<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/NCT04424628</url>
  </required_header>
  <id_info>
    <org_study_id>GEN-RAD-2019-01</org_study_id>
    <nct_id>NCT04424628</nct_id>
  </id_info>
  <brief_title>Radiotherapy 3 vs 6 Gy in Gonarthrosis and Coxarthrosis</brief_title>
  <acronym>RAGOCO</acronym>
  <official_title>Three vs Six Gy in Gonarthrosis and Coxarthrosis. Non Inferiority Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundacion GenesisCare</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Elekta Limited</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundacion GenesisCare</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>
      This is a non-inferiority study in which the investigators compare two low-dose radiotherapy&#xD;
      schemes, which are recommended from DEGRO Clinical Practice Guidelines (3 Gy vs 6 Gy) for the&#xD;
      treatment of osteoarthritis and other osteodegenerative disorders.&#xD;
&#xD;
      A first randomization will be carried out among the patients included in the study:&#xD;
&#xD;
        -  Patients in arm A will be treated at 3 Gy (0.5 Gy/fraction, 3 fractions/week), and&#xD;
           patients in arm B will be treated at 6 Gy (1 Gy/fraction, 3 fractions/week).&#xD;
&#xD;
        -  Patients should not know the arm to which they have been randomized.&#xD;
&#xD;
        -  Once the treatment is finished, patients will be assessed at 8 weeks. If pain does not&#xD;
           improve, a re-irradiation will be performed. If the patients were treated with 3 Gy a&#xD;
           new randomization will be performed (3 vs 6 Gy again). If the patiens were treated with&#xD;
           6 Gy they will be re-irradiated with 6 Gy again.&#xD;
&#xD;
      The investigators will analyze the results obtained depending on the dose received and&#xD;
      depending on the location of the treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Painfull skeletal disorders are susceptible to be treated with low-dose radiotherapy. DEGRO&#xD;
      guidelines recommend a dose between 3 and 6 Gy at 0'5 Gy/fraction or 1 Gy/fraction&#xD;
      respectively. The investigators want to verify that both treatments (3 and 6 Gy) are similar&#xD;
      to improve the pain and function in patiens with gonarthrosis and coxarthrosis, and there are&#xD;
      no differences between both treatments, therefore, 3 Gy is not less than 6 Gy.&#xD;
&#xD;
      In this context, a prospective multicenter study is proposed. The study will include 338&#xD;
      patients to assess the efficacy of low dose irradiation (3 vs 6 Gy) in gonarthrosis and&#xD;
      coxarthrosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Anticipated">April 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2021</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>Arm 1: 3 Gy (repeated at 8 weeks if necessary. New ramdomization to 3 Gy or 6 Gy) Arm 2: 6 Gy (repeated at 8 weeks if necessry)</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Patients label</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pain control at 8-12 weeks and every 6 months</measure>
    <time_frame>At 8-12 weeks, 6 months, 12 months, 18 months and 24 months</time_frame>
    <description>To evaluate the non inferiority efficacy of low dose radiotherapy 3 or 6 Gy to change in pain with VAS (Visual Analogue Scale). The patient scores his painfrom 0 (no hurt) to 10 (hurts worst). It is better a low score.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Life at 8-12 weeks and every 6 months</measure>
    <time_frame>At 8-12 weeks, 6 months, 12 months, 18 months and 24 months</time_frame>
    <description>To evaluate the non inferiority efficacy of low dose radiotherapy 3 or 6 Gy to change in pain with WOMAC scale (Western Ontario MacMaster Questionnaire). This questionnaire has 24 questions about pain, joint stiffness and joint function. It is better a low score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Skin toxicity at 8-12 weeks.</measure>
    <time_frame>At 8-12 weeks.</time_frame>
    <description>Skin toxicity will be assessed and rated acording to the RTOG scale (0= no change over baseline; 1: Follicular, faint or dull erythema epilation, dry desquamation, decreased sweating; 2: Tender or bright erythema, patchy moist desquamation, moderate oedema; 3: Confluent, moist desquamation other tan skin folds, pitting oedema; 4: Ulceration haemorrhege, necrosis.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">338</enrollment>
  <condition>Gonarthrosis</condition>
  <condition>Coxarthrosis</condition>
  <arm_group>
    <arm_group_label>Radiotherapy 3 Gy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patiens will receive low dose gonarthrosis or coxarthrosis radiotherapy (0.5 Gy in 6 fractions alternating days).&#xD;
Evaluation of pain releave and quality of live in 8-12 weeks If no effect the patient will be randomized to 3 or 6 Gy again</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Radiotherapy 6 Gy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patiens will receive low dose gonarthrosis or coxarthrosis radiotherapy (1 Gy in 6 fractions alternating days).&#xD;
Evaluation of pain releave and quality of live in 8-12 weeks If no effect the patient will be treated with 6 Gy again</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Low dose radiotherapy A</intervention_name>
    <description>Low dose radiotherapy was 0.5 Gy in 6 fractions. Evaluation of pain and Quality of Life in 8-12 weeks. If no pain releave the patient is randomized to 3 or 6 Gy again</description>
    <arm_group_label>Radiotherapy 3 Gy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Low dose radiotherapy B</intervention_name>
    <description>Low dose radiotherapy was 0.5 Gy in 6 fractions. Evaluation of pain and Quality of Life in 8-12 weeks. If no pain releave the patient is treated with 6 Gy again</description>
    <arm_group_label>Radiotherapy 6 Gy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;50 years&#xD;
&#xD;
          -  Gonarthrosis or/and Coxarthrosis diagnose&#xD;
&#xD;
          -  At least 1 year of evolution&#xD;
&#xD;
          -  Non response to drug or surgery treatments&#xD;
&#xD;
          -  Risk of colateral side effects due to the comorbidity of the patient with conventional&#xD;
             treatments.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous high dose radiotherapy in the same location&#xD;
&#xD;
          -  Conective tissue disease (LUPUS, reumathoid artritis, esclerodermia, Sd. Raynaud, Sd.&#xD;
             Sjögren, polymiositis)&#xD;
&#xD;
          -  Inherited Hipersesitivity Sindromes (ataxia-telangiectasia, Fanconi's anaemya, Sd.&#xD;
             Nijmegen, Sd. Gorlyn, Sd. Cockayne, Sd. Down, Sd. Gardner, Sd. Usher)&#xD;
&#xD;
          -  No follow up possibility&#xD;
&#xD;
          -  Other study inclusion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Rivas Sanchez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fundacion GenesisCare</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Daniel Rivas Sanchez, MD</last_name>
    <phone>+34951569589</phone>
    <email>daniel.rivas@genesiscare.es</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Raul Hernaz, MD</last_name>
    <phone>+34915644383</phone>
    <email>raul.hernanz@genesiscare.es</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>GenesisCare Malaga</name>
      <address>
        <city>Malaga</city>
        <zip>29018</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniel Rivas Sanchez, MD</last_name>
      <phone>+34951569589</phone>
      <email>daniel.rivas@genesiscare.es</email>
    </contact>
    <contact_backup>
      <last_name>Raul Hernanz, MD</last_name>
      <phone>+34915644383</phone>
      <email>raul.hernanz@genesiscare.es</email>
    </contact_backup>
    <investigator>
      <last_name>Daniel Rivas Sanchez, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Micke O, Seegenschmiedt MH; German Working Group on Radiotherapy in Germany. Consensus guidelines for radiation therapy of benign diseases: a multicenter approach in Germany. Int J Radiat Oncol Biol Phys. 2002 Feb 1;52(2):496-513. doi: 10.1016/s0360-3016(01)01814-4.</citation>
    <PMID>11872298</PMID>
  </reference>
  <reference>
    <citation>Montero Luis A, Hernanz de Lucas R, Hervas Moron A, Fernandez Lizarbe E, Sancho Garcia S, Vallejo Ocana C, Polo Rubio A, Ramos Aguerri A. Radiation therapy for the treatment of benign vascular, skeletal and soft tissue diseases. Clin Transl Oncol. 2008 Jun;10(6):334-46. doi: 10.1007/s12094-008-0209-6.</citation>
    <PMID>18558580</PMID>
  </reference>
  <reference>
    <citation>Reichl B, Block A, Schafer U, Bert C, Muller R, Jung H, Rodel F; German Cooperative Group on Radiotherapy for Benign Diseases (GCG-BD). DEGRO practical guidelines for radiotherapy of non-malignant disorders: Part I: physical principles, radiobiological mechanisms, and radiogenic risk. Strahlenther Onkol. 2015 Sep;191(9):701-9. doi: 10.1007/s00066-015-0865-8. Epub 2015 Jun 28.</citation>
    <PMID>26117368</PMID>
  </reference>
  <reference>
    <citation>Smith-Bindman R, Lipson J, Marcus R, Kim KP, Mahesh M, Gould R, Berrington de Gonzalez A, Miglioretti DL. Radiation dose associated with common computed tomography examinations and the associated lifetime attributable risk of cancer. Arch Intern Med. 2009 Dec 14;169(22):2078-86. doi: 10.1001/archinternmed.2009.427.</citation>
    <PMID>20008690</PMID>
  </reference>
  <reference>
    <citation>Jansen JT, Broerse JJ, Zoetelief J, Klein C, Seegenschmiedt HM. Estimation of the carcinogenic risk of radiotherapy of benign diseases from shoulder to heel. Radiother Oncol. 2005 Sep;76(3):270-7. doi: 10.1016/j.radonc.2005.06.034.</citation>
    <PMID>16157402</PMID>
  </reference>
  <reference>
    <citation>Minten MJM, Leseman-Hoogenboom MM, Kloppenburg M, Kortekaas MC, Leer JW, Poortmans PMP, van den Hoogen FHJ, den Broeder AA, van den Ende CHM. Lack of beneficial effects of low-dose radiation therapy on hand osteoarthritis symptoms and inflammation: a randomised, blinded, sham-controlled trial. Osteoarthritis Cartilage. 2018 Oct;26(10):1283-1290. doi: 10.1016/j.joca.2018.06.010. Epub 2018 Jul 7.</citation>
    <PMID>30231990</PMID>
  </reference>
  <reference>
    <citation>Arenas M, Sabater S, Hernandez V, Rovirosa A, Lara PC, Biete A, Panes J. Anti-inflammatory effects of low-dose radiotherapy. Indications, dose, and radiobiological mechanisms involved. Strahlenther Onkol. 2012 Nov;188(11):975-81. doi: 10.1007/s00066-012-0170-8. Epub 2012 Aug 22.</citation>
    <PMID>22907572</PMID>
  </reference>
  <reference>
    <citation>Kern PM, Keilholz L, Forster C, Hallmann R, Herrmann M, Seegenschmiedt MH. Low-dose radiotherapy selectively reduces adhesion of peripheral blood mononuclear cells to endothelium in vitro. Radiother Oncol. 2000 Mar;54(3):273-82. doi: 10.1016/s0167-8140(00)00141-9.</citation>
    <PMID>10738086</PMID>
  </reference>
  <reference>
    <citation>Hildebrandt G, Seed MP, Freemantle CN, Alam CA, Colville-Nash PR, Trott KR. Mechanisms of the anti-inflammatory activity of low-dose radiation therapy. Int J Radiat Biol. 1998 Sep;74(3):367-78. doi: 10.1080/095530098141500.</citation>
    <PMID>9737539</PMID>
  </reference>
  <reference>
    <citation>Leer JW, van Houtte P, Davelaar J. Indications and treatment schedules for irradiation of benign diseases: a survey. Radiother Oncol. 1998 Sep;48(3):249-57. doi: 10.1016/s0167-8140(98)00051-6.</citation>
    <PMID>9925244</PMID>
  </reference>
  <results_reference>
    <citation>Ott OJ, Niewald M, Weitmann HD, Jacob I, Adamietz IA, Schaefer U, Keilholz L, Heyd R, Muecke R; German Cooperative Group on Radiotherapy for Benign Diseases (GCG-BD). DEGRO guidelines for the radiotherapy of non-malignant disorders. Part II: Painful degenerative skeletal disorders. Strahlenther Onkol. 2015 Jan;191(1):1-6. doi: 10.1007/s00066-014-0757-3. Epub 2014 Sep 20.</citation>
    <PMID>25238992</PMID>
  </results_reference>
  <results_reference>
    <citation>Seegenschmiedt MH, Katalinic A, Makoski H, Haase W, Gademann G, Hassenstein E. Radiation therapy for benign diseases: patterns of care study in Germany. Int J Radiat Oncol Biol Phys. 2000 Apr 1;47(1):195-202. doi: 10.1016/s0360-3016(99)00537-4.</citation>
    <PMID>10758324</PMID>
  </results_reference>
  <results_reference>
    <citation>Leer JW, van Houtte P, Seegenschmiedt H. Radiotherapy of non-malignant disorders: where do we stand? Radiother Oncol. 2007 May;83(2):175-7. doi: 10.1016/j.radonc.2007.04.008. Epub 2007 May 8.</citation>
    <PMID>17490769</PMID>
  </results_reference>
  <results_reference>
    <citation>Seegenschmiedt MH. New future for radiation therapy of non-malignant diseases? Radiother Oncol. 2005 Jan;74(1):1-2. doi: 10.1016/j.radonc.2005.01.001. No abstract available.</citation>
    <PMID>15683660</PMID>
  </results_reference>
  <results_reference>
    <citation>Micke O, Ugrak E, Bartmann S, Adamietz IA, Schaefer U, Bueker R, Kisters K, Heinrich Seegenschmiedt M, Fakhrian K, Muecke R. Radiotherapy for calcaneodynia, achillodynia, painful gonarthrosis, bursitis trochanterica, and painful shoulder syndrome - Early and late results of a prospective clinical quality assessment. Radiat Oncol. 2018 Apr 19;13(1):71. doi: 10.1186/s13014-018-1025-y.</citation>
    <PMID>29673383</PMID>
  </results_reference>
  <results_reference>
    <citation>Kriz J, Seegenschmiedt HM, Bartels A, Micke O, Muecke R, Schaefer U, Haverkamp U, Eich HT. Updated strategies in the treatment of benign diseases-a patterns of care study of the german cooperative group on benign diseases. Adv Radiat Oncol. 2018 Feb 26;3(3):240-244. doi: 10.1016/j.adro.2018.02.008. eCollection 2018 Jul-Sep.</citation>
    <PMID>30197936</PMID>
  </results_reference>
  <results_reference>
    <citation>Minten MJ, Mahler E, den Broeder AA, Leer JW, van den Ende CH. The efficacy and safety of low-dose radiotherapy on pain and functioning in patients with osteoarthritis: a systematic review. Rheumatol Int. 2016 Jan;36(1):133-42. doi: 10.1007/s00296-015-3337-7. Epub 2015 Aug 8.</citation>
    <PMID>26747050</PMID>
  </results_reference>
  <results_reference>
    <citation>Micke O, Seegenschmiedt MH, Adamietz IA, Kundt G, Fakhrian K, Schaefer U, Muecke R; German Cooperative Group on Radiotherapy for Nonmalignant Diseases (GCG-BD). Low-Dose Radiation Therapy for Benign Painful Skeletal Disorders: The Typical Treatment for the Elderly Patient? Int J Radiat Oncol Biol Phys. 2017 Jul 15;98(4):958-963. doi: 10.1016/j.ijrobp.2016.12.012. Epub 2016 Dec 18.</citation>
    <PMID>28258900</PMID>
  </results_reference>
  <results_reference>
    <citation>Koc BB, Schotanus MGM, Borghans R, Jong B, Maassen ME, Buijsen J, Jansen EJP. Short-term pain reduction after low-dose radiotherapy in patients with severe osteoarthritis of the hip or knee joint: a cohort study and literature review. Eur J Orthop Surg Traumatol. 2019 May;29(4):843-847. doi: 10.1007/s00590-019-02377-8. Epub 2019 Jan 16.</citation>
    <PMID>30649618</PMID>
  </results_reference>
  <results_reference>
    <citation>Mucke R, Seegenschmiedt MH, Heyd R, Schafer U, Prott FJ, Glatzel M, Micke O; German Cooperative Group on Radiotherapy for Benign Diseases (GCG-BD). [Radiotherapy in painful gonarthrosis. Results of a national patterns-of-care study]. Strahlenther Onkol. 2010 Jan;186(1):7-17. doi: 10.1007/s00066-009-1995-7. Epub 2009 Dec 28. German.</citation>
    <PMID>20082182</PMID>
  </results_reference>
  <results_reference>
    <citation>Seegenschmiedt MH, Micke O. [Radiotherapy of non-malignant diseases. Past, present and future]. Strahlenther Onkol. 2012 Nov;188 Suppl 3:272-90. doi: 10.1007/s00066-012-0195-z. No abstract available. German.</citation>
    <PMID>23053149</PMID>
  </results_reference>
  <results_reference>
    <citation>Reinartz G, Eich HT, Pohl F; German Cooperative Group on Radiotherapy for Benign Diseases (GCG-BD). DEGRO practical guidelines for the radiotherapy of non-malignant disorders - Part IV: Symptomatic functional disorders. Strahlenther Onkol. 2015 Apr;191(4):295-302. doi: 10.1007/s00066-014-0789-8. Epub 2014 Dec 9.</citation>
    <PMID>25487694</PMID>
  </results_reference>
  <results_reference>
    <citation>Keller S, Muller K, Kortmann RD, Wolf U, Hildebrandt G, Liebmann A, Micke O, Flemming G, Baaske D. Efficacy of low-dose radiotherapy in painful gonarthritis: experiences from a retrospective East German bicenter study. Radiat Oncol. 2013 Jan 31;8:29. doi: 10.1186/1748-717X-8-29.</citation>
    <PMID>23369282</PMID>
  </results_reference>
  <results_reference>
    <citation>Hautmann MG, Jung EM, Beyer LP, Suss C, Steger F, Weber M, Pohl F, Kolbl O, Putz FJ. Is low dose radiotherapy an effective treatment for Baker's cyst? Strahlenther Onkol. 2019 Jan;195(1):69-76. doi: 10.1007/s00066-018-1389-9. Epub 2018 Oct 30.</citation>
    <PMID>30377698</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 19, 2020</last_update_submitted>
  <last_update_submitted_qc>June 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Low Dose Radiotherapy</keyword>
  <keyword>Anti-inflammatory effects</keyword>
  <keyword>Pain release</keyword>
  <keyword>Quality of Life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis, Knee</mesh_term>
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Hip</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The overall results of any research conducted Will be available on study data publication&#xD;
Supportin information:&#xD;
Study protocol Informed Consent Form (ICF)</ipd_description>
  </patient_data>
  <!-- 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/NCT04424628
org study id: GEN-RAD-2019-01
nct id: NCT04424628
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a non-inferiority study in which the investigators compare two low-dose radiotherapy
      schemes, which are recommended from DEGRO Clinical Practice Guidelines (3 Gy vs 6 Gy) for the
      treatment of osteoarthritis and other osteodegenerative disorders.

      A first randomization will be carried out among the patients included in the study:

        -  Patients in arm A will be treated at 3 Gy (0.5 Gy/fraction, 3 fractions/week), and
           patients in arm B will be treated at 6 Gy (1 Gy/fraction, 3 fractions/week).

        -  Patients should not know the arm to which they have been randomized.

        -  Once the treatment is finished, patients will be assessed at 8 weeks. If pain does not
           improve, a re-irradiation will be performed. If the patients were treated with 3 Gy a
           new randomization will be performed (3 vs 6 Gy again). If the patiens were treated with
           6 Gy they will be re-irradiated with 6 Gy again.

      The investigators will analyze the results obtained depending on the dose received and
      depending on the location of the treatment.
Painfull skeletal disorders are susceptible to be treated with low-dose radiotherapy. DEGRO
      guidelines recommend a dose between 3 and 6 Gy at 0'5 Gy/fraction or 1 Gy/fraction
      respectively. The investigators want to verify that both treatments (3 and 6 Gy) are similar
      to improve the pain and function in patiens with gonarthrosis and coxarthrosis, and there are
      no differences between both treatments, therefore, 3 Gy is not less than 6 Gy.

      In this context, a prospective multicenter study is proposed. The study will include 338
      patients to assess the efficacy of low dose irradiation (3 vs 6 Gy) in gonarthrosis and
      coxarthrosis.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Arm 1: 3 Gy (repeated at 8 weeks if necessary. New ramdomization to 3 Gy or 6 Gy) Arm 2: 6 Gy (repeated at 8 weeks if necessry)
primary purpose: Supportive Care
masking: Single (Participant)
masking description: Patients label
measure: Pain control at 8-12 weeks and every 6 months
time frame: At 8-12 weeks, 6 months, 12 months, 18 months and 24 months
description: To evaluate the non inferiority efficacy of low dose radiotherapy 3 or 6 Gy to change in pain with VAS (Visual Analogue Scale). The patient scores his painfrom 0 (no hurt) to 10 (hurts worst). It is better a low score.
measure: Quality of Life at 8-12 weeks and every 6 months
time frame: At 8-12 weeks, 6 months, 12 months, 18 months and 24 months
description: To evaluate the non inferiority efficacy of low dose radiotherapy 3 or 6 Gy to change in pain with WOMAC scale (Western Ontario MacMaster Questionnaire). This questionnaire has 24 questions about pain, joint stiffness and joint function. It is better a low score.
measure: Skin toxicity at 8-12 weeks.
time frame: At 8-12 weeks.
description: Skin toxicity will be assessed and rated acording to the RTOG scale (0= no change over baseline; 1: Follicular, faint or dull erythema epilation, dry desquamation, decreased sweating; 2: Tender or bright erythema, patchy moist desquamation, moderate oedema; 3: Confluent, moist desquamation other tan skin folds, pitting oedema; 4: Ulceration haemorrhege, necrosis.
arm group label: Radiotherapy 3 Gy
arm group type: Active Comparator
description: Patiens will receive low dose gonarthrosis or coxarthrosis radiotherapy (0.5 Gy in 6 fractions alternating days).
Evaluation of pain releave and quality of live in 8-12 weeks If no effect the patient will be randomized to 3 or 6 Gy again
arm group label: Radiotherapy 6 Gy
arm group type: Active Comparator
description: Patiens will receive low dose gonarthrosis or coxarthrosis radiotherapy (1 Gy in 6 fractions alternating days).
Evaluation of pain releave and quality of live in 8-12 weeks If no effect the patient will be treated with 6 Gy again
intervention type: Radiation
intervention name: Low dose radiotherapy A
description: Low dose radiotherapy was 0.5 Gy in 6 fractions. Evaluation of pain and Quality of Life in 8-12 weeks. If no pain releave the patient is randomized to 3 or 6 Gy again
arm group label: Radiotherapy 3 Gy
intervention type: Radiation
intervention name: Low dose radiotherapy B
description: Low dose radiotherapy was 0.5 Gy in 6 fractions. Evaluation of pain and Quality of Life in 8-12 weeks. If no pain releave the patient is treated with 6 Gy again
arm group label: Radiotherapy 6 Gy
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Daniel Rivas Sanchez, MD
role: Principal Investigator
affiliation: Fundacion GenesisCare
last name: Daniel Rivas Sanchez, MD
phone: +34951569589
email: daniel.rivas@genesiscare.es
last name: Raul Hernaz, MD
phone: +34915644383
email: raul.hernanz@genesiscare.es
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Spain
citation: Micke O, Seegenschmiedt MH; German Working Group on Radiotherapy in Germany. Consensus guidelines for radiation therapy of benign diseases: a multicenter approach in Germany. Int J Radiat Oncol Biol Phys. 2002 Feb 1;52(2):496-513. doi: 10.1016/s0360-3016(01)01814-4.
PMID: 11872298
citation: Montero Luis A, Hernanz de Lucas R, Hervas Moron A, Fernandez Lizarbe E, Sancho Garcia S, Vallejo Ocana C, Polo Rubio A, Ramos Aguerri A. Radiation therapy for the treatment of benign vascular, skeletal and soft tissue diseases. Clin Transl Oncol. 2008 Jun;10(6):334-46. doi: 10.1007/s12094-008-0209-6.
PMID: 18558580
citation: Reichl B, Block A, Schafer U, Bert C, Muller R, Jung H, Rodel F; German Cooperative Group on Radiotherapy for Benign Diseases (GCG-BD). DEGRO practical guidelines for radiotherapy of non-malignant disorders: Part I: physical principles, radiobiological mechanisms, and radiogenic risk. Strahlenther Onkol. 2015 Sep;191(9):701-9. doi: 10.1007/s00066-015-0865-8. Epub 2015 Jun 28.
PMID: 26117368
citation: Smith-Bindman R, Lipson J, Marcus R, Kim KP, Mahesh M, Gould R, Berrington de Gonzalez A, Miglioretti DL. Radiation dose associated with common computed tomography examinations and the associated lifetime attributable risk of cancer. Arch Intern Med. 2009 Dec 14;169(22):2078-86. doi: 10.1001/archinternmed.2009.427.
PMID: 20008690
citation: Jansen JT, Broerse JJ, Zoetelief J, Klein C, Seegenschmiedt HM. Estimation of the carcinogenic risk of radiotherapy of benign diseases from shoulder to heel. Radiother Oncol. 2005 Sep;76(3):270-7. doi: 10.1016/j.radonc.2005.06.034.
PMID: 16157402
citation: Minten MJM, Leseman-Hoogenboom MM, Kloppenburg M, Kortekaas MC, Leer JW, Poortmans PMP, van den Hoogen FHJ, den Broeder AA, van den Ende CHM. Lack of beneficial effects of low-dose radiation therapy on hand osteoarthritis symptoms and inflammation: a randomised, blinded, sham-controlled trial. Osteoarthritis Cartilage. 2018 Oct;26(10):1283-1290. doi: 10.1016/j.joca.2018.06.010. Epub 2018 Jul 7.
PMID: 30231990
citation: Arenas M, Sabater S, Hernandez V, Rovirosa A, Lara PC, Biete A, Panes J. Anti-inflammatory effects of low-dose radiotherapy. Indications, dose, and radiobiological mechanisms involved. Strahlenther Onkol. 2012 Nov;188(11):975-81. doi: 10.1007/s00066-012-0170-8. Epub 2012 Aug 22.
PMID: 22907572
citation: Kern PM, Keilholz L, Forster C, Hallmann R, Herrmann M, Seegenschmiedt MH. Low-dose radiotherapy selectively reduces adhesion of peripheral blood mononuclear cells to endothelium in vitro. Radiother Oncol. 2000 Mar;54(3):273-82. doi: 10.1016/s0167-8140(00)00141-9.
PMID: 10738086
citation: Hildebrandt G, Seed MP, Freemantle CN, Alam CA, Colville-Nash PR, Trott KR. Mechanisms of the anti-inflammatory activity of low-dose radiation therapy. Int J Radiat Biol. 1998 Sep;74(3):367-78. doi: 10.1080/095530098141500.
PMID: 9737539
citation: Leer JW, van Houtte P, Davelaar J. Indications and treatment schedules for irradiation of benign diseases: a survey. Radiother Oncol. 1998 Sep;48(3):249-57. doi: 10.1016/s0167-8140(98)00051-6.
PMID: 9925244
citation: Ott OJ, Niewald M, Weitmann HD, Jacob I, Adamietz IA, Schaefer U, Keilholz L, Heyd R, Muecke R; German Cooperative Group on Radiotherapy for Benign Diseases (GCG-BD). DEGRO guidelines for the radiotherapy of non-malignant disorders. Part II: Painful degenerative skeletal disorders. Strahlenther Onkol. 2015 Jan;191(1):1-6. doi: 10.1007/s00066-014-0757-3. Epub 2014 Sep 20.
PMID: 25238992
citation: Seegenschmiedt MH, Katalinic A, Makoski H, Haase W, Gademann G, Hassenstein E. Radiation therapy for benign diseases: patterns of care study in Germany. Int J Radiat Oncol Biol Phys. 2000 Apr 1;47(1):195-202. doi: 10.1016/s0360-3016(99)00537-4.
PMID: 10758324
citation: Leer JW, van Houtte P, Seegenschmiedt H. Radiotherapy of non-malignant disorders: where do we stand? Radiother Oncol. 2007 May;83(2):175-7. doi: 10.1016/j.radonc.2007.04.008. Epub 2007 May 8.
PMID: 17490769
citation: Seegenschmiedt MH. New future for radiation therapy of non-malignant diseases? Radiother Oncol. 2005 Jan;74(1):1-2. doi: 10.1016/j.radonc.2005.01.001. No abstract available.
PMID: 15683660
citation: Micke O, Ugrak E, Bartmann S, Adamietz IA, Schaefer U, Bueker R, Kisters K, Heinrich Seegenschmiedt M, Fakhrian K, Muecke R. Radiotherapy for calcaneodynia, achillodynia, painful gonarthrosis, bursitis trochanterica, and painful shoulder syndrome - Early and late results of a prospective clinical quality assessment. Radiat Oncol. 2018 Apr 19;13(1):71. doi: 10.1186/s13014-018-1025-y.
PMID: 29673383
citation: Kriz J, Seegenschmiedt HM, Bartels A, Micke O, Muecke R, Schaefer U, Haverkamp U, Eich HT. Updated strategies in the treatment of benign diseases-a patterns of care study of the german cooperative group on benign diseases. Adv Radiat Oncol. 2018 Feb 26;3(3):240-244. doi: 10.1016/j.adro.2018.02.008. eCollection 2018 Jul-Sep.
PMID: 30197936
citation: Minten MJ, Mahler E, den Broeder AA, Leer JW, van den Ende CH. The efficacy and safety of low-dose radiotherapy on pain and functioning in patients with osteoarthritis: a systematic review. Rheumatol Int. 2016 Jan;36(1):133-42. doi: 10.1007/s00296-015-3337-7. Epub 2015 Aug 8.
PMID: 26747050
citation: Micke O, Seegenschmiedt MH, Adamietz IA, Kundt G, Fakhrian K, Schaefer U, Muecke R; German Cooperative Group on Radiotherapy for Nonmalignant Diseases (GCG-BD). Low-Dose Radiation Therapy for Benign Painful Skeletal Disorders: The Typical Treatment for the Elderly Patient? Int J Radiat Oncol Biol Phys. 2017 Jul 15;98(4):958-963. doi: 10.1016/j.ijrobp.2016.12.012. Epub 2016 Dec 18.
PMID: 28258900
citation: Koc BB, Schotanus MGM, Borghans R, Jong B, Maassen ME, Buijsen J, Jansen EJP. Short-term pain reduction after low-dose radiotherapy in patients with severe osteoarthritis of the hip or knee joint: a cohort study and literature review. Eur J Orthop Surg Traumatol. 2019 May;29(4):843-847. doi: 10.1007/s00590-019-02377-8. Epub 2019 Jan 16.
PMID: 30649618
citation: Mucke R, Seegenschmiedt MH, Heyd R, Schafer U, Prott FJ, Glatzel M, Micke O; German Cooperative Group on Radiotherapy for Benign Diseases (GCG-BD). [Radiotherapy in painful gonarthrosis. Results of a national patterns-of-care study]. Strahlenther Onkol. 2010 Jan;186(1):7-17. doi: 10.1007/s00066-009-1995-7. Epub 2009 Dec 28. German.
PMID: 20082182
citation: Seegenschmiedt MH, Micke O. [Radiotherapy of non-malignant diseases. Past, present and future]. Strahlenther Onkol. 2012 Nov;188 Suppl 3:272-90. doi: 10.1007/s00066-012-0195-z. No abstract available. German.
PMID: 23053149
citation: Reinartz G, Eich HT, Pohl F; German Cooperative Group on Radiotherapy for Benign Diseases (GCG-BD). DEGRO practical guidelines for the radiotherapy of non-malignant disorders - Part IV: Symptomatic functional disorders. Strahlenther Onkol. 2015 Apr;191(4):295-302. doi: 10.1007/s00066-014-0789-8. Epub 2014 Dec 9.
PMID: 25487694
citation: Keller S, Muller K, Kortmann RD, Wolf U, Hildebrandt G, Liebmann A, Micke O, Flemming G, Baaske D. Efficacy of low-dose radiotherapy in painful gonarthritis: experiences from a retrospective East German bicenter study. Radiat Oncol. 2013 Jan 31;8:29. doi: 10.1186/1748-717X-8-29.
PMID: 23369282
citation: Hautmann MG, Jung EM, Beyer LP, Suss C, Steger F, Weber M, Pohl F, Kolbl O, Putz FJ. Is low dose radiotherapy an effective treatment for Baker's cyst? Strahlenther Onkol. 2019 Jan;195(1):69-76. doi: 10.1007/s00066-018-1389-9. Epub 2018 Oct 30.
PMID: 30377698
responsible party type: Sponsor
mesh term: Osteoarthritis, Knee
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Hip
sharing ipd: No
ipd description: The overall results of any research conducted Will be available on study data publication
Supportin information:
Study protocol Informed Consent Form (ICF)