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/NCT06028412</url>
    </required_header>
    <id_info>
      <org_study_id>XKT-Y-20221121</org_study_id>
      <nct_id>NCT06028412</nct_id>
    </id_info>
    <brief_title>Comparison of Segmentectomy and Lobectomy in Small (2 cm or Less 0.5&lt;CTR&lt;1) Non-small Cell Lung Cancer: a Prospective, Multicenter Randomized Controlled Study</brief_title>
    <official_title>Comparison of Segmentectomy and Lobectomy in Small (2 cm or Less 0.5&lt;CTR&lt;1) Non-small Cell Lung Cancer: a Prospective, Multicenter Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Xiaolong Yan, Dr.</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tang-Du 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>
        The early NSCLC（Non-small cell lung cancer） patients with partial solid nodules mainly&#xD;
        composed of solid components, whose maximum tumor diameter was ≤ 2.0cm and&#xD;
        0.5&lt;CTR（Consolidation tumor ratio）&lt;1, as indicated by preoperative thin slice CT, were&#xD;
        selected as the study objects. The short-term and long-term effects of segmental resection&#xD;
        and lobectomy under Thoracoscopy were compared to provide high-level evidence for the&#xD;
        selection of surgical treatment methods for early NSCLC.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Since Cahan reported on &quot;radical lobectomy&quot; in 1960, lobectomy has become the standard&#xD;
        surgical method for lung cancer, and its efficacy has long been verified in clinical&#xD;
        practice. In 2006, the National Comprehensive Cancer Network (NCCN) lung cancer diagnosis and&#xD;
        treatment guidelines listed thoracoscopic lobectomy as one of the standard surgical methods&#xD;
        for early non-small cell lung cancer (NSCLC) for the first time. However, in recent years, an&#xD;
        increasing number of retrospective studies have found that the efficacy of subpulmonary&#xD;
        lobectomy in treating stage IA NSCLC is similar to that of lobectomy. Not only is there no&#xD;
        difference in survival rate, but perioperative complications and mortality are lower, and&#xD;
        lung function is also more protected. Anatomical segmental lung resection was also&#xD;
        recommended as one of the surgical options for early NSCLC patients by the US NCCN guidelines&#xD;
        in 2010. With the development of thin-layer CT diagnosis and treatment technology, the&#xD;
        detection rate of early lung cancer with main imaging manifestations such as small pulmonary&#xD;
        nodules and ground glass nodules (GGO) has improved. The solid components in GGO are often&#xD;
        considered as infiltrating components with a high possibility. The Lung Cancer Surgery&#xD;
        Research Group (LCSSG) of the Japanese Clinical Oncology Group used Solid Component Ratio for&#xD;
        ground glass nodules, which stratified the study population by the ratio of the maximum solid&#xD;
        component diameter to the maximum tumor diameter, and began multiple clinical trials related&#xD;
        to subpulmonary lobectomy, And these clinical trials will clarify whether subpulmonary&#xD;
        lobectomy can be used as a standard surgical procedure for early NSCLC patients.&#xD;
  &#xD;
        Among them, the recently released research results of the JCOG 0802 trial suggest that for&#xD;
        peripheral NSCLC with tumor diameter ≤ 2cm and CTR&gt;0.5, the segmental resection group even&#xD;
        outperforms the lobectomy group in terms of 5-year OS as the main endpoint, which overturns&#xD;
        people's understanding of early lung cancer surgery methods. The JCOG 0802 results showed&#xD;
        that the local recurrence rate in the segmental resection group was 10.5%, while in the&#xD;
        lobectomy group it was 5.4% (p=0.0018). However, the relatively high value of local&#xD;
        recurrence in the segmental resection group did not result in a decrease in the final 5-year&#xD;
        RFS and 5-year OS. And in the JCOG 0201 study, the tumor size of all recurrent cases within 5&#xD;
        and 10 years after surgery was ≥ 1cm, and the majority were patients with CTR=1.0. However,&#xD;
        it is worth noting that the JCOG 0802 experiment also has corresponding problems: 1. The&#xD;
        initial enrollment condition is CTR&gt;0.25, and with the release of the long-term results of&#xD;
        the JCOG 0201 experiment, the CTR value is adjusted from 0.25 to 0.5; 2. More than half of&#xD;
        the enrolled patients have pure solid nodules (CTR=1.0); 3. During the research phase,&#xD;
        preoperative 3D reconstruction technology was not used for surgical resection range planning.&#xD;
        Therefore, the experimental results of JCOG 0802 deserve further in-depth research, and the&#xD;
        choice of surgical methods for patients with partial solid nodules (PSN) with a diameter ≤&#xD;
        2cm and a CTR&lt;1 is also the most perplexing issue for thoracic surgeons at present. Someone&#xD;
        has proposed that for PSN patients with a diameter ≤ 2cm, subpulmonary lobectomy surgery can&#xD;
        replace traditional lobectomy surgery, and patients have similar prognosis. However, this&#xD;
        theory is derived from retrospective studies and there is a lack of relevant prospective&#xD;
        randomized controlled study data, which should be confirmed in prospective studies.&#xD;
        Therefore, the issues raised in the above research pose key scientific questions for the&#xD;
        implementation of this project: whether segmental resection of the lung has similar long-term&#xD;
        survival and short-term efficacy to lobectomy for patients with partial solid nodules with a&#xD;
        tumor diameter of ≤ 2cm and 0.5&lt;CTR&lt;1 requires a multicenter, prospective, non-inferiority,&#xD;
        randomized controlled study to answer.&#xD;
  &#xD;
        In summary, based on previous literature and clinical studies, this project conducted a&#xD;
        multicenter, prospective, open, non-inferiority, randomized controlled study in conjunction&#xD;
        with multiple well-known hospitals in China, targeting early NSCLC patients with partial&#xD;
        solid nodules (different from JCOG 0802, excluding solid nodules with CTR=1) with a maximum&#xD;
        tumor diameter of ≤ 2.0cm and a maximum tumor diameter of 0.5&lt;CTR&lt;1 on preoperative&#xD;
        thin-layer CT. The main endpoint of the study was 5-year DFS, Compare the short-term and&#xD;
        long-term efficacy of VATS pulmonary segment resection and lobectomy in the treatment of&#xD;
        early NSCLC. The expected results of this project will further fill the gaps in previous&#xD;
        clinical research and provide high-level evidence for the selection of surgical treatment&#xD;
        methods for early NSCLC. It is expected to enrich or rewrite the current surgical treatment&#xD;
        guidelines for lung cancer, improve the level of NSCLC surgical treatment, and have important&#xD;
        theoretical significance and practical value.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2030</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2029</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>DFS(Disease-free survival)</measure>
      <time_frame>Follow up for 5 years for all patients after enrollment</time_frame>
      <description>Disease-free survival (DFS) is a number that tells the chances of staying free of a disease or cancer after a particular treatment. It is the percentage of individuals in the treatment group who are likely to be free of the signs and symptoms of a disease after a specified duration of time.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>OS (Overall survival)</measure>
      <time_frame>Follow up for 5 years for all patients after enrollment</time_frame>
      <description>The time between the onset of randomization and the occurrence (progression) or death (for any reason) of the tumor.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pulmonary function test measure lung volume</measure>
      <time_frame>Respectively measure lung function at the 6th and 12th months after surgery</time_frame>
      <description>Pulmonary function test (PFTs) are noninvasive test that show how well the lungs are working after surgery.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pulmonary function test measure rates of flow</measure>
      <time_frame>Respectively measure lung function at the 6th and 12th months after surgery</time_frame>
      <description>Pulmonary function test (PFTs) are noninvasive test that show how well the lungs are working after surgery.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pulmonary function test measure gas exchange</measure>
      <time_frame>Respectively measure lung function at the 6th and 12th months after surgery</time_frame>
      <description>Pulmonary function test (PFTs) are noninvasive test that show how well the lungs are working after surgery.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">660</enrollment>
    <condition>NSCLC, Stage I</condition>
    <arm_group>
      <arm_group_label>Segmentectomy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>lobectomy</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Segmentectomy</intervention_name>
      <description>Patients in the lung segment group underwent anatomical segmental resection surgery, including subsegmental resection of the lung Patients in the lung segment group underwent anatomical segmental resection surgery, including subsegmental resection of the lung It is recommended to perform intraoperative lymph node sampling and rapid pathological examination (not mandatory). If lymph node metastasis is found during the surgery, the surgery must be switched to lobectomy. Lymph node sampling, selective lymph node dissection, or systematic lymph node dissection can also be used.</description>
      <arm_group_label>Segmentectomy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Lobectomy</intervention_name>
      <description>lobectomy</description>
      <arm_group_label>lobectomy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  nitial inclusion criteria:&#xD;
  &#xD;
                 1. Age 18-75 years old, regardless of gender;&#xD;
  &#xD;
                 2. ECOG PS score 0-1 points (Attachment 3.4);&#xD;
  &#xD;
                 3. Preoperative clinical staging for patients with suspected NSCLC lesions in Phase&#xD;
                    I (according to AJCC Eighth Edition staging standards, Attachment 3.5);&#xD;
  &#xD;
                 4. Thin slice CT indicates that the maximum tumor diameter is ≤ 2.0cm;&#xD;
  &#xD;
                 5. Pre operative CT prompts 0.5&lt;CTR&lt;1.0;&#xD;
  &#xD;
                 6. Good lung function (FEV1&gt;1.5 L or FEV1% ≥ 60%), able to tolerate both segmental&#xD;
                    resection and lobectomy;&#xD;
  &#xD;
                 7. The number of pulmonary nodules that need to be processed is ≤ 3, and the nodules&#xD;
                    are located in the same lobe of the lung;&#xD;
  &#xD;
                 8. Those who voluntarily sign the research informed consent form can comply with the&#xD;
                    research visit plan and other protocol requirements.&#xD;
  &#xD;
                    Exclusion Criteria:&#xD;
  &#xD;
          Initial exclusion criteria:&#xD;
  &#xD;
            1. Hypertension and diabetes difficult to control;&#xD;
  &#xD;
            2. Pregnant or lactating women;&#xD;
  &#xD;
            3. Those who have received anti-tumor treatment (radiotherapy, chemotherapy, Targeted&#xD;
               therapy, immunotherapy) before surgery;&#xD;
  &#xD;
            4. Previous history of lung surgery;&#xD;
  &#xD;
            5. Interstitial pneumonia, Pulmonary fibrosis or severe Emphysema;&#xD;
  &#xD;
            6. Those who undergo thoracotomy or change the surgical plan due to various reasons&#xD;
               during surgery;&#xD;
  &#xD;
            7. Severe mental illness;&#xD;
  &#xD;
            8. Individuals with a history of severe heart disease, heart failure, myocardial&#xD;
               infarction, or angina within the past 6 months;&#xD;
  &#xD;
            9. Active bacterial or fungal infections that are difficult to control;&#xD;
  &#xD;
           10. Individuals who have conducted other clinical trials in the three months prior to&#xD;
               enrollment.&#xD;
  &#xD;
          Secondary exclusion criteria:&#xD;
  &#xD;
            1. The postoperative pathological result was Benign tumor;&#xD;
  &#xD;
            2. Postoperative pathological results of non NSCLC malignant tumors;&#xD;
  &#xD;
            3. Non small cell lung cancer confirmed histologically during operation, but with&#xD;
               malignant Pleural effusion and pleural dissemination&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>xiaolong yan</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Second Affiliated Hospital of Air Force Medical University University of PLA</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>The Second Affiliated Hospital of Air Force Medical University University of PLA</name>
        <address>
          <city>Xi'an</city>
          <state>Shannxi</state>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Tang-Du Hospital</investigator_affiliation>
      <investigator_full_name>Xiaolong Yan, Dr.</investigator_full_name>
      <investigator_title>chief physician</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The official website of the Second Affiliated Hospital of the Air Force Military Medical University of PLA（http://tdwww.fmmu.edu.cn/）</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>2023 10years</ipd_time_frame>
    </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/NCT06028412
  org study id: XKT-Y-20221121
  nct id: NCT06028412
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The early NSCLC（Non-small cell lung cancer） patients with partial solid nodules mainly
        composed of solid components, whose maximum tumor diameter was ≤ 2.0cm and
        0.5<CTR（Consolidation tumor ratio）<1, as indicated by preoperative thin slice CT, were
        selected as the study objects. The short-term and long-term effects of segmental resection
        and lobectomy under Thoracoscopy were compared to provide high-level evidence for the
        selection of surgical treatment methods for early NSCLC.
  Since Cahan reported on "radical lobectomy" in 1960, lobectomy has become the standard
        surgical method for lung cancer, and its efficacy has long been verified in clinical
        practice. In 2006, the National Comprehensive Cancer Network (NCCN) lung cancer diagnosis and
        treatment guidelines listed thoracoscopic lobectomy as one of the standard surgical methods
        for early non-small cell lung cancer (NSCLC) for the first time. However, in recent years, an
        increasing number of retrospective studies have found that the efficacy of subpulmonary
        lobectomy in treating stage IA NSCLC is similar to that of lobectomy. Not only is there no
        difference in survival rate, but perioperative complications and mortality are lower, and
        lung function is also more protected. Anatomical segmental lung resection was also
        recommended as one of the surgical options for early NSCLC patients by the US NCCN guidelines
        in 2010. With the development of thin-layer CT diagnosis and treatment technology, the
        detection rate of early lung cancer with main imaging manifestations such as small pulmonary
        nodules and ground glass nodules (GGO) has improved. The solid components in GGO are often
        considered as infiltrating components with a high possibility. The Lung Cancer Surgery
        Research Group (LCSSG) of the Japanese Clinical Oncology Group used Solid Component Ratio for
        ground glass nodules, which stratified the study population by the ratio of the maximum solid
        component diameter to the maximum tumor diameter, and began multiple clinical trials related
        to subpulmonary lobectomy, And these clinical trials will clarify whether subpulmonary
        lobectomy can be used as a standard surgical procedure for early NSCLC patients.
  
        Among them, the recently released research results of the JCOG 0802 trial suggest that for
        peripheral NSCLC with tumor diameter ≤ 2cm and CTR>0.5, the segmental resection group even
        outperforms the lobectomy group in terms of 5-year OS as the main endpoint, which overturns
        people's understanding of early lung cancer surgery methods. The JCOG 0802 results showed
        that the local recurrence rate in the segmental resection group was 10.5%, while in the
        lobectomy group it was 5.4% (p=0.0018). However, the relatively high value of local
        recurrence in the segmental resection group did not result in a decrease in the final 5-year
        RFS and 5-year OS. And in the JCOG 0201 study, the tumor size of all recurrent cases within 5
        and 10 years after surgery was ≥ 1cm, and the majority were patients with CTR=1.0. However,
        it is worth noting that the JCOG 0802 experiment also has corresponding problems: 1. The
        initial enrollment condition is CTR>0.25, and with the release of the long-term results of
        the JCOG 0201 experiment, the CTR value is adjusted from 0.25 to 0.5; 2. More than half of
        the enrolled patients have pure solid nodules (CTR=1.0); 3. During the research phase,
        preoperative 3D reconstruction technology was not used for surgical resection range planning.
        Therefore, the experimental results of JCOG 0802 deserve further in-depth research, and the
        choice of surgical methods for patients with partial solid nodules (PSN) with a diameter ≤
        2cm and a CTR<1 is also the most perplexing issue for thoracic surgeons at present. Someone
        has proposed that for PSN patients with a diameter ≤ 2cm, subpulmonary lobectomy surgery can
        replace traditional lobectomy surgery, and patients have similar prognosis. However, this
        theory is derived from retrospective studies and there is a lack of relevant prospective
        randomized controlled study data, which should be confirmed in prospective studies.
        Therefore, the issues raised in the above research pose key scientific questions for the
        implementation of this project: whether segmental resection of the lung has similar long-term
        survival and short-term efficacy to lobectomy for patients with partial solid nodules with a
        tumor diameter of ≤ 2cm and 0.5<CTR<1 requires a multicenter, prospective, non-inferiority,
        randomized controlled study to answer.
  
        In summary, based on previous literature and clinical studies, this project conducted a
        multicenter, prospective, open, non-inferiority, randomized controlled study in conjunction
        with multiple well-known hospitals in China, targeting early NSCLC patients with partial
        solid nodules (different from JCOG 0802, excluding solid nodules with CTR=1) with a maximum
        tumor diameter of ≤ 2.0cm and a maximum tumor diameter of 0.5<CTR<1 on preoperative
        thin-layer CT. The main endpoint of the study was 5-year DFS, Compare the short-term and
        long-term efficacy of VATS pulmonary segment resection and lobectomy in the treatment of
        early NSCLC. The expected results of this project will further fill the gaps in previous
        clinical research and provide high-level evidence for the selection of surgical treatment
        methods for early NSCLC. It is expected to enrich or rewrite the current surgical treatment
        guidelines for lung cancer, improve the level of NSCLC surgical treatment, and have important
        theoretical significance and practical value.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: DFS(Disease-free survival)
  time frame: Follow up for 5 years for all patients after enrollment
  description: Disease-free survival (DFS) is a number that tells the chances of staying free of a disease or cancer after a particular treatment. It is the percentage of individuals in the treatment group who are likely to be free of the signs and symptoms of a disease after a specified duration of time.
  measure: OS (Overall survival)
  time frame: Follow up for 5 years for all patients after enrollment
  description: The time between the onset of randomization and the occurrence (progression) or death (for any reason) of the tumor.
  measure: Pulmonary function test measure lung volume
  time frame: Respectively measure lung function at the 6th and 12th months after surgery
  description: Pulmonary function test (PFTs) are noninvasive test that show how well the lungs are working after surgery.
  measure: Pulmonary function test measure rates of flow
  time frame: Respectively measure lung function at the 6th and 12th months after surgery
  description: Pulmonary function test (PFTs) are noninvasive test that show how well the lungs are working after surgery.
  measure: Pulmonary function test measure gas exchange
  time frame: Respectively measure lung function at the 6th and 12th months after surgery
  description: Pulmonary function test (PFTs) are noninvasive test that show how well the lungs are working after surgery.
  arm group label: Segmentectomy
  arm group type: Experimental
  arm group label: lobectomy
  arm group type: Placebo Comparator
  intervention type: Procedure
  intervention name: Segmentectomy
  description: Patients in the lung segment group underwent anatomical segmental resection surgery, including subsegmental resection of the lung Patients in the lung segment group underwent anatomical segmental resection surgery, including subsegmental resection of the lung It is recommended to perform intraoperative lymph node sampling and rapid pathological examination (not mandatory). If lymph node metastasis is found during the surgery, the surgery must be switched to lobectomy. Lymph node sampling, selective lymph node dissection, or systematic lymph node dissection can also be used.
  arm group label: Segmentectomy
  intervention type: Procedure
  intervention name: Lobectomy
  description: lobectomy
  arm group label: lobectomy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: xiaolong yan
  role: Principal Investigator
  affiliation: The Second Affiliated Hospital of Air Force Medical University University of PLA
  facility: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: Tang-Du Hospital
  investigator full name: Xiaolong Yan, Dr.
  investigator title: chief physician
  mesh term: Carcinoma, Non-Small-Cell Lung
  sharing ipd: Yes
  ipd description: The official website of the Second Affiliated Hospital of the Air Force Military Medical University of PLA（http://tdwww.fmmu.edu.cn/）
  ipd info type: Study Protocol
  ipd time frame: 2023 10years