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/NCT05979961</url>
    </required_header>
    <id_info>
      <org_study_id>2022-FXY-298</org_study_id>
      <nct_id>NCT05979961</nct_id>
    </id_info>
    <brief_title>Phase III Trial of Concurrent Chemotherapy Alone in Patients With Low-risk Nasopharyngeal Carcinoma</brief_title>
    <official_title>Concurrent Chemoradiotherapy Alone Versus Induction Chemotherapy Plus Concurrent Chemoradiotherapy in Low-risk Locoregionally Advanced Nasopharyngeal Carcinoma: a Phase 3, Multicentre, Randomised Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sun Yat-sen University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sun Yat-sen 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>
        The purpose of this study is to compare concurrent chemoradiotherapy (CCRT) alone with&#xD;
        induction chemotherapy (gemcitabine+cisplatin) plus CCRT in patients with low-risk&#xD;
        locoregionally advanced nasopharyngeal carcinoma(NPC).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients with low risk NPC( Stage III-IVa, except T4N2/AnyTN3, AJCC 8th and EBV DNA &lt;4000&#xD;
        copies/ml) are randomly assigned to receive CCRT alone or induction chemotherapy plus CCRT.&#xD;
        Patients in both groups receive cisplatin 100 mg/m² every 3 weeks for 3 cycles, concurrently&#xD;
        with intensity-modulated radiotherapy (IMRT). IMRT is given as 2.12 Gy per fraction with five&#xD;
        daily fractions per week to a total dose of 70 Gy. The induction chemotherapy plus CCRT group&#xD;
        receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for three&#xD;
        cycles before CCRT. Our primary endpoint is progress-free survival. Secondary end points&#xD;
        include overall survival (OS), Locoregional progression, Distant progression and toxic&#xD;
        effects. All efficacy analyses are conducted in the intention-to-treat population, and the&#xD;
        safety population include only patients who receive their randomly assigned treatment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">July 2027</completion_date>
    <primary_completion_date type="Anticipated">July 2025</primary_completion_date>
    <phase>Phase 3</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>Progress-free survival(PFS)</measure>
      <time_frame>2 years</time_frame>
      <description>defined as the time from random assignment to documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Overall survival(OS)</measure>
      <time_frame>2 years</time_frame>
      <description>defined as the time from random assignment to death from any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Locoregional progression</measure>
      <time_frame>2 years</time_frame>
      <description>defined as the time from random assignment to the occurrence of a locoregional progression. Cumulative incidence of locoregional progression will be calculated within a competing risk framework (Fine and Gray 1999).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Distant progression</measure>
      <time_frame>2 years</time_frame>
      <description>defined as the time from random assignment to the occurrence of a distant progression. Cumulative incidence of distant progression will be calculated within a competing risk framework (Fine and Gray 1999).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall response rate</measure>
      <time_frame>16 weeks after completion of concurrent chemoradiotherapy</time_frame>
      <description>Tumour response was classified according to RECIST, version 1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of acute and late toxicity</measure>
      <time_frame>2 years</time_frame>
      <description>Incidence of acute toxicity is calculated for each adverse event respectively and severity is evaluated on basis of Common Terminology Criteria for Adverse Events (CTCAE) 5.0 criteria. Late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">424</enrollment>
    <condition>Nasopharyngeal Carcinoma</condition>
    <arm_group>
      <arm_group_label>IMRT and concurrent cisplatin</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 3 cycles.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Induction chemotherapy+IMRT and concurrent cisplatin</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 3 cycles.</description>
    </arm_group>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>IMRT and concurrent cisplatin</intervention_name>
      <description>Patients receive concurrent cisplatin 100mg/m2 every 21days for three cycles during Intensity modulated radiotherapy (IMRT)</description>
      <arm_group_label>IMRT and concurrent cisplatin</arm_group_label>
      <arm_group_label>Induction chemotherapy+IMRT and concurrent cisplatin</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>gemcitabine and cisplatin (Induction chemotherapy)</intervention_name>
      <description>Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy</description>
      <arm_group_label>Induction chemotherapy+IMRT and concurrent cisplatin</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 18-70 years old.&#xD;
  &#xD;
            2. Patients with newly histologically confirmed non-keratinizing (according to WHO&#xD;
               histologically type).&#xD;
  &#xD;
            3. Tumor staged as III-IVa except T4N2/AnyTN3 (according to the 8th AJCC edition) and&#xD;
               pretreatment plasm EB Virus DNA&lt;4000copies/ml.&#xD;
  &#xD;
            4. ECOG Performance status less or equal to 1.&#xD;
  &#xD;
            5. Male and no pregnant female.&#xD;
  &#xD;
            6. Adequate marrow: leucocyte count ≥ 4000/μL, hemoglobin ≥ 90g/L and platelet count ≥&#xD;
               100000/μL.&#xD;
  &#xD;
            7. Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase&#xD;
               (AST) &lt; 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) &lt;&#xD;
               2.5×ULN, and bilirubin &lt; ULN.&#xD;
  &#xD;
            8. Adequate renal function: creatinine clearance ≥ 60 ml/min.&#xD;
  &#xD;
            9. Patients must be informed of the investigational nature of this study and give written&#xD;
               informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients have evidence of relapse or distant metastasis.&#xD;
  &#xD;
            2. WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.&#xD;
  &#xD;
            3. Treatment with palliative intent.&#xD;
  &#xD;
            4. History of previous RT (except for non-melanomatous skin cancers outside intended RT&#xD;
               treatment volume).&#xD;
  &#xD;
            5. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.&#xD;
  &#xD;
            6. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and&#xD;
               emphasize effective contraception during the treatment period).&#xD;
  &#xD;
            7. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in&#xD;
               situ cervical cancer.&#xD;
  &#xD;
            8. Any severe intercurrent disease, which may bring unacceptable risk or affect the&#xD;
               compliance of the trial, for example, unstable cardiac disease requiring treatment,&#xD;
               renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose &gt;&#xD;
               1.5×ULN), and emotional disturbance.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Hai-Qiang Mai</last_name>
      <phone>862087343643</phone>
      <email>maihq@sysucc.org.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Guangzhou Medical University</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510000</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Dong-Ping Chen, MD</last_name>
        <phone>13302215492</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Sun Yat-sen University</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510062</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Yong Chen, MD</last_name>
        <phone>13826266676</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Zhongshan City People's Hospital</name>
        <address>
          <city>Zhongshan</city>
          <state>Guangdong</state>
          <zip>528499</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Feng Lei, MD</last_name>
        <phone>13528227676</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Guangxi Medical University</name>
        <address>
          <city>Nanning</city>
          <state>Guangxi</state>
          <zip>530021</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Ren-Sheng Wang, MD</last_name>
        <phone>13807806008</phone>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>July 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 30, 2023</last_update_submitted>
    <last_update_submitted_qc>July 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
      <investigator_full_name>Hai-Qiang Mai,MD,PhD</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Nasopharyngeal Carcinoma</keyword>
    <keyword>Induction Chemotherapy</keyword>
    <keyword>Concurrent Chemotherapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma</mesh_term>
      <mesh_term>Nasopharyngeal Carcinoma</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cisplatin</mesh_term>
      <mesh_term>Gemcitabine</mesh_term>
    </intervention_browse>
    <!-- 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/NCT05979961
  org study id: 2022-FXY-298
  nct id: NCT05979961
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to compare concurrent chemoradiotherapy (CCRT) alone with
        induction chemotherapy (gemcitabine+cisplatin) plus CCRT in patients with low-risk
        locoregionally advanced nasopharyngeal carcinoma(NPC).
  Patients with low risk NPC( Stage III-IVa, except T4N2/AnyTN3, AJCC 8th and EBV DNA <4000
        copies/ml) are randomly assigned to receive CCRT alone or induction chemotherapy plus CCRT.
        Patients in both groups receive cisplatin 100 mg/m² every 3 weeks for 3 cycles, concurrently
        with intensity-modulated radiotherapy (IMRT). IMRT is given as 2.12 Gy per fraction with five
        daily fractions per week to a total dose of 70 Gy. The induction chemotherapy plus CCRT group
        receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for three
        cycles before CCRT. Our primary endpoint is progress-free survival. Secondary end points
        include overall survival (OS), Locoregional progression, Distant progression and toxic
        effects. All efficacy analyses are conducted in the intention-to-treat population, and the
        safety population include only patients who receive their randomly assigned treatment.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Progress-free survival(PFS)
  time frame: 2 years
  description: defined as the time from random assignment to documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first.
  measure: Overall survival(OS)
  time frame: 2 years
  description: defined as the time from random assignment to death from any cause.
  measure: Locoregional progression
  time frame: 2 years
  description: defined as the time from random assignment to the occurrence of a locoregional progression. Cumulative incidence of locoregional progression will be calculated within a competing risk framework (Fine and Gray 1999).
  measure: Distant progression
  time frame: 2 years
  description: defined as the time from random assignment to the occurrence of a distant progression. Cumulative incidence of distant progression will be calculated within a competing risk framework (Fine and Gray 1999).
  measure: Overall response rate
  time frame: 16 weeks after completion of concurrent chemoradiotherapy
  description: Tumour response was classified according to RECIST, version 1.1
  measure: Incidence of acute and late toxicity
  time frame: 2 years
  description: Incidence of acute toxicity is calculated for each adverse event respectively and severity is evaluated on basis of Common Terminology Criteria for Adverse Events (CTCAE) 5.0 criteria. Late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme.
  arm group label: IMRT and concurrent cisplatin
  arm group type: Experimental
  description: Patients receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 3 cycles.
  arm group label: Induction chemotherapy+IMRT and concurrent cisplatin
  arm group type: Active Comparator
  description: Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 3 cycles.
  intervention type: Radiation
  intervention name: IMRT and concurrent cisplatin
  description: Patients receive concurrent cisplatin 100mg/m2 every 21days for three cycles during Intensity modulated radiotherapy (IMRT)
  arm group label: IMRT and concurrent cisplatin
  arm group label: Induction chemotherapy+IMRT and concurrent cisplatin
  intervention type: Drug
  intervention name: gemcitabine and cisplatin (Induction chemotherapy)
  description: Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy
  arm group label: Induction chemotherapy+IMRT and concurrent cisplatin
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Hai-Qiang Mai
  phone: 862087343643
  email: maihq@sysucc.org.cn
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Sun Yat-sen University
  investigator full name: Hai-Qiang Mai,MD,PhD
  investigator title: Professor
  mesh term: Carcinoma
  mesh term: Nasopharyngeal Carcinoma
  mesh term: Cisplatin
  mesh term: Gemcitabine