 5 years.&#xD;
&#xD;
          3. Two or more synchronous primary cancers in the head and neck region at time of&#xD;
             diagnosis&#xD;
&#xD;
          4. Previous surgery or radiotherapy in the head and neck region that may affect the study&#xD;
             result, as judged by the investigator&#xD;
&#xD;
          5. Co-existing disease prejudicing survival (expected survival should be &gt;2 years).&#xD;
&#xD;
          6. Psychiatric or addictive disorders or other medical conditions which in the view of&#xD;
             the investigator might impair patient compliance&#xD;
&#xD;
          7. When dental fillings with amalgam or metal are present close to the tumour area it&#xD;
             must be considered if this may affect radiotherapy before inclusion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria Gebre-Medhin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lund University Hospiyal</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Maria Gebre-Medhin, MD</last_name>
    <phone>+46 46 17 75 20</phone>
    <email>maria.gebre-medhin@skane.se</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Iréne Schönström, RN</last_name>
    <phone>+46 46 17 85 59</phone>
    <email>irene.schonstrom@skane.se</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Gävle Hospital</name>
      <address>
        <city>Gävle</city>
        <zip>SE-803 24</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ann-Sofie Fransson, MD</last_name>
      <phone>+46 26 15 40 00</phone>
      <email>ann-sofie.fransson@regiongavleborg.se</email>
    </contact>
    <investigator>
      <last_name>Ann-Sofie Fransson, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sahlgrenska University Hospital</name>
      <address>
        <city>Göteborg</city>
        <zip>SE-413 46</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hedda Haugen, MD</last_name>
      <phone>+46 31 343 60 42</phone>
      <email>hedda.haugen@oncology.gu.se</email>
    </contact>
    <investigator>
      <last_name>Hedda Haugen, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Jönköping Hospital</name>
      <address>
        <city>Jönköping</city>
        <zip>SE-553 05</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mattias Olin, MD</last_name>
      <phone>+46 10 24 25 942</phone>
      <email>mattias.olin@rjl.se</email>
    </contact>
    <investigator>
      <last_name>Mattias Olin, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Karlstad Hospital</name>
      <address>
        <city>Karlstad</city>
        <zip>SE-652 30</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Britta Lödén, MD</last_name>
      <phone>+46 54 61 50 00</phone>
      <email>britta.loden@regionvarmland.se</email>
    </contact>
    <investigator>
      <last_name>Britta Lödén, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Linköping University Hospital</name>
      <address>
        <city>Linköping</city>
        <zip>SE-587 50</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anna Flejmer, MD</last_name>
      <phone>+46 10 103 00 00</phone>
      <email>anna.maria.flejmer@regionostergotland.se</email>
    </contact>
    <investigator>
      <last_name>Anna Flejmer, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Lund University Hospital</name>
      <address>
        <city>Lund</city>
        <zip>SE-221 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Gebre-Medhin, MD</last_name>
      <phone>+46 46 17 75 20</phone>
      <email>maria.gebre-medhin@skane.se</email>
    </contact>
    <investigator>
      <last_name>Maria Gebre-Medhin, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Karolinska University Hospital</name>
      <address>
        <city>Stockholm</city>
        <zip>SE-171 64</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Gubanski, MD</last_name>
      <phone>+46 8 517 700 00</phone>
      <email>michael.gubanski@sll.se</email>
    </contact>
    <investigator>
      <last_name>Michael Gubanski, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Umeå</city>
        <zip>SE-907 37</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Björn Zackrisson, MD</last_name>
      <phone>+46 90 785 00 00</phone>
      <email>bjorn.zackrisson@onkologi.umu.se</email>
    </contact>
    <investigator>
      <last_name>Björn Zackrisson, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Scandion clinic</name>
      <address>
        <city>Uppsala</city>
        <zip>SE-752 37</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Johanna Färlin, MD</last_name>
      <phone>+46 18 495 80 00</phone>
      <email>johanna.farlin@skandion.se</email>
    </contact>
    <investigator>
      <last_name>Johanna Färlin, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Uppsala Accademical Hospital</name>
      <address>
        <city>Uppsala</city>
        <zip>SE-753 09</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zahra Taheri Kadkhoda, MD</last_name>
      <phone>+46 18 611 00 00</phone>
      <email>zahra.taheri.kadkhoda@akademiska.se</email>
    </contact>
    <investigator>
      <last_name>Zahra Taheri Kadkhoda, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Västmanlands Hospital</name>
      <address>
        <city>Västerås</city>
        <zip>SE-723 35</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zizana Lovasova, MD</last_name>
      <phone>+46 21 17 39 04</phone>
      <email>zuzana.lovasova@regionvastmanland.se</email>
    </contact>
    <investigator>
      <last_name>Zuzana Lovasova, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Örebro University Hospital</name>
      <address>
        <city>Örebro</city>
        <zip>SE-703 82</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Erik Lundin, MD</last_name>
      <phone>+46 19 602 10 00</phone>
      <email>erik.lundin@regionorebrolan.se</email>
    </contact>
    <investigator>
      <last_name>Erik Lundin, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>August 31, 2021</last_update_submitted>
  <last_update_submitted_qc>August 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tonsil Cancer</keyword>
  <keyword>Early Tonsil Cancer</keyword>
  <keyword>Radiotherapy</keyword>
  <keyword>Photons</keyword>
  <keyword>Protons</keyword>
  <keyword>Acute Side Effects</keyword>
  <keyword>Late Side Effects</keyword>
  <keyword>Locoregional Control</keyword>
  <keyword>Disease Free Survival</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Health Economic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tonsillar Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03829033
org study id: Version 2 2018-10-10
nct id: NCT03829033
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Acute side effects.
time frame: From the third week of radiotherapy, and then weekly during radiotherapy, which ends after 7 weeks.
description: 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
measure: Late side effects.
time frame: At 2-3 months after completed radiotherapy, then every 3 month for 2 years, and then every 6 month until 5 years.
description: 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.
arm group label: Radiotherapy delivered with photons
arm group type: Active Comparator
arm group label: Radiotherapy delivered with protons
arm group type: Experimental
intervention type: Radiation
intervention name: Radiotherapy
description: Radiotherapy with either photons or protons.
arm group label: Radiotherapy delivered with photons
arm group label: Radiotherapy delivered with protons
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Maria Gebre-Medhin, MD
role: Principal Investigator
affiliation: Lund University Hospiyal
last name: Maria Gebre-Medhin, MD
phone: +46 46 17 75 20
email: maria.gebre-medhin@skane.se
last name: Iréne Schönström, RN
phone: +46 46 17 85 59
email: irene.schonstrom@skane.se
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Sweden
responsible party type: Sponsor
mesh term: Tonsillar Neoplasms