<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/NCT03290820</url>
  </required_header>
  <id_info>
    <org_study_id>2017-FXY-067</org_study_id>
    <nct_id>NCT03290820</nct_id>
  </id_info>
  <brief_title>Aspirin Improve Survival of N2-3 Nasopharyngeal Carcinoma Patients</brief_title>
  <official_title>Aspirin Improve Survival of Patients With N2-3 Nasopharyngeal Carcinoma: A Phase 2 Prospective Randomized 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>
      Nasopharyngeal carcinoma (NPC) is one of the most common maligancies of China. In the era of&#xD;
      intensity-modulated radiotherapy (IMRT), the 5-year overall survival (OS) has now reached&#xD;
      85.0% or more. However, even after chemoradiation, the 5-year distant-metastasis rate of&#xD;
      patients with N2-3 NPC is still 36.7%. Aspirin is proven in lab and clinical studies to have&#xD;
      the abilities of inhibiting the inflammation which could enhance metastasis of breast and&#xD;
      colorectal cancers. And before this study, it was discovered that regular aspirin intake&#xD;
      might be associated with distant-metastasis-free survival (MFS) and OS independently. So this&#xD;
      Phase 2 trial was conducted to validate the impact of aspirin on prognosis of N2-3 NPC.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nasopharyngeal carcinoma (NPC) is one of the most common maligancies of China. In the era of&#xD;
      intensity-modulated radiotherapy (IMRT), the 5-year overall survival (OS) has now reached&#xD;
      85.0% or more. However, the prognosis of the patients with late N (N2-3) diseases remains&#xD;
      poor. Even after chemoradiation, the 5-year distant-metastasis rate of these patients is&#xD;
      nearly 36.7%. Additionally, these patients occupies about 30.0% of the whole NPC population.&#xD;
      To improve the prognosis of the patients with N2-3 NPC, there is a need to explore a new,&#xD;
      practical and effective method to eliminate the distant metastasis.&#xD;
&#xD;
      Aspirin is proven in lab and clinical studies to have the abilities of inhibiting the&#xD;
      inflammation which could enhance metastasis of many malignant tumors, such as breast and&#xD;
      colorectal cancers. And before this study, patients with N2-3 nonmetastatic NPC between 2008&#xD;
      and 2011 were retrospectively analyzed, to discovered that regular aspirin intake might be&#xD;
      associated with distant-metastasis-free survival (MFS) and OS independently. So this Phase 2&#xD;
      randomized controlled trial was conducted to validate the impact of aspirin on prognosis of&#xD;
      N2-3 NPC.&#xD;
&#xD;
      This study aim to enroll patients with T1-4N2-3M0 NPC. All the patients will be treated with&#xD;
      IMRT and concurrent chemotherapy of the PF (Nedaplatin + 5-flurouracil) regimen. After&#xD;
      randomization, patients in the Experimental Group will also receive daily aspirin of 75mg.&#xD;
      The 5-year MFS is the primary endpoint. And the 5-year OS and aspirin-related toxicities are&#xD;
      the secondary endponits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">January 1, 2018</start_date>
  <completion_date type="Anticipated">September 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2024</primary_completion_date>
  <phase>Phase 2</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 patients eligible are divided randomly. All the patients will receive concurrent chemoradiotherapy. The cases in the Experimental Group will receive daily aspirin of 75mg.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Distant-metastasis-free survival</measure>
    <time_frame>5 years after diagnosis</time_frame>
    <description>The percentage of patients of a data set who survive without distant metastasis after a defined period of time from pathologic diagnosis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>5 years after diagnosis</time_frame>
    <description>The percentage of patients of a data set who survive after a defined period of time from pathologic diagnosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aspirin-related toxicities</measure>
    <time_frame>5 years after diagnosis</time_frame>
    <description>Incidence of aspirin-related toxicities such as gastrointestinal bleeding and liver dysfunction</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">184</enrollment>
  <condition>Nasopharyngeal Carcinoma</condition>
  <arm_group>
    <arm_group_label>Controlled Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients in the Controlled Group are allocated to receive radiotherapy and concurrent chemotherapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients in the Experimental Group are allocated to receive radiotherapy and concurrent chemotherapy plus daily aspirin.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiotherapy</intervention_name>
    <description>Technique: intensity-modulated radiotherapy; Dose: GTVnx 6810cGy/30Fr, GTVnd 6400-6600cGy/30Fr, CTV1 6000cGy, CTV2 5400cGy.</description>
    <arm_group_label>Controlled Group</arm_group_label>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Concurrent chemotherapy</intervention_name>
    <description>Nedaplatin 80mg/m2 d1+5-flurouracil 500mg/m2 d2-5, every 3 weeks; a total of 2-3 cycles.</description>
    <arm_group_label>Controlled Group</arm_group_label>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aspirin</intervention_name>
    <description>Daily aspirin of 75mg, from the starting date of radiotherapy.</description>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pathologic dianosis of nasopharyngeal carcinoma&#xD;
&#xD;
          -  Stage of T1-4N2-3M0 (UICC/AJCC classification ver. 7)&#xD;
&#xD;
          -  18-70 years old&#xD;
&#xD;
          -  Karnofsky performance score &gt; 70&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Distant metastasis before or during radiotherapy&#xD;
&#xD;
          -  Severe dysfunctions of liver, kidney, lung, heart of bone marrow which are not fit for&#xD;
             radiotherapy&#xD;
&#xD;
          -  Prior malignancies&#xD;
&#xD;
          -  Prior history of radiotherapy, chemotherapy or monoclonal antibody therapy&#xD;
&#xD;
          -  Participation of other drug trials within 3 months&#xD;
&#xD;
          -  Regular use of aspirin before dianosis&#xD;
&#xD;
          -  Contraindication or allergy of aspirin&#xD;
&#xD;
          -  Patients who are considered by the researchers not suitable to participate this trial&#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_official>
    <last_name>Yun-fei Xia, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sun Yat-sen University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yun-fei Xia, M.D</last_name>
    <phone>86-13602805461</phone>
    <email>xiayf@sysucc.org.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hui Chang, M.D</last_name>
    <phone>86-020-87343374</phone>
    <email>changhui@sysucc.org.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sun Yat-sen University Cancer Center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Hui Chang, M.D</last_name>
      <phone>86-020-87343374</phone>
      <email>changhui@sysucc.org.cn</email>
    </contact>
    <contact_backup>
      <last_name>Chen Chen, M.D</last_name>
      <email>chenchen@sysucc.org.cn</email>
    </contact_backup>
    <investigator>
      <last_name>Yun-fei Xia, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>October 25, 2017</last_update_submitted>
  <last_update_submitted_qc>October 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Yun-fei Xia</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>nasopharyngeal carcinoma</keyword>
  <keyword>N2-3 disease</keyword>
  <keyword>distant metastasis</keyword>
  <keyword>aspirin</keyword>
  <keyword>survival</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>Aspirin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03290820
org study id: 2017-FXY-067
nct id: NCT03290820
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Nasopharyngeal carcinoma (NPC) is one of the most common maligancies of China. In the era of
      intensity-modulated radiotherapy (IMRT), the 5-year overall survival (OS) has now reached
      85.0% or more. However, even after chemoradiation, the 5-year distant-metastasis rate of
      patients with N2-3 NPC is still 36.7%. Aspirin is proven in lab and clinical studies to have
      the abilities of inhibiting the inflammation which could enhance metastasis of breast and
      colorectal cancers. And before this study, it was discovered that regular aspirin intake
      might be associated with distant-metastasis-free survival (MFS) and OS independently. So this
      Phase 2 trial was conducted to validate the impact of aspirin on prognosis of N2-3 NPC.
Nasopharyngeal carcinoma (NPC) is one of the most common maligancies of China. In the era of
      intensity-modulated radiotherapy (IMRT), the 5-year overall survival (OS) has now reached
      85.0% or more. However, the prognosis of the patients with late N (N2-3) diseases remains
      poor. Even after chemoradiation, the 5-year distant-metastasis rate of these patients is
      nearly 36.7%. Additionally, these patients occupies about 30.0% of the whole NPC population.
      To improve the prognosis of the patients with N2-3 NPC, there is a need to explore a new,
      practical and effective method to eliminate the distant metastasis.

      Aspirin is proven in lab and clinical studies to have the abilities of inhibiting the
      inflammation which could enhance metastasis of many malignant tumors, such as breast and
      colorectal cancers. And before this study, patients with N2-3 nonmetastatic NPC between 2008
      and 2011 were retrospectively analyzed, to discovered that regular aspirin intake might be
      associated with distant-metastasis-free survival (MFS) and OS independently. So this Phase 2
      randomized controlled trial was conducted to validate the impact of aspirin on prognosis of
      N2-3 NPC.

      This study aim to enroll patients with T1-4N2-3M0 NPC. All the patients will be treated with
      IMRT and concurrent chemotherapy of the PF (Nedaplatin + 5-flurouracil) regimen. After
      randomization, patients in the Experimental Group will also receive daily aspirin of 75mg.
      The 5-year MFS is the primary endpoint. And the 5-year OS and aspirin-related toxicities are
      the secondary endponits.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The patients eligible are divided randomly. All the patients will receive concurrent chemoradiotherapy. The cases in the Experimental Group will receive daily aspirin of 75mg.
primary purpose: Treatment
masking: None (Open Label)
measure: Distant-metastasis-free survival
time frame: 5 years after diagnosis
description: The percentage of patients of a data set who survive without distant metastasis after a defined period of time from pathologic diagnosis
measure: Overall survival
time frame: 5 years after diagnosis
description: The percentage of patients of a data set who survive after a defined period of time from pathologic diagnosis
measure: Aspirin-related toxicities
time frame: 5 years after diagnosis
description: Incidence of aspirin-related toxicities such as gastrointestinal bleeding and liver dysfunction
arm group label: Controlled Group
arm group type: Active Comparator
description: The patients in the Controlled Group are allocated to receive radiotherapy and concurrent chemotherapy.
arm group label: Experimental Group
arm group type: Experimental
description: The patients in the Experimental Group are allocated to receive radiotherapy and concurrent chemotherapy plus daily aspirin.
intervention type: Radiation
intervention name: Radiotherapy
description: Technique: intensity-modulated radiotherapy; Dose: GTVnx 6810cGy/30Fr, GTVnd 6400-6600cGy/30Fr, CTV1 6000cGy, CTV2 5400cGy.
arm group label: Controlled Group
arm group label: Experimental Group
intervention type: Drug
intervention name: Concurrent chemotherapy
description: Nedaplatin 80mg/m2 d1+5-flurouracil 500mg/m2 d2-5, every 3 weeks; a total of 2-3 cycles.
arm group label: Controlled Group
arm group label: Experimental Group
intervention type: Drug
intervention name: Aspirin
description: Daily aspirin of 75mg, from the starting date of radiotherapy.
arm group label: Experimental Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Yun-fei Xia, M.D
role: Principal Investigator
affiliation: Sun Yat-sen University
last name: Yun-fei Xia, M.D
phone: 86-13602805461
email: xiayf@sysucc.org.cn
last name: Hui Chang, M.D
phone: 86-020-87343374
email: changhui@sysucc.org.cn
facility: 
contact: 
contact backup: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Yun-fei Xia
investigator title: Professor
mesh term: Carcinoma
mesh term: Nasopharyngeal Carcinoma
mesh term: Aspirin
sharing ipd: No