<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/NCT01667302</url>
  </required_header>
  <id_info>
    <org_study_id>LMTG 12-02</org_study_id>
    <nct_id>NCT01667302</nct_id>
  </id_info>
  <brief_title>Radiotherapy Followed by Adjuvant Chemotherapy in NK/T-cell Lymphoma</brief_title>
  <official_title>A Phase II Study of Radiotherapy Followed by Chemotherapy With DICEP Regimen in Patients With NK/T-cell Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fudan University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy and tolerability of radiotherapy&#xD;
      followed by adjuvant chemotherapy in stage I/II NK/T-cell lymphoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For patients with stage I/II NK/T-cell lymphoma, the sequence of radiotherapy and&#xD;
      chemotherapy is controversial. Some studies demonstrated the advantage of upfront&#xD;
      radiotherapy. Therefore, we designed this single-arm phase II study to evaluate the efficacy&#xD;
      and safety of radiotherapy followed by adjuvant chemotherapy with DICE regimen plus&#xD;
      peg-asparaginase which was proved to be effective in NK/T-cell lymphoma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2012</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2013</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>3-year Progression-free survival</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall response rate</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-year overall survival</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Extranodal NK/T-cell Lymphoma, Nasal Type</condition>
  <arm_group>
    <arm_group_label>Radiotherapy followed by chemotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Radiotherapy Technique: IMRT Total dose: 50 Gy Per fraction: 2 Gy Chemotherapy: q3w Dexamethasone 40 mg d1-4 Ifosfamide 1200mg/m2 d1-4 Etoposide 60 mg/m2 d1-4 Cisplatin 20mg/m2 d1-4 Peg-asparaginase 2000 IU/m2 d1</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Radiotherapy followed by chemotherapy</intervention_name>
    <description>Radiotherapy Technique: IMRT Total dose: 50 Gy Per fraction: 2 Gy Chemotherapy: q3w Dexamethasone 40 mg d1-4 Ifosfamide 1200mg/m2 d1-4 Etoposide 60 mg/m2 d1-4 Cisplatin 20mg/m2 d1-4 Peg-asparaginase 2000 IU/m2 d1</description>
    <arm_group_label>Radiotherapy followed by chemotherapy</arm_group_label>
    <other_name>DXM, IFO, VP-16, DDP, PEG-ASP</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age range 14-70 years old&#xD;
&#xD;
          -  Histological confirmed, previously untreated stage I/II NK/T cell lymphoma in the&#xD;
             upper-aerodigestive tract&#xD;
&#xD;
          -  ECOG performance status 0-1&#xD;
&#xD;
          -  Life expectancy of more than 3 months&#xD;
&#xD;
          -  Without prior history of pancreatitis&#xD;
&#xD;
          -  Adequate bone marrow and organ functions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Low risk population (Definition: stage I without local invasion, B symptoms and high&#xD;
             LDH level)&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  With contraindication of steroid including uncontrolled diabetes&#xD;
&#xD;
          -  Serious uncontrolled diseases and intercurrent infection&#xD;
&#xD;
          -  History of other malignancies except cured basal cell carcinoma of skin and carcinoma&#xD;
             in-situ of uterine cervix&#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>Ye Guo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ye Guo, MD</last_name>
    <phone>862164175590</phone>
    <email>pattrick_guo@msn.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Fudan University Cancer Hospital</name>
      <address>
        <city>SHanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ye Guo, MD</last_name>
      <phone>862164175590</phone>
      <email>pattrick_guo@msn.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2013</verification_date>
  <study_first_submitted>August 13, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>March 2, 2013</last_update_submitted>
  <last_update_submitted_qc>March 2, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 5, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Ye Guo</investigator_full_name>
    <investigator_title>Assocaite Director of Medical Oncology Department</investigator_title>
  </responsible_party>
  <keyword>NK/T-cell lymphoma</keyword>
  <keyword>Radiotherapy</keyword>
  <keyword>Adjuvant chemotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, T-Cell</mesh_term>
    <mesh_term>Lymphoma, T-Cell, Peripheral</mesh_term>
    <mesh_term>Lymphoma, Extranodal NK-T-Cell</mesh_term>
  </condition_browse>
  <!-- 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/NCT01667302
org study id: LMTG 12-02
nct id: NCT01667302
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the efficacy and tolerability of radiotherapy
      followed by adjuvant chemotherapy in stage I/II NK/T-cell lymphoma.
For patients with stage I/II NK/T-cell lymphoma, the sequence of radiotherapy and
      chemotherapy is controversial. Some studies demonstrated the advantage of upfront
      radiotherapy. Therefore, we designed this single-arm phase II study to evaluate the efficacy
      and safety of radiotherapy followed by adjuvant chemotherapy with DICE regimen plus
      peg-asparaginase which was proved to be effective in NK/T-cell lymphoma.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 3-year Progression-free survival
time frame: 3 years
measure: Overall response rate
time frame: 3 years
measure: 3-year overall survival
time frame: 3 years
measure: Safety
time frame: 3 years
arm group label: Radiotherapy followed by chemotherapy
arm group type: Experimental
description: Radiotherapy Technique: IMRT Total dose: 50 Gy Per fraction: 2 Gy Chemotherapy: q3w Dexamethasone 40 mg d1-4 Ifosfamide 1200mg/m2 d1-4 Etoposide 60 mg/m2 d1-4 Cisplatin 20mg/m2 d1-4 Peg-asparaginase 2000 IU/m2 d1
intervention type: Drug
intervention name: Radiotherapy followed by chemotherapy
description: Radiotherapy Technique: IMRT Total dose: 50 Gy Per fraction: 2 Gy Chemotherapy: q3w Dexamethasone 40 mg d1-4 Ifosfamide 1200mg/m2 d1-4 Etoposide 60 mg/m2 d1-4 Cisplatin 20mg/m2 d1-4 Peg-asparaginase 2000 IU/m2 d1
arm group label: Radiotherapy followed by chemotherapy
other name: DXM, IFO, VP-16, DDP, PEG-ASP
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Ye Guo, MD
role: Principal Investigator
affiliation: Fudan University
last name: Ye Guo, MD
phone: 862164175590
email: pattrick_guo@msn.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Ye Guo
investigator title: Assocaite Director of Medical Oncology Department
mesh term: Lymphoma
mesh term: Lymphoma, T-Cell
mesh term: Lymphoma, T-Cell, Peripheral
mesh term: Lymphoma, Extranodal NK-T-Cell