<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/NCT01664663</url>
  </required_header>
  <id_info>
    <org_study_id>PLANET</org_study_id>
    <nct_id>NCT01664663</nct_id>
  </id_info>
  <brief_title>Phase II Randomized Study on Locally Advanced NSCLC Escalated Dose on Individual Basis Treatment With Radiochemotherapy</brief_title>
  <acronym>PLANET</acronym>
  <official_title>Phase II Randomized Study on Locally Advanced Non Small Cell Lung Cancer Escalated Dose on Individual Basis Treatment With Radiochemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ass. Prof. Jan Nyman</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Swedish Lung Cancer Study Group</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine the valu of individually dose escalated radiotherapy&#xD;
      compared with a standard dose of radiotherapy combined with standard concomitant chemotherapy&#xD;
      for patients with locally advanced non small cell lung cancer (stage III) with good&#xD;
      performance status.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open label, multicentre phase II trial of individually escalated radiotherapy up&#xD;
      to 84 Gy due to normal tissue dose constraints combined with standard concurrent chemotherapy&#xD;
      (cisplatin-vinorelbine) compared to standard dose radiotherapy (68 Gy) combined with the same&#xD;
      chemotherapy. There are restrictions due to lung function, performance status and&#xD;
      pre-treatment weight loss. The main endpoint is progression free survival and additional&#xD;
      endpoints are local control, overall survival, toxicity quality of life and relapse pattern.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Safety analysis showed increased grade 5 toxicity in experimental arm.&#xD;
  </why_stopped>
  <start_date>September 2011</start_date>
  <completion_date type="Anticipated">October 2015</completion_date>
  <primary_completion_date type="Actual">November 2013</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>36 monts after randomization</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Numbers of patients without progression of locoregional disease</measure>
    <time_frame>36 months after randomization</time_frame>
    <description>Measured with CT-scan according to the RECIST criteria for response</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Overall survival</measure>
    <time_frame>36 months after randomization</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Numbers of patients with adverse events</measure>
    <time_frame>Up to 36 months after randomization</time_frame>
    <description>According to CTC version 4.0</description>
  </other_outcome>
  <other_outcome>
    <measure>Quality of life</measure>
    <time_frame>Up to 36 months after randomization</time_frame>
    <description>Measured by questionaires, EORTC QLQ 30 + LC 14</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Non Small Cell Lung Cancer</condition>
  <condition>Locally Advanced Disease</condition>
  <arm_group>
    <arm_group_label>Arm A:Standard radiochemotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Radiotherapy with 2 Gy per fractions 5 fractions a week to 68 Gy to the planning target volume. Three courses of cisplatin 75 mg/m2 day 1and vinorelbine 25 mg/m2 day 1+8. Two courses concomitant with radiation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B Escalated radiochemotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Radiotherapy with 2 Gy per fraction 5 or 6 times a week to 68-84 Gy to the planning target volume due to normal tissue tolerance constraints. Dose to lung tissue, esophagus and spinal cord will be considered. Three courses of cisplatin 75 mg/m2 day 1 and vinorelbine 25 mg/m2 day 1+8 will be given, two courses concomitant with radiation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Standard radiochemotherapy to 68 Gy</intervention_name>
    <arm_group_label>Arm A:Standard radiochemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Dose escalated radiochemotherapy up to 84 Gy</intervention_name>
    <arm_group_label>Arm B Escalated radiochemotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological or cytological diagnosis of NSCLC stage IIIA-B.&#xD;
&#xD;
          -  Nonresectable or medically inoperable patients.&#xD;
&#xD;
          -  No prior chemo- or radiotherapy for NSCLC.&#xD;
&#xD;
          -  PS 0-1.&#xD;
&#xD;
          -  FEV1 &gt; 1 l or &gt; 40% and CO diffusion capacity &gt; 40%.&#xD;
&#xD;
          -  Patient compliance and geographic proximity that allow adequate follow-up.&#xD;
&#xD;
          -  Adequate bone marrow reserve: WBCC &gt;3.0, platelets &gt;100, haemoglobin &gt; 100.&#xD;
&#xD;
          -  Written informed concent.&#xD;
&#xD;
          -  Effective use of contraception.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Excessive weight loss within 6 months (&gt; 10%).&#xD;
&#xD;
          -  Supraclavicular nodes.&#xD;
&#xD;
          -  Apical tumors-pancoast.&#xD;
&#xD;
          -  T4 tumors with separate manifestations in different lobes.&#xD;
&#xD;
          -  Evidence of active serious infections.&#xD;
&#xD;
          -  Inadequate liver function.&#xD;
&#xD;
          -  Inadequate kidney function.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Breast feeding.&#xD;
&#xD;
          -  Serious concomitant systemic disorder.&#xD;
&#xD;
          -  Second primary malignancy the last 5 years.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jan Nyman, Ass. prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Swedish Lung Cancer Study Group</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Oncology, Norrlands Universitetssjukhus</name>
      <address>
        <city>Umeå</city>
        <state>Norrland</state>
        <zip>901 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Oncology, Karolinska University Hospital</name>
      <address>
        <city>Stockholm</city>
        <state>Stockholm county</state>
        <zip>171 76</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Oncology, Sahlgrenska University Hospital</name>
      <address>
        <city>Gothenburg</city>
        <state>Västra Götaland</state>
        <zip>413 45</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <last_update_submitted>December 8, 2014</last_update_submitted>
  <last_update_submitted_qc>December 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Swedish Lung Cancer Study Group</investigator_affiliation>
    <investigator_full_name>Ass. Prof. Jan Nyman</investigator_full_name>
    <investigator_title>Assosiated professor Jan Nyman, Department of Oncology, Sahlgrenska University Hospital, Gotenburg , Sweden</investigator_title>
  </responsible_party>
  <keyword>Radiotherapy</keyword>
  <keyword>Dose escalation</keyword>
  <keyword>Normal tissue constraints</keyword>
  <keyword>Locally advanced disease</keyword>
  <keyword>Good performance status</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>
  </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/NCT01664663
org study id: PLANET
nct id: NCT01664663
lead sponsor: 
has dmc: Yes
The purpose of this study is to examine the valu of individually dose escalated radiotherapy
      compared with a standard dose of radiotherapy combined with standard concomitant chemotherapy
      for patients with locally advanced non small cell lung cancer (stage III) with good
      performance status.
This is an open label, multicentre phase II trial of individually escalated radiotherapy up
      to 84 Gy due to normal tissue dose constraints combined with standard concurrent chemotherapy
      (cisplatin-vinorelbine) compared to standard dose radiotherapy (68 Gy) combined with the same
      chemotherapy. There are restrictions due to lung function, performance status and
      pre-treatment weight loss. The main endpoint is progression free survival and additional
      endpoints are local control, overall survival, toxicity quality of life and relapse pattern.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression free survival
time frame: 36 monts after randomization
measure: Numbers of patients without progression of locoregional disease
time frame: 36 months after randomization
description: Measured with CT-scan according to the RECIST criteria for response
measure: Overall survival
time frame: 36 months after randomization
measure: Numbers of patients with adverse events
time frame: Up to 36 months after randomization
description: According to CTC version 4.0
measure: Quality of life
time frame: Up to 36 months after randomization
description: Measured by questionaires, EORTC QLQ 30 + LC 14
arm group label: Arm A:Standard radiochemotherapy
arm group type: Active Comparator
description: Radiotherapy with 2 Gy per fractions 5 fractions a week to 68 Gy to the planning target volume. Three courses of cisplatin 75 mg/m2 day 1and vinorelbine 25 mg/m2 day 1+8. Two courses concomitant with radiation.
arm group label: Arm B Escalated radiochemotherapy
arm group type: Experimental
description: Radiotherapy with 2 Gy per fraction 5 or 6 times a week to 68-84 Gy to the planning target volume due to normal tissue tolerance constraints. Dose to lung tissue, esophagus and spinal cord will be considered. Three courses of cisplatin 75 mg/m2 day 1 and vinorelbine 25 mg/m2 day 1+8 will be given, two courses concomitant with radiation.
intervention type: Radiation
intervention name: Standard radiochemotherapy to 68 Gy
arm group label: Arm A:Standard radiochemotherapy
intervention type: Radiation
intervention name: Dose escalated radiochemotherapy up to 84 Gy
arm group label: Arm B Escalated radiochemotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jan Nyman, Ass. prof
role: Principal Investigator
affiliation: Swedish Lung Cancer Study Group
facility: 
facility: 
facility: 
country: Sweden
responsible party type: Sponsor-Investigator
investigator affiliation: Swedish Lung Cancer Study Group
investigator full name: Ass. Prof. Jan Nyman
investigator title: Assosiated professor Jan Nyman, Department of Oncology, Sahlgrenska University Hospital, Gotenburg , Sweden
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung