<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/NCT04434677</url>
  </required_header>
  <id_info>
    <org_study_id>0201263</org_study_id>
    <nct_id>NCT04434677</nct_id>
  </id_info>
  <brief_title>Hypofractionation And Ultra-Hypofractionation In Adjuvant Radiotherapy For Breast Cancer</brief_title>
  <official_title>Comparative Study Between Hypofractionation And Ultra-Hypofractionation In Adjuvant Radiotherapy For Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alexandria University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alexandria University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Prospective randomized study comparing 5 fractions in alternative days to standard 15&#xD;
      fractions regarding effectiveness and feasibility during adjuvant treatment in breast caner&#xD;
      patients aged above 50 years&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In Alexandria, the number of working linear machines are limited with overcrowded waiting&#xD;
      list which lead to prolongation of overall treatment time and delay in starting radiotherapy.&#xD;
      Providing the available data, Principle investigator is conducting this study in parallel&#xD;
      with fast forward protocol to provide an alternative cost effective approach to patients.&#xD;
&#xD;
      The rationale behind hypofractionation depends mainly on the alpha beta ratio (α/β) and the&#xD;
      overall treatment time. In Breast cancer the ratio is around 4 which is slightly lower than&#xD;
      other tumors such as head and neck. The lower the ratio the higher the dose per fraction is&#xD;
      needed to compensate slower proliferating tumors. Also, the overall treatment time could&#xD;
      affect the local recurrence of breast cancer which is increased with long duration of&#xD;
      treatment.&#xD;
&#xD;
      This study will include at least 100 patients with non metastatic histologically proved&#xD;
      breast cancer who are indicated for adjuvant radiotherapy.&#xD;
&#xD;
      The patients will be randomized into two arms:&#xD;
&#xD;
        -  Control arm: will include 50 patients who will receive standard 40.05 Gray (2.67 Gy/fx)&#xD;
           over 15 fractions with or without boost over 3 weeks biologically effective dose (BED)&#xD;
           for early and late effect equal 50.74.Gy10 and 75.69 Gy3 respectively.&#xD;
&#xD;
        -  Experimental arm: will include 50 patients who will receive 26 Gray (5.2 Gy/fx) over 5&#xD;
           fractions over 1.5 weeks with BED for early and late effect equal 39.52 Gy10 and 71.07&#xD;
           Gy3 respectively&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 28, 2019</start_date>
  <completion_date type="Anticipated">June 28, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 28, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of Acute grade 2 or higher toxicity (NCI-CTCAE)</measure>
    <time_frame>Start of treatment till 3 months from end of treatment</time_frame>
    <description>Each patient will be assessed weekly during radiotherapy and monthly for three months post radiotherapy to assess acute toxicity and will be documented according to Common Terminology Criteria for adverse events (CTCAE)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of chronic Toxicity grade 2 or higher (NCI-CTCAE)</measure>
    <time_frame>Before start treatment and from 6 months after finishing treatment every 6 months up to average 2 years</time_frame>
    <description>Each patient will be assessed before treatment and at 6 , 12 , 24 months for chronic toxicity Criteria for adverse events (CTCAE)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of Ipsilateral local tumor recurrence</measure>
    <time_frame>1 to 2 years</time_frame>
    <description>Local recurrence proved by image and biopsy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Compliance to treatment (number of interrupted days of radiation)</measure>
    <time_frame>Start treatment till end of treatment (2 weeks in arm one and 3 weeks in arm2)</time_frame>
    <description>Treatment interruptions of planned cycles</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>From date of diagnosis up to average 2 years</time_frame>
    <description>the percentage of people in a study or treatment group who are alive two years after the start of treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Hypofractionation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control arm:patients who will receive standard 40.05 Gray (2.67 Gy/ fx) over 15 fractions with or without boost over 3 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ultrahypofractionation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental arm: Patients who will receive 26 Gray (5.2 Gy/fx) over 5 fractions over 1.5 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Hypofractionation</intervention_name>
    <description>3D conformal Radiotherapy whole breast irradiation +- Supraclavicular fossa using Linear Machine (6-15 MV energy) 40.05 Gray (2.67 Gy/ fx) over 15 fractions with or without boost over 3 weeks</description>
    <arm_group_label>Hypofractionation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>ultraHypofractionation</intervention_name>
    <description>3D conformal Radiotherapy whole breast irradiation +- Supraclavicular fossa using Linear Machine (6-15 MV energy) 26 Gray (5.2 Gy/fx) over 5 fractions over 1.5 weeks</description>
    <arm_group_label>Ultrahypofractionation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥50 years old.&#xD;
&#xD;
          -  Informed consent.&#xD;
&#xD;
          -  Either breast conservative surgery or mastectomy.&#xD;
&#xD;
          -  Invasive breast cancer with p T1-3, p N0-2.&#xD;
&#xD;
          -  Non metastatic breast cancer proven by clinical examinations and imaging (X-ray chest&#xD;
             and ultrasound or CT scan chest and abdomen).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of distant metastases.&#xD;
&#xD;
          -  Prior irradiation.&#xD;
&#xD;
          -  Inflammatory breast cancer.&#xD;
&#xD;
          -  Tumor with T4 (skin nodules or fixed to chest wall or ulceration).&#xD;
&#xD;
          -  Tumor with positive margins.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ashraf M El-Enbaby, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alexandria University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amr Munir</last_name>
    <phone>+201227241185</phone>
    <email>dr.amr.munir@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>ACOD</name>
      <address>
        <city>Alexandria</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Abdelaziz Belal, PHD</last_name>
      <phone>+201223318257</phone>
      <email>abdelazizbelal@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>March 30, 2021</last_update_submitted>
  <last_update_submitted_qc>March 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>radiotherapy</keyword>
  <keyword>hypofractionation</keyword>
  <keyword>ultrahypofractionation</keyword>
  <keyword>5 fractions</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast 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/NCT04434677
org study id: 0201263
nct id: NCT04434677
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Prospective randomized study comparing 5 fractions in alternative days to standard 15
      fractions regarding effectiveness and feasibility during adjuvant treatment in breast caner
      patients aged above 50 years
In Alexandria, the number of working linear machines are limited with overcrowded waiting
      list which lead to prolongation of overall treatment time and delay in starting radiotherapy.
      Providing the available data, Principle investigator is conducting this study in parallel
      with fast forward protocol to provide an alternative cost effective approach to patients.

      The rationale behind hypofractionation depends mainly on the alpha beta ratio (α/β) and the
      overall treatment time. In Breast cancer the ratio is around 4 which is slightly lower than
      other tumors such as head and neck. The lower the ratio the higher the dose per fraction is
      needed to compensate slower proliferating tumors. Also, the overall treatment time could
      affect the local recurrence of breast cancer which is increased with long duration of
      treatment.

      This study will include at least 100 patients with non metastatic histologically proved
      breast cancer who are indicated for adjuvant radiotherapy.

      The patients will be randomized into two arms:

        -  Control arm: will include 50 patients who will receive standard 40.05 Gray (2.67 Gy/fx)
           over 15 fractions with or without boost over 3 weeks biologically effective dose (BED)
           for early and late effect equal 50.74.Gy10 and 75.69 Gy3 respectively.

        -  Experimental arm: will include 50 patients who will receive 26 Gray (5.2 Gy/fx) over 5
           fractions over 1.5 weeks with BED for early and late effect equal 39.52 Gy10 and 71.07
           Gy3 respectively
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of Acute grade 2 or higher toxicity (NCI-CTCAE)
time frame: Start of treatment till 3 months from end of treatment
description: Each patient will be assessed weekly during radiotherapy and monthly for three months post radiotherapy to assess acute toxicity and will be documented according to Common Terminology Criteria for adverse events (CTCAE)
measure: Rate of chronic Toxicity grade 2 or higher (NCI-CTCAE)
time frame: Before start treatment and from 6 months after finishing treatment every 6 months up to average 2 years
description: Each patient will be assessed before treatment and at 6 , 12 , 24 months for chronic toxicity Criteria for adverse events (CTCAE)
measure: Rate of Ipsilateral local tumor recurrence
time frame: 1 to 2 years
description: Local recurrence proved by image and biopsy
measure: Compliance to treatment (number of interrupted days of radiation)
time frame: Start treatment till end of treatment (2 weeks in arm one and 3 weeks in arm2)
description: Treatment interruptions of planned cycles
measure: Overall survival
time frame: From date of diagnosis up to average 2 years
description: the percentage of people in a study or treatment group who are alive two years after the start of treatment.
arm group label: Hypofractionation
arm group type: Active Comparator
description: Control arm:patients who will receive standard 40.05 Gray (2.67 Gy/ fx) over 15 fractions with or without boost over 3 weeks
arm group label: Ultrahypofractionation
arm group type: Experimental
description: Experimental arm: Patients who will receive 26 Gray (5.2 Gy/fx) over 5 fractions over 1.5 weeks
intervention type: Radiation
intervention name: Hypofractionation
description: 3D conformal Radiotherapy whole breast irradiation +- Supraclavicular fossa using Linear Machine (6-15 MV energy) 40.05 Gray (2.67 Gy/ fx) over 15 fractions with or without boost over 3 weeks
arm group label: Hypofractionation
intervention type: Radiation
intervention name: ultraHypofractionation
description: 3D conformal Radiotherapy whole breast irradiation +- Supraclavicular fossa using Linear Machine (6-15 MV energy) 26 Gray (5.2 Gy/fx) over 5 fractions over 1.5 weeks
arm group label: Ultrahypofractionation
criteria: 
gender: Female
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Ashraf M El-Enbaby, Prof
role: Principal Investigator
affiliation: Alexandria University
last name: Amr Munir
phone: +201227241185
email: dr.amr.munir@gmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Sponsor
mesh term: Breast Neoplasms