<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/NCT02998385</url>
  </required_header>
  <id_info>
    <org_study_id>GORTEC 2016-02</org_study_id>
    <nct_id>NCT02998385</nct_id>
  </id_info>
  <brief_title>Chemo-radiotherapy Versus Radiotherapy in the Treatment of Salivary Glands and Nasal Tumors (IMRT or Protontherapy)</brief_title>
  <acronym>SANTAL</acronym>
  <official_title>A Phase III Randomized Study of Chemo-radiotherapy Versus Radiotherapy Alone in the Adjuvant Treatment of Salivary Glands and Nasal Tumors (IMRT or Protontherapy)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Groupe Oncologie Radiotherapie Tete et Cou</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Groupe Oncologie Radiotherapie Tete et Cou</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>
      A phase III, multicenter, randomized, open-label, french study comparing:&#xD;
&#xD;
        -  Arm A : Radiotherapy alone (66 to 70 Gy; 5 fractions/week; 1fraction/day; 2 Gy/fraction)&#xD;
           (IMRT or protontherapy)&#xD;
&#xD;
        -  Arm B: Radiotherapy (66 to 70 Gy; 5 fractions/week; 1fraction/day; 2 Gy/fraction; IMRT&#xD;
           or protontherapy) + concomitant cisplatin 100 mg/m2 IV on day 1 - J22 - 43 (3 cycles)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Carcinomas of the sinuses and the salivary glands are rare. They are heterogeneous in terms&#xD;
      of anatomical sites and histology subtypes. For this reason and in the absence of prospective&#xD;
      study, their treatment is still largely extrapolated from data of frequent carcinomas of the&#xD;
      upper digestive tract. These tumors are most often diagnosed lately. Their treatment is based&#xD;
      on a multimodal management of care, with a central place for the surgery and radiotherapy&#xD;
      (Proof level Grade C). Despite the advances in surgical techniques, and the addition of&#xD;
      radiation therapy, the 5-year overall survival probability does not exceed 65% mainly due to&#xD;
      a loco regional development.&#xD;
&#xD;
      In this context, a chemotherapy administered concomitantly to radiotherapy, could increase&#xD;
      the efficacy of the locoregional treatment by a radiosensibilization process and regardless&#xD;
      of the histology. This point is regularly discussed in multidisciplinary concertation&#xD;
      meeting, including bi-monthly national REFCOR meeting (network of French Expertise on rare&#xD;
      Cancers of the head and neck). At present, the lack of data brings even to discuss the&#xD;
      addition of cisplatin to exclusive irradiation of unresectable or not operable tumors.&#xD;
&#xD;
      No randomized study has been published in this context. The first comparative prospective&#xD;
      study addressing the addition of weekly cisplatin to the adjuvant irradiation of salivary, is&#xD;
      a phase II randomized study (Radiation Therapy Oncology Group - RTOG 1008) currently&#xD;
      enrolling patients in the United States of America.&#xD;
&#xD;
      The Sponsor propose to conduct a phase III randomized study evaluating the impact of the&#xD;
      addition of cisplatin to a treatment by radiotherapy in adjuvant setting (≥ 65 Gy) in case of&#xD;
      a high risk of recurrence: case of radioresistant histologies (e.g. cystic fibrosis adenoids&#xD;
      carcinomas), or case of unfavourable histo-prognostic criteria (incomplete resection,&#xD;
      presence of emboli, etc.) in this population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 20, 2017</start_date>
  <completion_date type="Anticipated">March 2030</completion_date>
  <primary_completion_date type="Anticipated">February 2030</primary_completion_date>
  <phase>Phase 3</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>From date of randomization to date of disease progression or death, which occur first, assessed during 62 months</time_frame>
    <description>Compare progression-free survival between the 2 treatment arms: radiation therapy alone versus radiochimiotherapy in adjuvant patients treatment operated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>From date of randomization to date of death, assessed during 62 months</time_frame>
    <description>Compare the 2 arms of treatment in operated patients in terms of overall survival</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Assessment of quality of Life: QLQC30 overall score</measure>
    <time_frame>From date of randomization to end of study or death or progression (the first occurred), assessed during 62 months</time_frame>
    <description>Compare quality of life (QLQC30 overall score) between arms</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">260</enrollment>
  <condition>HNSCC</condition>
  <arm_group>
    <arm_group_label>Radiotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Arm A&#xD;
Radiation therapy: 66 to 70 Gy in fractions of 2 Gy, 1 fraction/day, 5 fractions per week.&#xD;
Radiation therapy will be conducted by conformational intensity modulation radiotherapy (IMRT) or protontherapy. Irradiation by 3D conformational radiotherapy can be discussed on a case by case with the Intergroup Coordinator GORTEC.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Radiotherapy + concomitant cisplatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm B Concomitant systemic treatment with cisplatin + radiotherapy&#xD;
According to standard protocol of concomitant cisplatin 100 mg/m2 IV on day 1 - J22 - 43 (3 maximum cycles).&#xD;
Radiation therapy: 66 to 70 Gy in fractions of 2 Gy, 1 fraction/day, 5 fractions per week.&#xD;
Radiation therapy will be conducted by conformational intensity modulation radiotherapy (IMRT) or protontherapy. Irradiation by 3D conformational radiotherapy can be discussed on a case by case with the Intergroup Coordinator GORTEC</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>intravenous, concomitant to irradiation</description>
    <arm_group_label>Radiotherapy + concomitant cisplatin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>radiotherapy</intervention_name>
    <description>66 à 70 Gy per fractions of 2 Gy, 1 fraction/day, 5 fractions/week</description>
    <arm_group_label>Radiotherapy</arm_group_label>
    <arm_group_label>Radiotherapy + concomitant cisplatin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Resected tumors of the sinus or the salivary glands T3-4, N1-3 or T1-2 N0, with overgrown&#xD;
        banks or positive margins (&lt; 5 mm)&#xD;
&#xD;
        or&#xD;
&#xD;
        Unresectable or not operable tumors of salivary glands or sinuses&#xD;
&#xD;
          -  Carcinomas of the main salivary glands (parotid, submandibular or sublingual glands)&#xD;
             and accessories or Malignant sinus tumors with any histological type except melanoma,&#xD;
             lymphoma, mesenchymal tumor (sarcoma type), squamous cell carcinoma and nasopharyngeal&#xD;
             carcinoma type 1, 2, 3.&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Performance status 0 -2 (WHO criteria)&#xD;
&#xD;
          -  For patients ≥ 70 years, the score to the G8 questionnaire must be &gt; 14 with no fall&#xD;
             in the previous 12 months or with a geriatric assessment consistent with the&#xD;
             administration of chemotherapy&#xD;
&#xD;
          -  Estimated life expectancy greater than or equal to 6 months&#xD;
&#xD;
          -  Neutrophils &gt; 1.5 x 109/l, platelets &gt; 100 x 109/l, hemoglobin ≥ 9.5 g/dl, bilirubin ≤&#xD;
             3 x upper normal value (ULN), AST/ALT &lt; 5 ULN, PAL &lt; 3 ULN&#xD;
&#xD;
          -  Creatinin Clearance ≥ 60 mL/min (Cockroft formula)&#xD;
&#xD;
          -  Adequate cardiac function according to the investigator, compatible with the&#xD;
             administration of cisplatin 100 mg/m²&#xD;
&#xD;
          -  Affiliation to a social insurance or beneficiary of such a regimen&#xD;
&#xD;
          -  Patient having given his written consent signed before any study specific procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of radiotherapy in the ENT region and/or neoadjuvant chemotherapy for the&#xD;
             pathology concerned&#xD;
&#xD;
          -  Synchronous metastases&#xD;
&#xD;
          -  Contraindications for administration of cisplatin or carboplatin&#xD;
&#xD;
          -  Allergy to cisplatin and/or its excipients&#xD;
&#xD;
          -  Vaccination against yellow fever, recent or planned&#xD;
&#xD;
          -  Administration of phenytoin with prophylactic purpose&#xD;
&#xD;
          -  Other cancer, except for cancer in situ of the cervix, skin Carcinoma (except&#xD;
             melanoma) or cancer controlled for more than 5 years&#xD;
&#xD;
          -  Pregnant, breastfeeding or without birth control woman. Woman having the ability to&#xD;
             procreate should have (serum or urinary) negative pregnancy test within 14 days prior&#xD;
             to study treatment decision-making. (Men or women) patients should use a reliable&#xD;
             contraceptive method throughout the treatment and at least 6 months after the end of&#xD;
             chemotherapy.&#xD;
&#xD;
          -  Persons deprived of liberty under supervision or under curatorship, or unable to&#xD;
             adhere to medical follow-up of the study for geographical, social or psychological&#xD;
             reasons.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>François Régis FERRAND, MD</last_name>
    <phone>+33 1 43 98 50 78</phone>
    <email>francoisregisferrand@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Juliette THARIAT, Prof</last_name>
    <phone>+33 06 45 53 98 01</phone>
    <email>j.thariat@baclesse.unicancer.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hôpital Bégin</name>
      <address>
        <city>Saint-Mandé</city>
        <zip>94</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>François Régis FERRAND, MD</last_name>
      <email>francoisregisferrand@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Nicolas MEERT, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>March 10, 2022</last_update_submitted>
  <last_update_submitted_qc>March 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>salivary glands</keyword>
  <keyword>sinus carcinoma</keyword>
  <keyword>radiochemotherapy concomitant</keyword>
  <keyword>cisplatin</keyword>
  <keyword>protontherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nose Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cisplatin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02998385
org study id: GORTEC 2016-02
nct id: NCT02998385
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A phase III, multicenter, randomized, open-label, french study comparing:

        -  Arm A : Radiotherapy alone (66 to 70 Gy; 5 fractions/week; 1fraction/day; 2 Gy/fraction)
           (IMRT or protontherapy)

        -  Arm B: Radiotherapy (66 to 70 Gy; 5 fractions/week; 1fraction/day; 2 Gy/fraction; IMRT
           or protontherapy) + concomitant cisplatin 100 mg/m2 IV on day 1 - J22 - 43 (3 cycles)
Carcinomas of the sinuses and the salivary glands are rare. They are heterogeneous in terms
      of anatomical sites and histology subtypes. For this reason and in the absence of prospective
      study, their treatment is still largely extrapolated from data of frequent carcinomas of the
      upper digestive tract. These tumors are most often diagnosed lately. Their treatment is based
      on a multimodal management of care, with a central place for the surgery and radiotherapy
      (Proof level Grade C). Despite the advances in surgical techniques, and the addition of
      radiation therapy, the 5-year overall survival probability does not exceed 65% mainly due to
      a loco regional development.

      In this context, a chemotherapy administered concomitantly to radiotherapy, could increase
      the efficacy of the locoregional treatment by a radiosensibilization process and regardless
      of the histology. This point is regularly discussed in multidisciplinary concertation
      meeting, including bi-monthly national REFCOR meeting (network of French Expertise on rare
      Cancers of the head and neck). At present, the lack of data brings even to discuss the
      addition of cisplatin to exclusive irradiation of unresectable or not operable tumors.

      No randomized study has been published in this context. The first comparative prospective
      study addressing the addition of weekly cisplatin to the adjuvant irradiation of salivary, is
      a phase II randomized study (Radiation Therapy Oncology Group - RTOG 1008) currently
      enrolling patients in the United States of America.

      The Sponsor propose to conduct a phase III randomized study evaluating the impact of the
      addition of cisplatin to a treatment by radiotherapy in adjuvant setting (≥ 65 Gy) in case of
      a high risk of recurrence: case of radioresistant histologies (e.g. cystic fibrosis adenoids
      carcinomas), or case of unfavourable histo-prognostic criteria (incomplete resection,
      presence of emboli, etc.) in this population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-free survival
time frame: From date of randomization to date of disease progression or death, which occur first, assessed during 62 months
description: Compare progression-free survival between the 2 treatment arms: radiation therapy alone versus radiochimiotherapy in adjuvant patients treatment operated.
measure: Overall Survival
time frame: From date of randomization to date of death, assessed during 62 months
description: Compare the 2 arms of treatment in operated patients in terms of overall survival
measure: Assessment of quality of Life: QLQC30 overall score
time frame: From date of randomization to end of study or death or progression (the first occurred), assessed during 62 months
description: Compare quality of life (QLQC30 overall score) between arms
arm group label: Radiotherapy
arm group type: Active Comparator
description: Arm A
Radiation therapy: 66 to 70 Gy in fractions of 2 Gy, 1 fraction/day, 5 fractions per week.
Radiation therapy will be conducted by conformational intensity modulation radiotherapy (IMRT) or protontherapy. Irradiation by 3D conformational radiotherapy can be discussed on a case by case with the Intergroup Coordinator GORTEC.
arm group label: Radiotherapy + concomitant cisplatin
arm group type: Experimental
description: Arm B Concomitant systemic treatment with cisplatin + radiotherapy
According to standard protocol of concomitant cisplatin 100 mg/m2 IV on day 1 - J22 - 43 (3 maximum cycles).
Radiation therapy: 66 to 70 Gy in fractions of 2 Gy, 1 fraction/day, 5 fractions per week.
Radiation therapy will be conducted by conformational intensity modulation radiotherapy (IMRT) or protontherapy. Irradiation by 3D conformational radiotherapy can be discussed on a case by case with the Intergroup Coordinator GORTEC
intervention type: Drug
intervention name: Cisplatin
description: intravenous, concomitant to irradiation
arm group label: Radiotherapy + concomitant cisplatin
intervention type: Radiation
intervention name: radiotherapy
description: 66 à 70 Gy per fractions of 2 Gy, 1 fraction/day, 5 fractions/week
arm group label: Radiotherapy
arm group label: Radiotherapy + concomitant cisplatin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: François Régis FERRAND, MD
phone: +33 1 43 98 50 78
email: francoisregisferrand@gmail.com
last name: Juliette THARIAT, Prof
phone: +33 06 45 53 98 01
email: j.thariat@baclesse.unicancer.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Nose Neoplasms
mesh term: Cisplatin
sharing ipd: No