<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/NCT04462042</url>
  </required_header>
  <id_info>
    <org_study_id>SWANCA</org_study_id>
    <nct_id>NCT04462042</nct_id>
  </id_info>
  <brief_title>Proton Versus Photon Therapy in Anal Squamous Cell Carcinoma</brief_title>
  <acronym>SWANCA</acronym>
  <official_title>Proton Versus Photon Therapy in Anal Squamous Cell Carcinoma - Swedish Anal Carcinoma Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Umeå University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Region Västerbotten</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Umeå University</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>
      Dosimetric studies suggest that radiotherapy with protons has a potential to reduce side&#xD;
      effects compared to treatment with photons for patients with anal carcinoma (AC). There are&#xD;
      so far no studies comparing these treatment techniques in a randomised setting. The aim of&#xD;
      this study is to compare side effects following photon therapy versus proton therapy within&#xD;
      the framework of a randomised controlled trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Anal carcinoma is a disease in which modern therapy is reasonably successful in achieving&#xD;
      tumour control/cure. Both acute and late side effects are substantial. Proton radiotherapy is&#xD;
      hypothesised to have the potential to decrease the incidence/severity of some acute side&#xD;
      effects from certain organs at risk e.g. bone marrow and intraperitoneal bowel. By sparing&#xD;
      the dose to these organs it is also possible that late effects might be less evident. Sparing&#xD;
      of the bone marrow may lead to fewer septic events and dose reductions of chemotherapy which&#xD;
      may, as a consequence, improve tumour control. The primary aim of this study is to find ways&#xD;
      to decrease acute side effects primarily to alleviate some discomfort from the patient during&#xD;
      and after a usually painful treatment experience. It has also been concluded by others that&#xD;
      reduction of acute side effects is a relevant aim and end point for the evaluation of new&#xD;
      treatment techniques and both patient reported and physician reported data are assessed&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 7, 2021</start_date>
  <completion_date type="Anticipated">March 28, 2030</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2025</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>
    <intervention_model_description>The study is an open label, multi-centre, randomised phase II study. 100 patients with anal carcinoma (including carcinoma of the perianal skin) will be randomised in 1:1 ratio to treatment delivered with photons or protons</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acute grade &gt;2 hematological side effects</measure>
    <time_frame>Treatment start until three months after treatment</time_frame>
    <description>Acute hematological side effects will be assessed by weekly full blood cell counts during radiotherapy and the first three weeks after treatment completion. Side Grade &gt;2 acute GI and haematological side-effects during therapy and up to three weeks after the end of treatment. Thereafter, every six weeks for up to three months after treatment. Results will be graded according to the Common Terminology Criteria for Adverse Events (NTCAE) v5.0 scoring system.&#xD;
Haematological adverse events will also be assessed by registering febrile episodes during an after treatment as well as the frequency of chemotherapy dose reduction or delayed chemotherapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acute grade &gt;2 gastrointestinal side effects</measure>
    <time_frame>Treatment start until three months after treatment</time_frame>
    <description>Acute side-effects from the gastrointestinal tract are assess the NTCAE v5.0 scoring system by using. Patient reported side effects are assessed by the European Organization for Research and Treatment of Cancer (EORTC), disease specific quality of life questionnaire for anal cancer, (QLQ-ANL27).&#xD;
During radiotherapy, daily reported symptoms will be investigated by a newly developed symptom scale, Radiotherapy related symptom assessment scale (RSAS). The questionnaire includes 13 items specific for current diagnose. The RSAS is a validated instrument for assessing symptom intensity and distress in patients with different cancer disease undergoing radiotherapy, with psychometric properties within the expected range. Answering categories ranges from not at all to a great deal (1-4).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute side effects from skin</measure>
    <time_frame>Treatment start until three months after treatment</time_frame>
    <description>Acute side-effects from skin are assessed by using the Common Terminology Criteria for Adverse Events (NTCAE) v5.0 scoring system. Patient reported side effects are assessed by the European Organization for Research and Treatment of Cancer (EORTC), disease specific questionnaire, QLQ-ANL27.&#xD;
During radiotherapy, daily reported symptoms will be investigated by a newly developed symptom scale, Radiotherapy related symptom assessment scale (RSAS). The questionnaire includes 13 items specific for current diagnose. The RSAS is a validated instrument for assessing symptom intensity and distress in patients with different cancer disease undergoing radiotherapy, with psychometric properties within the expected range. Answering categories ranges from not at all to a great deal (1-4).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute side effects from the genitourinary tract</measure>
    <time_frame>Treatment start until three months after treatment</time_frame>
    <description>Acute side-effects from the genitourinary tract are assessed by scoring of genitourinary symptoms, pain by using the Common Terminology Criteria for Adverse Events (NTCAE) v5.0 scoring system. Patient reported side effects are assessed by the European Organization for Research and Treatment of Cancer (EORTC), disease specific questionnaire, QLQ-ANL27.&#xD;
During radiotherapy, daily reported symptoms will be investigated by a newly developed symptom scale, Radiotherapy related symptom assessment scale (RSAS). The questionnaire includes 13 items specific for current diagnose. The RSAS is a validated instrument for assessing symptom intensity and distress in patients with different cancer disease undergoing radiotherapy, with psychometric properties within the expected range. Answering categories ranges from not at all to a great deal (1-4).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain due to acute radiation reaction</measure>
    <time_frame>Treatment start until three months after treatment</time_frame>
    <description>Pain is assessed by using the NTCAE v5.0 scoring system. Patient reported pain is assessed by the European Organization for Research and Treatment of Cancer (EORTC), disease specific questionnaire, QLQ-ANL27.&#xD;
During radiotherapy, daily reported symptoms will be investigated by a newly developed symptom scale, Radiotherapy related symptom assessment scale (RSAS). The questionnaire includes 13 items specific for current diagnose. The RSAS is a validated instrument for assessing symptom intensity and distress in patients with different cancer disease undergoing radiotherapy, with psychometric properties within the expected range. Answering categories ranges from not at all to a great deal (1-4).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Late side effects from the gastro-intestinal system</measure>
    <time_frame>From three months after treatment up to five years after treatment</time_frame>
    <description>Late side effects 1, 2 and 5 years after completion of treatment. Side effects from the gastrointestinal system, are assessed by using the NTCAE v5.0 scoring system. Patient reported side effects are assessed by the EORTCs disease specific questionnaire, QLQ-ANL27.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Late side effects</measure>
    <time_frame>From three months after treatment up to five years after treatment</time_frame>
    <description>Late side effects 1, 2 and 5 years after completion of treatment. Side effects from the genitourinary system are assessed by using the NTCAE v5.0 scoring system. Patient reported side effects are assessed by the EORTCs disease specific questionnaire, QLQ-ANL27.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Late side effects from skin</measure>
    <time_frame>From three months after treatment up to five years after treatment</time_frame>
    <description>Late side effects 1, 2 and 5 years after completion of treatment. Side effects from the skin are assessed by using the NTCAE v5.0 scoring system. Patient reported side effects are assessed by the EORTCs disease specific questionnaire, QLQ-ANL27.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Quality of life (QoL)</measure>
    <time_frame>From randomisation up to 5 years</time_frame>
    <description>Patient reported quality of life during and after treatment assessed by • HRQoL will be investigated with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire, the QLQ-C30, supplemented by the disease specific module (anal-cancer) QLQ-ANL27. • EuroQol (EQ-5D) is a generic QoL instrument designed for self-administration. The result could be expressed as a weight with values between zero and one (0-1). Together with information about survival the QoL weight can be expressed as quality-adjusted life-years (QALYs).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Primary tumour response</measure>
    <time_frame>3-6 months after treatment</time_frame>
    <description>Frequency of complete tumour regression after primary treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Locoregional failure</measure>
    <time_frame>Up to five years after randomisation</time_frame>
    <description>Time from randomisation until first recurrence, local and/or regional</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease free survival</measure>
    <time_frame>Up to five years after randomisation</time_frame>
    <description>Time from randomisation until first recurrence, local/regional/systemic or death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>Up to five years after randomisation</time_frame>
    <description>Time from randomisation until death</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cost-utility analysis</measure>
    <time_frame>From randomisation until 5 years or death</time_frame>
    <description>Costs and QoL as well as clinical outcome measured as survival time will be considered. The results of the health-economic part of the study will be expressed as cost per quality adjusted life years (QALYs) saved of one intervention in comparison with the other.&#xD;
All relevant costs should be identified, quantified, and valued. Also indirect costs related to loss of production when patients cannot work due to the disease.&#xD;
All types of resources associated with the two treatment arms during the follow-up should be considered. E.g. costs for treatment of side-effects, costs for surgery when performed, and travelling costs for patients. Costing will be performed at the end of the study.&#xD;
For evaluation and analysis of the study results, a relatively simple health-economic model will be developed. This model will be used for evaluation of the two treatment arms from inclusion into the study until 5 years of follow up or death.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Anal Cancer Squamous Cell</condition>
  <arm_group>
    <arm_group_label>Photon radiotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional photon radiation is delivered by volumetric arc therapy/intensity modulated radiotherapy/helical tomotherapy using simultaneous integrated boost (SIB) technique. The total dose to the primary tumour target and node metastases &gt;2 cm is 57.5 Gy in 27 fractions, one fraction/day, five fractions/week during 5.5 weeks. Node metastases up to 2 cm will receive 50.5 Gy in 27 fractions. Elective lymph nodes will receive a total dose of 41.6 Gy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Proton radiotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Proton radiation is delivered by spot scanning. Proton plans will be produced by single field optimisation/single field uniform dose or multifield optimisation/intensity modulated proton therapy using simultaneous integrated boost (SIB) technique. The total dose to the primary tumour target and node metastases &gt;2 cm is 57.5 Gy(RBE) in 27 fractions, one fraction/day, five fractions/week during 5.5 weeks. Node metastases up to 2 cm will receive 50.5 Gy(RBE) in 27 fractions. Elective lymph nodes will receive a total dose of 41.6 Gy(RBE).</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Proton radiotherapy</intervention_name>
    <description>Proton radiotherapy</description>
    <arm_group_label>Proton radiotherapy</arm_group_label>
    <other_name>Intensity modulated proton therapy (IMPT)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Photon radiotherapy</intervention_name>
    <description>Conventional photon radiotherapy</description>
    <arm_group_label>Photon radiotherapy</arm_group_label>
    <other_name>Volumetric arc therapy (VMAT), Intensity modulated radiotherapy (IMRT), helical tomotherapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The patient must be at least 18 years old&#xD;
&#xD;
          2. Histologically confirmed, previously untreated squamous cell carcinoma (p16-positive&#xD;
             or p16-negative) of the anal canal (ICD-O-3 C21), i.e. cancer of the perianal skin&#xD;
             without connection to the anal canal are not included. The patients may have primary&#xD;
             tumour, regional nodes, metastasis (TNM)-stage T2 (&gt;4 cm) -4,N0-1c,M0 (UICC 8th&#xD;
             edition).&#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 with cancer of the perianal skin without involvement of the anal canal&#xD;
             (ICD-O-3 C44.5) are not eligible.&#xD;
&#xD;
          2. Patient judged to have any other treatment than radiotherapy with concomitant&#xD;
             chemotherapy as the preferred treatment&#xD;
&#xD;
          3. Concomitant or previous malignancies. Exceptions are, adequately treated basal cell&#xD;
             carcinoma or squamous cell carcinoma of the skin or, other previous malignancy with a&#xD;
             disease-free interval of at least 5 years.&#xD;
&#xD;
          4. Two or more synchronous primary cancers in the pelvic region at time of diagnosis&#xD;
&#xD;
          5. Previous radiotherapy, surgery or chemotherapy that may interfere with the planned&#xD;
             treatment for the present disease, as judged by the investigator.&#xD;
&#xD;
          6. Co-existing disease prejudicing survival (expected survival should be &gt;2 years).&#xD;
&#xD;
          7. Pregnancy or breast feeding&#xD;
&#xD;
          8. When prosthetic materials (e.g. hip prostheses) are present close to the target volume&#xD;
             it must be considered if this may introduce uncertainties in dose calculations that&#xD;
             precludes especially, proton therapy.&#xD;
&#xD;
          9. Patients with pacemaker/ICD are not eligible.&#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>Björn U Zackrisson, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Umea university, Sweden</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Björn U Zackrisson, MD</last_name>
    <phone>+46907850000</phone>
    <phone_ext>51564</phone_ext>
    <email>bjorn.zackrisson@umu.se</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Martin P Nilsson, MD</last_name>
    <phone>+4640333011</phone>
    <email>martin.p.nilsson@skane.se</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Umeå university hospital</name>
      <address>
        <city>Umeå</city>
        <zip>901 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Birgitta Lindh, MD</last_name>
      <phone>+46907850000</phone>
      <phone_ext>52442</phone_ext>
      <email>birgitta.lindh@regionvasterbotten.se</email>
    </contact>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>September 28, 2021</last_update_submitted>
  <last_update_submitted_qc>September 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>proton beam therapy</keyword>
  <keyword>side effects</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Anus Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data may be made available upon request from other researchers to the study group</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 26, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT04462042/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04462042
org study id: SWANCA
nct id: NCT04462042
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Dosimetric studies suggest that radiotherapy with protons has a potential to reduce side
      effects compared to treatment with photons for patients with anal carcinoma (AC). There are
      so far no studies comparing these treatment techniques in a randomised setting. The aim of
      this study is to compare side effects following photon therapy versus proton therapy within
      the framework of a randomised controlled trial.
Anal carcinoma is a disease in which modern therapy is reasonably successful in achieving
      tumour control/cure. Both acute and late side effects are substantial. Proton radiotherapy is
      hypothesised to have the potential to decrease the incidence/severity of some acute side
      effects from certain organs at risk e.g. bone marrow and intraperitoneal bowel. By sparing
      the dose to these organs it is also possible that late effects might be less evident. Sparing
      of the bone marrow may lead to fewer septic events and dose reductions of chemotherapy which
      may, as a consequence, improve tumour control. The primary aim of this study is to find ways
      to decrease acute side effects primarily to alleviate some discomfort from the patient during
      and after a usually painful treatment experience. It has also been concluded by others that
      reduction of acute side effects is a relevant aim and end point for the evaluation of new
      treatment techniques and both patient reported and physician reported data are assessed
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The study is an open label, multi-centre, randomised phase II study. 100 patients with anal carcinoma (including carcinoma of the perianal skin) will be randomised in 1:1 ratio to treatment delivered with photons or protons
primary purpose: Treatment
masking: None (Open Label)
measure: Acute grade >2 hematological side effects
time frame: Treatment start until three months after treatment
description: Acute hematological side effects will be assessed by weekly full blood cell counts during radiotherapy and the first three weeks after treatment completion. Side Grade >2 acute GI and haematological side-effects during therapy and up to three weeks after the end of treatment. Thereafter, every six weeks for up to three months after treatment. Results will be graded according to the Common Terminology Criteria for Adverse Events (NTCAE) v5.0 scoring system.
Haematological adverse events will also be assessed by registering febrile episodes during an after treatment as well as the frequency of chemotherapy dose reduction or delayed chemotherapy.
measure: Acute grade >2 gastrointestinal side effects
time frame: Treatment start until three months after treatment
description: Acute side-effects from the gastrointestinal tract are assess the NTCAE v5.0 scoring system by using. Patient reported side effects are assessed by the European Organization for Research and Treatment of Cancer (EORTC), disease specific quality of life questionnaire for anal cancer, (QLQ-ANL27).
During radiotherapy, daily reported symptoms will be investigated by a newly developed symptom scale, Radiotherapy related symptom assessment scale (RSAS). The questionnaire includes 13 items specific for current diagnose. The RSAS is a validated instrument for assessing symptom intensity and distress in patients with different cancer disease undergoing radiotherapy, with psychometric properties within the expected range. Answering categories ranges from not at all to a great deal (1-4).
measure: Acute side effects from skin
time frame: Treatment start until three months after treatment
description: Acute side-effects from skin are assessed by using the Common Terminology Criteria for Adverse Events (NTCAE) v5.0 scoring system. Patient reported side effects are assessed by the European Organization for Research and Treatment of Cancer (EORTC), disease specific questionnaire, QLQ-ANL27.
During radiotherapy, daily reported symptoms will be investigated by a newly developed symptom scale, Radiotherapy related symptom assessment scale (RSAS). The questionnaire includes 13 items specific for current diagnose. The RSAS is a validated instrument for assessing symptom intensity and distress in patients with different cancer disease undergoing radiotherapy, with psychometric properties within the expected range. Answering categories ranges from not at all to a great deal (1-4).
measure: Acute side effects from the genitourinary tract
time frame: Treatment start until three months after treatment
description: Acute side-effects from the genitourinary tract are assessed by scoring of genitourinary symptoms, pain by using the Common Terminology Criteria for Adverse Events (NTCAE) v5.0 scoring system. Patient reported side effects are assessed by the European Organization for Research and Treatment of Cancer (EORTC), disease specific questionnaire, QLQ-ANL27.
During radiotherapy, daily reported symptoms will be investigated by a newly developed symptom scale, Radiotherapy related symptom assessment scale (RSAS). The questionnaire includes 13 items specific for current diagnose. The RSAS is a validated instrument for assessing symptom intensity and distress in patients with different cancer disease undergoing radiotherapy, with psychometric properties within the expected range. Answering categories ranges from not at all to a great deal (1-4).
measure: Pain due to acute radiation reaction
time frame: Treatment start until three months after treatment
description: Pain is assessed by using the NTCAE v5.0 scoring system. Patient reported pain is assessed by the European Organization for Research and Treatment of Cancer (EORTC), disease specific questionnaire, QLQ-ANL27.
During radiotherapy, daily reported symptoms will be investigated by a newly developed symptom scale, Radiotherapy related symptom assessment scale (RSAS). The questionnaire includes 13 items specific for current diagnose. The RSAS is a validated instrument for assessing symptom intensity and distress in patients with different cancer disease undergoing radiotherapy, with psychometric properties within the expected range. Answering categories ranges from not at all to a great deal (1-4).
measure: Late side effects from the gastro-intestinal system
time frame: From three months after treatment up to five years after treatment
description: Late side effects 1, 2 and 5 years after completion of treatment. Side effects from the gastrointestinal system, are assessed by using the NTCAE v5.0 scoring system. Patient reported side effects are assessed by the EORTCs disease specific questionnaire, QLQ-ANL27.
measure: Late side effects
time frame: From three months after treatment up to five years after treatment
description: Late side effects 1, 2 and 5 years after completion of treatment. Side effects from the genitourinary system are assessed by using the NTCAE v5.0 scoring system. Patient reported side effects are assessed by the EORTCs disease specific questionnaire, QLQ-ANL27.
measure: Late side effects from skin
time frame: From three months after treatment up to five years after treatment
description: Late side effects 1, 2 and 5 years after completion of treatment. Side effects from the skin are assessed by using the NTCAE v5.0 scoring system. Patient reported side effects are assessed by the EORTCs disease specific questionnaire, QLQ-ANL27.
measure: Assessment of Quality of life (QoL)
time frame: From randomisation up to 5 years
description: Patient reported quality of life during and after treatment assessed by • HRQoL will be investigated with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire, the QLQ-C30, supplemented by the disease specific module (anal-cancer) QLQ-ANL27. • EuroQol (EQ-5D) is a generic QoL instrument designed for self-administration. The result could be expressed as a weight with values between zero and one (0-1). Together with information about survival the QoL weight can be expressed as quality-adjusted life-years (QALYs).
measure: Primary tumour response
time frame: 3-6 months after treatment
description: Frequency of complete tumour regression after primary treatment
measure: Locoregional failure
time frame: Up to five years after randomisation
description: Time from randomisation until first recurrence, local and/or regional
measure: Disease free survival
time frame: Up to five years after randomisation
description: Time from randomisation until first recurrence, local/regional/systemic or death
measure: Overall survival
time frame: Up to five years after randomisation
description: Time from randomisation until death
measure: Cost-utility analysis
time frame: From randomisation until 5 years or death
description: Costs and QoL as well as clinical outcome measured as survival time will be considered. The results of the health-economic part of the study will be expressed as cost per quality adjusted life years (QALYs) saved of one intervention in comparison with the other.
All relevant costs should be identified, quantified, and valued. Also indirect costs related to loss of production when patients cannot work due to the disease.
All types of resources associated with the two treatment arms during the follow-up should be considered. E.g. costs for treatment of side-effects, costs for surgery when performed, and travelling costs for patients. Costing will be performed at the end of the study.
For evaluation and analysis of the study results, a relatively simple health-economic model will be developed. This model will be used for evaluation of the two treatment arms from inclusion into the study until 5 years of follow up or death.
arm group label: Photon radiotherapy
arm group type: Active Comparator
description: Conventional photon radiation is delivered by volumetric arc therapy/intensity modulated radiotherapy/helical tomotherapy using simultaneous integrated boost (SIB) technique. The total dose to the primary tumour target and node metastases >2 cm is 57.5 Gy in 27 fractions, one fraction/day, five fractions/week during 5.5 weeks. Node metastases up to 2 cm will receive 50.5 Gy in 27 fractions. Elective lymph nodes will receive a total dose of 41.6 Gy.
arm group label: Proton radiotherapy
arm group type: Experimental
description: Proton radiation is delivered by spot scanning. Proton plans will be produced by single field optimisation/single field uniform dose or multifield optimisation/intensity modulated proton therapy using simultaneous integrated boost (SIB) technique. The total dose to the primary tumour target and node metastases >2 cm is 57.5 Gy(RBE) in 27 fractions, one fraction/day, five fractions/week during 5.5 weeks. Node metastases up to 2 cm will receive 50.5 Gy(RBE) in 27 fractions. Elective lymph nodes will receive a total dose of 41.6 Gy(RBE).
intervention type: Radiation
intervention name: Proton radiotherapy
description: Proton radiotherapy
arm group label: Proton radiotherapy
other name: Intensity modulated proton therapy (IMPT)
intervention type: Radiation
intervention name: Photon radiotherapy
description: Conventional photon radiotherapy
arm group label: Photon radiotherapy
other name: Volumetric arc therapy (VMAT), Intensity modulated radiotherapy (IMRT), helical tomotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Björn U Zackrisson, Prof
role: Principal Investigator
affiliation: Umea university, Sweden
last name: Björn U Zackrisson, MD
phone: +46907850000
phone ext: 51564
email: bjorn.zackrisson@umu.se
last name: Martin P Nilsson, MD
phone: +4640333011
email: martin.p.nilsson@skane.se
facility: 
status: Recruiting
contact: 
country: Sweden
responsible party type: Sponsor
mesh term: Carcinoma, Squamous Cell
mesh term: Anus Neoplasms
sharing ipd: No
ipd description: Data may be made available upon request from other researchers to the study group
provided document: 