<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/NCT02216617</url>
  </required_header>
  <id_info>
    <org_study_id>GORTEC 2013-01</org_study_id>
    <secondary_id>2013-002876-42</secondary_id>
    <nct_id>NCT02216617</nct_id>
  </id_info>
  <brief_title>Evaluation of the Tolerance of Afatinib in Combination With Docetaxel and Cisplatin in LAHNSCC Induction Chemotherapy</brief_title>
  <acronym>TAPIS</acronym>
  <official_title>A Phase I Study Evaluating the Combination Afatinib With Docetaxel and Cisplatin (TPA) in Induction Chemotherapy in Locally Advanced Squamous Cell Carcinoma of the Upper Aerodigestive Tract</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Groupe Oncologie Radiotherapie Tete et Cou</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Groupe Oncologie Radiotherapie Tete et Cou</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to determine the maximum tolerated dose (MTD) of afatinib&#xD;
      administrated in combination with docetaxel (Taxotere®) and cisplatin in induction&#xD;
      chemotherapy of locally advanced head and neck carcinoma in order to move to a phase II,&#xD;
      allowing the comparison with standard induction chemotherapy TPF.&#xD;
&#xD;
      It is a multicentric, national, opened, not-randomized phase Ib. Three doses of afatinib (20,&#xD;
      30 and 40 Mg per day) will be studied in combination with the fixed standard doses of&#xD;
      docetaxel and cisplatin. For each dose level, beginning with smallest (20 Mg per day of&#xD;
      afatinib), 3 to 6 patients will be treated at maximum, i.e. 3 cycles of three weeks treatment&#xD;
      each one (9 weeks on the whole). The next dose level will be studied only if the previous&#xD;
      dose is well tolerated for the period of the first 4 weeks observation of the treatment (1st&#xD;
      cycle more first week of the 2nd cycle). Once the MTD is determined, four additional patients&#xD;
      will be treated with this dose. A maximum of 22 patients should be included in this study.&#xD;
      The total duration of the study is estimated at 18 months. In case of major safety problems,&#xD;
      the study may be stopped earlier. In short, the preclinical data, pharmacological and&#xD;
      clinical on afatinib indicate that the benefit-risk ratio can be regarded as positive and&#xD;
      that the association of afatinib with cisplatin and docetaxel could be effective in patients&#xD;
      with head and neck squamous cell carcinoma potentially resulting in an extension of time to&#xD;
      progression.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cancers of the upper aerodigestive tract correspond in the Western countries about 5% of&#xD;
      cancers. They are treated by surgery, radiotherapy, and chemotherapy. Although progress in&#xD;
      radio chemotherapy have reduced mortality and increase the rates of organ preservation in&#xD;
      patients with locally advanced head and neck cancers, they have metastatic risk or&#xD;
      particularly high local recurrence. The induction chemotherapy is a first-line treatment of&#xD;
      cancer in which the patient receives doses of chemotherapy allowing to obtain a significant&#xD;
      reduction in tumor size, and thus to avoid the surgery and to treat the tumor then by&#xD;
      radiotherapy alone or combine by certain drugs. The standard treatment of induction&#xD;
      chemotherapy currently used for the carcinoma of aerodigestive tract is TPF compose of 3&#xD;
      drugs: the docetaxel (or Taxotere®, T), the cisplatin (P) and the 5-fluorouracil (or 5FU, F).&#xD;
      Despite of the relative efficacy of this treatment, which provides a survival benefit, it is&#xD;
      necessary to find a combination of induction to be more effective and less toxic. That is why&#xD;
      this study intended to check if a new combination called TPA in which the fluorouracil (F) is&#xD;
      replaced by the afatinib (A), will be more beneficial. The afatinib is a powerful and&#xD;
      irreversible inhibitor of the EGFR (human Epidermal Growth Factor Receptor type 1), HER2 and&#xD;
      HER 4. The EGFR is associated with a pejorative prognosis and resistance to the treatments&#xD;
      through its role in the proliferation (multiplication of tumoral cells), the cell survival&#xD;
      and replication and angiogenesis (process of growth of new blood-vessels, vital in the growth&#xD;
      of the malignant tumors). Afatinib has proved effective in patients in with local recurrence&#xD;
      or metastatic squamous cell carcinoma of the head and neck after first line cisplatin based&#xD;
      and tolerance is correct.&#xD;
&#xD;
      The rational of this study is based on the following elements:&#xD;
&#xD;
        -  Cisplatin and docetaxel on the one hand and the afatinib on the other hand have proved&#xD;
           effectiveness in head and neck cancers. The tolerance of their association is not known.&#xD;
&#xD;
        -  In addition, several broad randomized trials have shown that it is possible to improve&#xD;
           the effectiveness of induction chemotherapy in locally advanced head and neck carcinoma&#xD;
           by the addition of Taxotere® to the cisplatin-5FU.&#xD;
&#xD;
        -  Independently, it has been shown in carcinoma of the upper aerodigestive tract with&#xD;
           recurrence or metastatic, that an anti-EGFR targeted therapy by cetuximab could improve&#xD;
           the effectiveness of chemotherapy with cisplatin-5FU More recently, Taxotere® and&#xD;
           Cisplatin + Cetuximab (or Erbitux®) combination for the treatment of head and neck&#xD;
           squamous cell carcinoma has been tested in a broad study of phase II showing the good&#xD;
           feasibility of this combination and a particularly high rate of tumoral response.&#xD;
&#xD;
        -  Finally a comparative study of cetuximab versus afatinib showed an advantage in terms of&#xD;
           tumoral response in support of afatinib.&#xD;
&#xD;
      From all these observations, the investigators can hypothesize that the addition of afatinib&#xD;
      to the docetaxel and the cisplatin could be an induction treatment for locally advanced&#xD;
      carcinoma both innovating and promising. Indeed, this regimen appears optimized in terms of&#xD;
      efficiency, incorporating both the combination of the most active cytotoxic agents, Taxotere®&#xD;
      and the cisplatin, but also potentially more effective than Erbitux®.&#xD;
&#xD;
      The purpose of the study is to determine the Maximum Tolerated Dose (MTD) of afatinib&#xD;
      administrated in combination with docetaxel (Taxotere®) and cisplatin in induction&#xD;
      chemotherapy of locally advanced head and neck carcinoma in order to move to a phase II,&#xD;
      allowing the comparison with standard induction chemotherapy TPF.&#xD;
&#xD;
      It is a multicentric, national, opened, not-randomized phase Ib. Three doses of the afatinib&#xD;
      (20, 30 and 40 Mg per day) will be studied in combination with the fixed standard doses of&#xD;
      the docetaxel and the cisplatin. For each dose level, beginning with smallest (20 Mg per day&#xD;
      of afatinib), 3 to 6 patients will be treated at maximum, i.e. 3 cycles of three weeks&#xD;
      treatment each one (9 weeks on the whole). The next dose level will be studied only if the&#xD;
      previous dose is well tolerated for the period of the first 4 weeks observation of the&#xD;
      treatment (1st cycle and first week of the 2nd cycle). Once the MTD is determine, four&#xD;
      additional patients will be treated with this dose. A maximum of 22 patients should be&#xD;
      included in this study. The total duration of the study is estimated at 18 months. In case of&#xD;
      major safety problems, the study may be stopped earlier. In short, the preclinical data,&#xD;
      pharmacological and clinical on afatinib indicate that the benefit-risk ratio can be regarded&#xD;
      as positive and that the association of afatinib with cisplatin and docetaxel could be&#xD;
      effective in patients with head and neck squamous cell carcinoma potentially resulting in an&#xD;
      extension of time to progression.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 6, 2014</start_date>
  <completion_date type="Actual">September 15, 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <phase>Phase 1</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>Maximum Tolerated Dose (MTD)</measure>
    <time_frame>During the first 4 weeks of treatment for each patient of the bearing.</time_frame>
    <description>The main objective is to determine the Maximum Tolerated Dose (MTD) of afatinib in combination with docetaxel and cisplatin chemotherapy TPA induction in locally advanced head and neck carcinomas in order to move a phase II for comparison with induction chemotherapy &quot;of reference &quot;TPF (Taxotere, cisplatin and 5-fluorouracil).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tolerance</measure>
    <time_frame>12 weeks</time_frame>
    <description>Tolerance: Toxicity will be evaluated by NCI CTCAE V4.03. scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy</measure>
    <time_frame>12 weeks</time_frame>
    <description>Efficacy: Objective tumor response will be evaluated through RECIST V1.1</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Correlation between nutritional status and toxicity</measure>
    <time_frame>12 weeks</time_frame>
    <description>Objective is to correlate the values of body fat / lean mass determined by CT-scan to the nutritional status of the patients and toxicities.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>HNSCC</condition>
  <arm_group>
    <arm_group_label>Induction chemotherapy TPA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 Cycles of induction chemotherapy TPA : (Taxotere, Cisplatin, Afatinib)&#xD;
1 cycle = 3 weeks, three cycles of treatment in total (or 9 weeks)&#xD;
Docetaxel 75 mg / m2 at D1 Cisplatin 75 mg / m 2 at D1 Afatinib: x mg / day D2 to D21 by level: (Level 1: 20 mg / day; Level 2: 30 mg / day; Level 3: 40 mg / day)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Taxotere, Cisplatin, Afatinib</intervention_name>
    <arm_group_label>Induction chemotherapy TPA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years and ≤70 years&#xD;
&#xD;
          -  Patient in first line treatment of Locally Advanced HNSCC, histologically proven&#xD;
             non-metastatic&#xD;
&#xD;
          -  At least one measurable lesion (RECIST)&#xD;
&#xD;
          -  Eligible patient for standard induction chemotherapy in the opinion of the&#xD;
             investigator; PS ECOG &lt; 2&#xD;
&#xD;
        Adequacy functioning of organs, including:&#xD;
&#xD;
          -  Left ventricular function with ejection fraction at rest &gt; 50% or as normal&#xD;
             institutional values Haematological function&#xD;
&#xD;
          -  Absolute neutrophil count (ANC) &gt;1,500/mm3 Special cases: ANC&gt; 1,000/mm3 in the&#xD;
             opinion of the investigator and discussion with the sponsor; Platelets ≥ 75,000/mm3;&#xD;
             Hemoglobin&gt; 10g/dl&#xD;
&#xD;
        Liver function:&#xD;
&#xD;
        •Total bilirubin ≤ 1.5 x ULN; patients with Gilbert's syndrome must have a total bilirubin&#xD;
        &lt;4 x ULN; SGOT and SGPT ≤ 3 x ULN or SGOT and SGPT ≤ 5 x ULN in case liver abnormalities;&#xD;
        Alkaline phosphatase &lt;2.5 x ULN&#xD;
&#xD;
        Kidney function:&#xD;
&#xD;
        •Serum creatinine &lt;110 umol/L or creatinine clearance &gt; 45 ml/min (Cockcroft method)&#xD;
&#xD;
        General:&#xD;
&#xD;
          -  Men and women of childbearing potential must agree to use a reliable contraception&#xD;
             throughout treatment and at least 6 months after the end of treatment. Women in&#xD;
             peri-menopause should be least 24 months of amenorrhea.&#xD;
&#xD;
          -  Ability to take oral medication in the opinion of the investigator; Patient affiliated&#xD;
             to a social security system; signed informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        •Previous treatment with chemotherapy, radiation therapy or targeted therapy for head and&#xD;
        neck cancer; uncontrolled Respiratory, cardiac, hepatic or renal diseases.&#xD;
&#xD;
        Significant cardiovascular disease like:&#xD;
&#xD;
          -  Cardiovascular Abnormalities considered clinically important as congestive heart&#xD;
             failure NYHA stage ≥ III, unstable angina or myocardial infarction within the past 6&#xD;
             months, or arrhythmia low controlled, uncontrolled hypertension by treatment (systolic&#xD;
             BP ≥ 160 mmHg and/or diastolic BP≥ 90 mmHg).&#xD;
&#xD;
          -  Impairment of left ventricular function with an ejection fraction ≤ 50%; Stroke within&#xD;
             6 months prior to inclusion.&#xD;
&#xD;
          -  Severe thromboembolic history within 6 months prior to inclusion.&#xD;
&#xD;
          -  Lengthening of the corrected QT interval with QTc&gt; 480 msec according to the formula&#xD;
             Bazet; Bradycardia; Electrolyte disturbances&#xD;
&#xD;
        Respiratory disease of type:&#xD;
&#xD;
        •interstitial lung disease; Pulmonary fibrosis&#xD;
&#xD;
        Viral disease of type:&#xD;
&#xD;
        •Active infection or hepatic B virus or hepatitis C known carrier of HIV.&#xD;
&#xD;
        Recent digestive disorder with diarrhea such as:&#xD;
&#xD;
          -  Any history or presence of gastrointestinal disorders with uncontrolled diarrhea as a&#xD;
             major symptom that may affect the absorption of drug tested in the opinion of the&#xD;
             investigator (eg disease Crohn's disease, diarrhea CTCAE grade ≥ 2)&#xD;
&#xD;
          -  Any past or present condition that would compromise the patient's ability to comply&#xD;
             with the study or which would interfere with the evaluation of the effectiveness and&#xD;
             the safety of the study.&#xD;
&#xD;
          -  Other severe disease or condition associated with non-oncological origin likely to be&#xD;
             incompatible with the protocol in the judgment of the investigator.&#xD;
&#xD;
          -  Patient already included in another clinical trial with an experimental molecule;&#xD;
             Persons deprived of liberty or under guardianship or as backup justice.&#xD;
&#xD;
          -  Patient requiring prohibited concomitant treatments with study.&#xD;
&#xD;
          -  Any cons-indication to treatment with Taxotere or Afatinib or cisplatin.&#xD;
&#xD;
          -  Known hypersensitivity to Afatinib or excipients the study drugs; Major surgery within&#xD;
             4 weeks before taking treatment; Use of products in a clinical study during the 4&#xD;
             weeks preceding inclusion.&#xD;
&#xD;
        Radiation therapy within 4 weeks before inclusion.&#xD;
&#xD;
        •Presence and / or history (in the past 3 years) cancer except Basal cell skin cancer,&#xD;
        cervical carcinoma in situ and prostate cancer in situ; Pregnant or during breastfeeding.&#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>Didier CUPISSOL, MD</last_name>
    <role>Study Chair</role>
    <affiliation>GORTEC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ICM Val d'Aurelle, Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34298</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>http://www.gortec.fr/</url>
    <description>Related Info</description>
  </link>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</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 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Docetaxel</mesh_term>
    <mesh_term>Afatinib</mesh_term>
  </intervention_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/NCT02216617
org study id: GORTEC 2013-01
secondary id: 2013-002876-42
nct id: NCT02216617
lead sponsor: 
has dmc: Yes
The purpose of the study is to determine the maximum tolerated dose (MTD) of afatinib
      administrated in combination with docetaxel (Taxotere®) and cisplatin in induction
      chemotherapy of locally advanced head and neck carcinoma in order to move to a phase II,
      allowing the comparison with standard induction chemotherapy TPF.

      It is a multicentric, national, opened, not-randomized phase Ib. Three doses of afatinib (20,
      30 and 40 Mg per day) will be studied in combination with the fixed standard doses of
      docetaxel and cisplatin. For each dose level, beginning with smallest (20 Mg per day of
      afatinib), 3 to 6 patients will be treated at maximum, i.e. 3 cycles of three weeks treatment
      each one (9 weeks on the whole). The next dose level will be studied only if the previous
      dose is well tolerated for the period of the first 4 weeks observation of the treatment (1st
      cycle more first week of the 2nd cycle). Once the MTD is determined, four additional patients
      will be treated with this dose. A maximum of 22 patients should be included in this study.
      The total duration of the study is estimated at 18 months. In case of major safety problems,
      the study may be stopped earlier. In short, the preclinical data, pharmacological and
      clinical on afatinib indicate that the benefit-risk ratio can be regarded as positive and
      that the association of afatinib with cisplatin and docetaxel could be effective in patients
      with head and neck squamous cell carcinoma potentially resulting in an extension of time to
      progression.
Cancers of the upper aerodigestive tract correspond in the Western countries about 5% of
      cancers. They are treated by surgery, radiotherapy, and chemotherapy. Although progress in
      radio chemotherapy have reduced mortality and increase the rates of organ preservation in
      patients with locally advanced head and neck cancers, they have metastatic risk or
      particularly high local recurrence. The induction chemotherapy is a first-line treatment of
      cancer in which the patient receives doses of chemotherapy allowing to obtain a significant
      reduction in tumor size, and thus to avoid the surgery and to treat the tumor then by
      radiotherapy alone or combine by certain drugs. The standard treatment of induction
      chemotherapy currently used for the carcinoma of aerodigestive tract is TPF compose of 3
      drugs: the docetaxel (or Taxotere®, T), the cisplatin (P) and the 5-fluorouracil (or 5FU, F).
      Despite of the relative efficacy of this treatment, which provides a survival benefit, it is
      necessary to find a combination of induction to be more effective and less toxic. That is why
      this study intended to check if a new combination called TPA in which the fluorouracil (F) is
      replaced by the afatinib (A), will be more beneficial. The afatinib is a powerful and
      irreversible inhibitor of the EGFR (human Epidermal Growth Factor Receptor type 1), HER2 and
      HER 4. The EGFR is associated with a pejorative prognosis and resistance to the treatments
      through its role in the proliferation (multiplication of tumoral cells), the cell survival
      and replication and angiogenesis (process of growth of new blood-vessels, vital in the growth
      of the malignant tumors). Afatinib has proved effective in patients in with local recurrence
      or metastatic squamous cell carcinoma of the head and neck after first line cisplatin based
      and tolerance is correct.

      The rational of this study is based on the following elements:

        -  Cisplatin and docetaxel on the one hand and the afatinib on the other hand have proved
           effectiveness in head and neck cancers. The tolerance of their association is not known.

        -  In addition, several broad randomized trials have shown that it is possible to improve
           the effectiveness of induction chemotherapy in locally advanced head and neck carcinoma
           by the addition of Taxotere® to the cisplatin-5FU.

        -  Independently, it has been shown in carcinoma of the upper aerodigestive tract with
           recurrence or metastatic, that an anti-EGFR targeted therapy by cetuximab could improve
           the effectiveness of chemotherapy with cisplatin-5FU More recently, Taxotere® and
           Cisplatin + Cetuximab (or Erbitux®) combination for the treatment of head and neck
           squamous cell carcinoma has been tested in a broad study of phase II showing the good
           feasibility of this combination and a particularly high rate of tumoral response.

        -  Finally a comparative study of cetuximab versus afatinib showed an advantage in terms of
           tumoral response in support of afatinib.

      From all these observations, the investigators can hypothesize that the addition of afatinib
      to the docetaxel and the cisplatin could be an induction treatment for locally advanced
      carcinoma both innovating and promising. Indeed, this regimen appears optimized in terms of
      efficiency, incorporating both the combination of the most active cytotoxic agents, Taxotere®
      and the cisplatin, but also potentially more effective than Erbitux®.

      The purpose of the study is to determine the Maximum Tolerated Dose (MTD) of afatinib
      administrated in combination with docetaxel (Taxotere®) and cisplatin in induction
      chemotherapy of locally advanced head and neck carcinoma in order to move to a phase II,
      allowing the comparison with standard induction chemotherapy TPF.

      It is a multicentric, national, opened, not-randomized phase Ib. Three doses of the afatinib
      (20, 30 and 40 Mg per day) will be studied in combination with the fixed standard doses of
      the docetaxel and the cisplatin. For each dose level, beginning with smallest (20 Mg per day
      of afatinib), 3 to 6 patients will be treated at maximum, i.e. 3 cycles of three weeks
      treatment each one (9 weeks on the whole). The next dose level will be studied only if the
      previous dose is well tolerated for the period of the first 4 weeks observation of the
      treatment (1st cycle and first week of the 2nd cycle). Once the MTD is determine, four
      additional patients will be treated with this dose. A maximum of 22 patients should be
      included in this study. The total duration of the study is estimated at 18 months. In case of
      major safety problems, the study may be stopped earlier. In short, the preclinical data,
      pharmacological and clinical on afatinib indicate that the benefit-risk ratio can be regarded
      as positive and that the association of afatinib with cisplatin and docetaxel could be
      effective in patients with head and neck squamous cell carcinoma potentially resulting in an
      extension of time to progression.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum Tolerated Dose (MTD)
time frame: During the first 4 weeks of treatment for each patient of the bearing.
description: The main objective is to determine the Maximum Tolerated Dose (MTD) of afatinib in combination with docetaxel and cisplatin chemotherapy TPA induction in locally advanced head and neck carcinomas in order to move a phase II for comparison with induction chemotherapy "of reference "TPF (Taxotere, cisplatin and 5-fluorouracil).
measure: Tolerance
time frame: 12 weeks
description: Tolerance: Toxicity will be evaluated by NCI CTCAE V4.03. scale
measure: Efficacy
time frame: 12 weeks
description: Efficacy: Objective tumor response will be evaluated through RECIST V1.1
measure: Correlation between nutritional status and toxicity
time frame: 12 weeks
description: Objective is to correlate the values of body fat / lean mass determined by CT-scan to the nutritional status of the patients and toxicities.
arm group label: Induction chemotherapy TPA
arm group type: Experimental
description: 3 Cycles of induction chemotherapy TPA : (Taxotere, Cisplatin, Afatinib)
1 cycle = 3 weeks, three cycles of treatment in total (or 9 weeks)
Docetaxel 75 mg / m2 at D1 Cisplatin 75 mg / m 2 at D1 Afatinib: x mg / day D2 to D21 by level: (Level 1: 20 mg / day; Level 2: 30 mg / day; Level 3: 40 mg / day)
intervention type: Drug
intervention name: Taxotere, Cisplatin, Afatinib
arm group label: Induction chemotherapy TPA
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Didier CUPISSOL, MD
role: Study Chair
affiliation: GORTEC
facility: 
country: France
url: http://www.gortec.fr/
description: Related Info
responsible party type: Sponsor
mesh term: Docetaxel
mesh term: Afatinib