xml: <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/NCT05994300</url>
    </required_header>
    <id_info>
      <org_study_id>K4477</org_study_id>
      <nct_id>NCT05994300</nct_id>
    </id_info>
    <brief_title>Moderately Hypofractionated Adaptive Radiotherapy for Cervical Cancer</brief_title>
    <official_title>Clinical Research of Moderately Hypofractionated Radiotherapy for Cervical Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking Union Medical College Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking Union Medical College Hospital</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>
        External radiation given in 25 fractions or so together with weekly chemotherapy and followed&#xD;
        by 5 or 6 fractions of brachytherapy is the standard of care for patients with locally&#xD;
        advanced cervical cancer. We hope to develop external moderately hypofractionated&#xD;
        radiotherapy of cervical cancer based on adaptive radiotherapy.The objective of this study is&#xD;
        to evaluate the efficacy and treatment-related toxicity of moderately hypofractionated&#xD;
        adaptive radiotherapy in the treatment of cervical cancer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is an investigator-initiated efficacious, single-center, open-label clinical trial&#xD;
        study. This study hypothesizes that the use of external moderately hypofractionated&#xD;
        radiotherapy of cervical cancer based on adaptive radiotherapy. A dose of 43.35Gy in 17&#xD;
        fractions is delivered to clinical target volume (CTV). Patients receive cisplatin based&#xD;
        concurrent chemotherapy. The primary endpoint is acute toxicity.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 15, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Acute toxicity</measure>
      <time_frame>3 months</time_frame>
      <description>This outcome is assessed by physicians during each follow-up appointment, and scored according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 . Clinically relevant toxicities of gastrointestinal, genitourinary, vaginal and non-specific general symptoms (i.e. fatigue, malaise and pain) will be collected. Hematological disorders will also be collected through weekly blood work checks. Acute toxicities will be collected at baseline, and then weekly during radiotherapy/chemoradiotherapy and at 3 months after completion of radiation.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Late toxicity</measure>
      <time_frame>3 years</time_frame>
      <description>Late toxicities will be collected from 3 months after completion of radiation onwards until the end of follow-up.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Response evaluation evaluated with RECIST 1.1</measure>
      <time_frame>One month after treatment</time_frame>
      <description>Evaluated with RECIST 1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease-free survival</measure>
      <time_frame>3 years</time_frame>
      <description>Disease-free survival was defined as the period from the diagnosis of cervical cancer to events that included death or disease progression at local, regional, or distant sites or until the date of the last follow-up.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival</measure>
      <time_frame>3 years</time_frame>
      <description>Overall survival was defined as the period from the diagnosis of cervical cancer to the date of death or last follow-up.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life (QoL)</measure>
      <time_frame>3 years</time_frame>
      <description>QoL will be measured by the Expanded Prostate Cancer Index Composite (EPIC) questionnaire. The EPIC questionnaire contains 32 questions measuring patient function. Each question has a response option ranging from 0 or 1 (best) to 3, 4, or 5 (worst). The responses then correlate to a scoring scale of 0 to 100, where 0 is the best and 100 is the worst. The scores can then be added to come up with an overall quality of life score.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life (QoL)</measure>
      <time_frame>3 years</time_frame>
      <description>QoL will evaluated by the EORTC QLQ-C-30 questionnaire.QLQ-C30 questionnaire is used for all cancers and has several symptom scales, five functional scales (physical, emotional, social, role, cognitive) and a global health status scale. Response options are a four-point Likert scale from &quot;not at all&quot; to &quot;very much&quot; or a seven-point Likert scale from &quot;very poor&quot; to &quot;excellent.&quot;</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Cervical Neoplasm</condition>
    <condition>Adaptive Radiotherapy</condition>
    <condition>Radiotherapy; Adverse Effect</condition>
    <arm_group>
      <arm_group_label>Moderately Hypofractionated Adaptive Radiotherapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Moderately hypofractionated adaptive radiotherapy (ART)+ High-dose rate (HDR) Brachytherapy</intervention_name>
      <description>Experimental: 43.35Gy/17F external beam radiotherapy (EBRT) with adaptive radiotherapy (ART) + HDR-Brachytherapy&#xD;
  Drug: Concurrent Chemotherapy&#xD;
  Weekly cisplatin 40 mg/m2</description>
      <arm_group_label>Moderately Hypofractionated Adaptive Radiotherapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Age 18 years to 70 years&#xD;
  &#xD;
          FIGO Stage IB1, IB2, IB3, IIA or IIB cervical cancers&#xD;
  &#xD;
          FIGO stage IIIC1 cervical cancers are candidates but must meet all the following&#xD;
          criteria:largest node is less than 1.5 cm,less than 3 pathological nodes,No nodes located&#xD;
          in the common iliac chain&#xD;
  &#xD;
          Histology: squamous&#xD;
  &#xD;
          Candidate for definitive chemoradiotherapy to be delivered with weekly cisplatin&#xD;
  &#xD;
          Brachytherapy candidate&#xD;
  &#xD;
          Functional State Eastern Cooperative Oncology Group (ECOG)0-2&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patients who had chemotherapeutic, surgical and/or radiotherapy treatment&#xD;
  &#xD;
          FIGO stage IIIA, IIIB, IIIC2, IVA or IVB&#xD;
  &#xD;
          FIGO stage IIIC1 with node greater than 1.5 cm, common iliac node or greater than 2&#xD;
          pathological nodes&#xD;
  &#xD;
          Previous pelvic or abdominal radiotherapy&#xD;
  &#xD;
          Patient unable to undergo MR scan&#xD;
  &#xD;
          ECOG performance status greater than 2&#xD;
  &#xD;
          Not a cisplatin candidate&#xD;
  &#xD;
          Other factors that contraindicate experimental therapy&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Fuquan Zhang, MD</last_name>
      <role>Study Chair</role>
      <affiliation>Peking Union Medical College Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Fuquan Zhang, MD</last_name>
      <phone>86-10-6915-5485</phone>
      <email>Zhangfq@pumch.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Zheng Zeng, MD</last_name>
      <phone>86-10-6915-5487</phone>
      <email>zengzheng1206@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Peking Union Medical College Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100010</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Fuquan Zhang, prof</last_name>
        <phone>86-10-69155485</phone>
        <email>Zhangfq@pumch.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 5, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>moderately hypofractionated radiotherapy</keyword>
    <keyword>adaptive radiotherapy</keyword>
    <keyword>cervical cancer.</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Uterine Cervical Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>To protect the privacy of the patients</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05994300
  org study id: K4477
  nct id: NCT05994300
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  External radiation given in 25 fractions or so together with weekly chemotherapy and followed
        by 5 or 6 fractions of brachytherapy is the standard of care for patients with locally
        advanced cervical cancer. We hope to develop external moderately hypofractionated
        radiotherapy of cervical cancer based on adaptive radiotherapy.The objective of this study is
        to evaluate the efficacy and treatment-related toxicity of moderately hypofractionated
        adaptive radiotherapy in the treatment of cervical cancer.
  This is an investigator-initiated efficacious, single-center, open-label clinical trial
        study. This study hypothesizes that the use of external moderately hypofractionated
        radiotherapy of cervical cancer based on adaptive radiotherapy. A dose of 43.35Gy in 17
        fractions is delivered to clinical target volume (CTV). Patients receive cisplatin based
        concurrent chemotherapy. The primary endpoint is acute toxicity.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Acute toxicity
  time frame: 3 months
  description: This outcome is assessed by physicians during each follow-up appointment, and scored according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 . Clinically relevant toxicities of gastrointestinal, genitourinary, vaginal and non-specific general symptoms (i.e. fatigue, malaise and pain) will be collected. Hematological disorders will also be collected through weekly blood work checks. Acute toxicities will be collected at baseline, and then weekly during radiotherapy/chemoradiotherapy and at 3 months after completion of radiation.
  measure: Late toxicity
  time frame: 3 years
  description: Late toxicities will be collected from 3 months after completion of radiation onwards until the end of follow-up.
  measure: Response evaluation evaluated with RECIST 1.1
  time frame: One month after treatment
  description: Evaluated with RECIST 1.1
  measure: Disease-free survival
  time frame: 3 years
  description: Disease-free survival was defined as the period from the diagnosis of cervical cancer to events that included death or disease progression at local, regional, or distant sites or until the date of the last follow-up.
  measure: Overall survival
  time frame: 3 years
  description: Overall survival was defined as the period from the diagnosis of cervical cancer to the date of death or last follow-up.
  measure: Quality of life (QoL)
  time frame: 3 years
  description: QoL will be measured by the Expanded Prostate Cancer Index Composite (EPIC) questionnaire. The EPIC questionnaire contains 32 questions measuring patient function. Each question has a response option ranging from 0 or 1 (best) to 3, 4, or 5 (worst). The responses then correlate to a scoring scale of 0 to 100, where 0 is the best and 100 is the worst. The scores can then be added to come up with an overall quality of life score.
  measure: Quality of life (QoL)
  time frame: 3 years
  description: QoL will evaluated by the EORTC QLQ-C-30 questionnaire.QLQ-C30 questionnaire is used for all cancers and has several symptom scales, five functional scales (physical, emotional, social, role, cognitive) and a global health status scale. Response options are a four-point Likert scale from "not at all" to "very much" or a seven-point Likert scale from "very poor" to "excellent."
  arm group label: Moderately Hypofractionated Adaptive Radiotherapy
  arm group type: Experimental
  intervention type: Radiation
  intervention name: Moderately hypofractionated adaptive radiotherapy (ART)+ High-dose rate (HDR) Brachytherapy
  description: Experimental: 43.35Gy/17F external beam radiotherapy (EBRT) with adaptive radiotherapy (ART) + HDR-Brachytherapy
  Drug: Concurrent Chemotherapy
  Weekly cisplatin 40 mg/m2
  arm group label: Moderately Hypofractionated Adaptive Radiotherapy
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Fuquan Zhang, MD
  role: Study Chair
  affiliation: Peking Union Medical College Hospital
  last name: Fuquan Zhang, MD
  phone: 86-10-6915-5485
  email: Zhangfq@pumch.cn
  last name: Zheng Zeng, MD
  phone: 86-10-6915-5487
  email: zengzheng1206@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Uterine Cervical Neoplasms
  sharing ipd: No
  ipd description: To protect the privacy of the patients