<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/NCT03006575</url>
  </required_header>
  <id_info>
    <org_study_id>GASTO-1017</org_study_id>
    <nct_id>NCT03006575</nct_id>
  </id_info>
  <brief_title>Study of Split-course Chemoradiotherapy For Postoperative Locoregional Recurrence Of Non-small Cell Lung Cancer</brief_title>
  <official_title>A Prospective, Randomized, Phase Ⅱ Study of Split-course Chemoradiotherapy For Locoregional Recurrence Of Non-small Cell Lung Cancer After Surgical Resection</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>
  <brief_summary>
    <textblock>
      This Phase II randomized study is to determine the efficacy of split-course irradiation with&#xD;
      concurrent chemotherapy in locoregional recurrence of non-small cell lung cancer after&#xD;
      surgical resection&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This Phase II randomized study is to determine the efficacy of split-course irradiation with&#xD;
      concurrent chemotherapy in locoregional recurrence of non-small cell lung cancer after&#xD;
      surgical resection.&#xD;
&#xD;
      Patients received four cycles of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1&#xD;
      day's duration, combined with split-course thoracic radiotherapy of 40-51 Gy/10-17 fractions&#xD;
      and 15-24 Gy/5-8 fractions administered in the first and second courses, respectively, with&#xD;
      one-month break. The primary end point is progression-free survival, which is the time that&#xD;
      passes from the first day of radiotherapy to the date at which disease progresses.&#xD;
      Progression-free survival will be calculated using the Kaplan-Meier method.Toxicities will be&#xD;
      graded according to CTCAE v. 4.0.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 2015</start_date>
  <completion_date type="Anticipated">July 2021</completion_date>
  <primary_completion_date type="Actual">June 2020</primary_completion_date>
  <phase>Phase 2</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>progression-free survival</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response Rate</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of patients who develop local recurrence or distant recurrence</measure>
    <time_frame>2 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of grade 3-4 radiation pneumonitis/esophagitis evaluated by Common Terminology Criteria for Adverse Events Version 4.0</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">57</enrollment>
  <condition>Non-small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>split-course radiotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The radiotherapy is delivered using simultaneous integrated boost (SIB)-IMRT. Patients are irradiation at a palliative dose at the initial course: 40-51Gy/10-17f to PTV-GTV. The disease is re-evaluated one month after the end of the initial course using CT. The patient who achieved a partial remission according to the RECIST criteria and had a recovery of lung function should get the additional boost. At the second course, the tumor is repositioned and scanned. The residual tumor was then treated with the second course of radiotherapy. A dose of 15-24 Gy/5-8f is delivered to the residue tumor. Concurrent chemotherapy consists of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>split-course radiotherapy</intervention_name>
    <description>split-course chest radiation at 40-51 Gy/10-17f and 15-24 Gy/5-8f</description>
    <arm_group_label>split-course radiotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>concurrent chemotherapy</intervention_name>
    <description>weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡) concurrent with chest radiation</description>
    <arm_group_label>split-course radiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pathologic confirmation of NSCLC.&#xD;
&#xD;
          -  Patients have measurable or evaluable lesions based on the Response Evaluation&#xD;
             Criteria in Solid Tumors (RECIST) criteria.&#xD;
&#xD;
          -  Postoperative locoregional recurrence including ipsilateral hemithorax and the&#xD;
             mediastinum.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1.&#xD;
&#xD;
          -  Previously treated with chemotherapy or treatment-naive&#xD;
&#xD;
          -  No previous chest radiotherapy, immunotherapy or biotherapy&#xD;
&#xD;
          -  Hemoglobin≥10 mg/dL, platelet≥100000/μL,absolute neutrophil count ≥1500/μL&#xD;
&#xD;
          -  Serum creatinine ≤1.25 times the upper normal limit(UNL), or creatinine clearance≥60&#xD;
             ml/min&#xD;
&#xD;
          -  Bilirubin ≤1.5 times UNL, AST（SGOT）≤2.5 times UNL ,ALT（SGPT）≤2.5 times UNL,alkaline&#xD;
             phosphatase ≤5 times UNL&#xD;
&#xD;
          -  Forced expiratory volume at one second (FEV1) &gt;0.8 L&#xD;
&#xD;
          -  Coagulation tests within normal limits&#xD;
&#xD;
          -  patients and their family signed the informed consents&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous or recent another malignancy, except nonmelanoma skin cancer or cervical&#xD;
             cancer in situ&#xD;
&#xD;
          -  Second primary carcinoma of the lung&#xD;
&#xD;
          -  Contraindication for chemotherapy&#xD;
&#xD;
          -  Malignant pleural or pericardial effusion.&#xD;
&#xD;
          -  Women in pregnancy, lactation period, or no pregnancy test 14 days before the first&#xD;
             dos&#xD;
&#xD;
          -  Women who has the probability of pregnancy without contraception&#xD;
&#xD;
          -  Tendency of hemorrhage&#xD;
&#xD;
          -  In other clinical trials within 30 days&#xD;
&#xD;
          -  Addicted in drugs or alcohol, AIDS patients&#xD;
&#xD;
          -  Uncontrollable seizure or psychotic patients without self-control ability&#xD;
&#xD;
          -  Severe allergy or idiosyncrasy&#xD;
&#xD;
          -  Not suitable for this study judged by researchers&#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>Hui Liu, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sun yat-sen universtiy cancer center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bo Qiu, attending</last_name>
    <phone>+86-020-87343031</phone>
    <email>qiubo@sysucc.org.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hui Liu</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hui Liu, professor</last_name>
      <phone>+86-020-87343031</phone>
      <email>liuhui@sysucc.org.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
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    <citation>Begg AC, Hofland I, Van Glabekke M, et al. Predictive value of potential doubling time for radiotherapy of head and neck tumor pa- tients: results from the EORTC cooperative trial 22851. Semin Radiat Oncol 1992;2:22-25.</citation>
  </reference>
  <reference>
    <citation>Kim YS, Choi EK, Lee JS et al. Consolidation chemotherapy with monthly Paclitaxel and Cisplatin (PC) or observation after concurrent chemoradiotherapy for locally advanced non-small cell lung cancer (NSCLS): randomized phase II study. J Thorac Oncol 2007; 2:449s.</citation>
  </reference>
  <reference>
    <citation>Huber R, M, Engel-Riedel W, Kollmeier J et al. GILT study: oral vinorel- bine (NVBo) and cisplatin (P) with concomitant radiotherapy (RT) fol- lowed by either consolidation (C) with NVBo plus P plus best supportive care (BSC) or BSC alone in stage (st) III non-small cell lung cancer (NSCLC): final results of a phase (ph) III study. J Clin Oncol 2012;30: 452s (suppl, abstr 7001).</citation>
  </reference>
  <reference>
    <citation>Ahn JS, Ahn YC, Kim JH, Lee CG, Cho EK, Lee KC, Chen M, Kim DW, Kim HK, Min YJ, Kang JH, Choi JH, Kim SW, Zhu G, Wu YL, Kim SR, Lee KH, Song HS, Choi YL, Sun JM, Jung SH, Ahn MJ, Park K. Multinational Randomized Phase III Trial With or Without Consolidation Chemotherapy Using Docetaxel and Cisplatin After Concurrent Chemoradiation in Inoperable Stage III Non-Small-Cell Lung Cancer: KCSG-LU05-04. J Clin Oncol. 2015 Aug 20;33(24):2660-6. doi: 10.1200/JCO.2014.60.0130. Epub 2015 Jul 6.</citation>
    <PMID>26150444</PMID>
  </reference>
  <reference>
    <citation>Tsujino K, Kurata T, Yamamoto S, Kawaguchi T, Kubo A, Isa S, Hasegawa Y, Ou SH, Takada M, Ando M. Is consolidation chemotherapy after concurrent chemo-radiotherapy beneficial for patients with locally advanced non-small-cell lung cancer? A pooled analysis of the literature. J Thorac Oncol. 2013 Sep;8(9):1181-9. doi: 10.1097/JTO.0b013e3182988348.</citation>
    <PMID>23883782</PMID>
  </reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>April 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>January 15, 2021</last_update_submitted>
  <last_update_submitted_qc>January 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Hui Liu</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Non-small cell lung cancer</keyword>
  <keyword>Split-course Chemoradiotherapy</keyword>
  <keyword>Locoregional recurrence</keyword>
  <keyword>Postoperative recurrence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03006575
org study id: GASTO-1017
nct id: NCT03006575
lead sponsor: 
This Phase II randomized study is to determine the efficacy of split-course irradiation with
      concurrent chemotherapy in locoregional recurrence of non-small cell lung cancer after
      surgical resection
This Phase II randomized study is to determine the efficacy of split-course irradiation with
      concurrent chemotherapy in locoregional recurrence of non-small cell lung cancer after
      surgical resection.

      Patients received four cycles of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1
      day's duration, combined with split-course thoracic radiotherapy of 40-51 Gy/10-17 fractions
      and 15-24 Gy/5-8 fractions administered in the first and second courses, respectively, with
      one-month break. The primary end point is progression-free survival, which is the time that
      passes from the first day of radiotherapy to the date at which disease progresses.
      Progression-free survival will be calculated using the Kaplan-Meier method.Toxicities will be
      graded according to CTCAE v. 4.0.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: progression-free survival
time frame: 2 years
measure: Overall Survival
time frame: 2 years
measure: Response Rate
time frame: 2 years
measure: rate of patients who develop local recurrence or distant recurrence
time frame: 2 year
measure: rate of grade 3-4 radiation pneumonitis/esophagitis evaluated by Common Terminology Criteria for Adverse Events Version 4.0
time frame: 1 year
arm group label: split-course radiotherapy
arm group type: Experimental
description: The radiotherapy is delivered using simultaneous integrated boost (SIB)-IMRT. Patients are irradiation at a palliative dose at the initial course: 40-51Gy/10-17f to PTV-GTV. The disease is re-evaluated one month after the end of the initial course using CT. The patient who achieved a partial remission according to the RECIST criteria and had a recovery of lung function should get the additional boost. At the second course, the tumor is repositioned and scanned. The residual tumor was then treated with the second course of radiotherapy. A dose of 15-24 Gy/5-8f is delivered to the residue tumor. Concurrent chemotherapy consists of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration.
intervention type: Radiation
intervention name: split-course radiotherapy
description: split-course chest radiation at 40-51 Gy/10-17f and 15-24 Gy/5-8f
arm group label: split-course radiotherapy
intervention type: Drug
intervention name: concurrent chemotherapy
description: weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡) concurrent with chest radiation
arm group label: split-course radiotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Hui Liu, professor
role: Principal Investigator
affiliation: Sun yat-sen universtiy cancer center
last name: Bo Qiu, attending
phone: +86-020-87343031
email: qiubo@sysucc.org.cn
facility: 
status: Recruiting
contact: 
country: China
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citation: Kim YS, Choi EK, Lee JS et al. Consolidation chemotherapy with monthly Paclitaxel and Cisplatin (PC) or observation after concurrent chemoradiotherapy for locally advanced non-small cell lung cancer (NSCLS): randomized phase II study. J Thorac Oncol 2007; 2:449s.
citation: Huber R, M, Engel-Riedel W, Kollmeier J et al. GILT study: oral vinorel- bine (NVBo) and cisplatin (P) with concomitant radiotherapy (RT) fol- lowed by either consolidation (C) with NVBo plus P plus best supportive care (BSC) or BSC alone in stage (st) III non-small cell lung cancer (NSCLC): final results of a phase (ph) III study. J Clin Oncol 2012;30: 452s (suppl, abstr 7001).
citation: Ahn JS, Ahn YC, Kim JH, Lee CG, Cho EK, Lee KC, Chen M, Kim DW, Kim HK, Min YJ, Kang JH, Choi JH, Kim SW, Zhu G, Wu YL, Kim SR, Lee KH, Song HS, Choi YL, Sun JM, Jung SH, Ahn MJ, Park K. Multinational Randomized Phase III Trial With or Without Consolidation Chemotherapy Using Docetaxel and Cisplatin After Concurrent Chemoradiation in Inoperable Stage III Non-Small-Cell Lung Cancer: KCSG-LU05-04. J Clin Oncol. 2015 Aug 20;33(24):2660-6. doi: 10.1200/JCO.2014.60.0130. Epub 2015 Jul 6.
PMID: 26150444
citation: Tsujino K, Kurata T, Yamamoto S, Kawaguchi T, Kubo A, Isa S, Hasegawa Y, Ou SH, Takada M, Ando M. Is consolidation chemotherapy after concurrent chemo-radiotherapy beneficial for patients with locally advanced non-small-cell lung cancer? A pooled analysis of the literature. J Thorac Oncol. 2013 Sep;8(9):1181-9. doi: 10.1097/JTO.0b013e3182988348.
PMID: 23883782
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Hui Liu
investigator title: Professor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Recurrence
sharing ipd: Undecided