<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/NCT02985255</url>
  </required_header>
  <id_info>
    <org_study_id>HCG/SX/001/2016</org_study_id>
    <nct_id>NCT02985255</nct_id>
  </id_info>
  <brief_title>Role of Neo-adjuvant Chemotherapy in Tongue Preservation in Locally Advanced Squamous Cell Carcinoma of Oral Tongue</brief_title>
  <official_title>Role of Neo-adjuvant Chemotherapy in Organ Preservation in Locally Advanced Squamous Cell Carcinoma of Oral Tongue</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HealthCare Global Enterprise Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HealthCare Global Enterprise Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients enrolled for the study, who are eligible for NACT, will undergo a pre-treatment&#xD;
      workup comprising of Evaluation Under Anesthesia (EUA) for tumor Mapping and tissue biopsy&#xD;
      along with a PET-CT scan. Subsequently, they would undergo 3 cycles of NACT (weekly thrice)&#xD;
      with DCF. They would be reassessed with PET-CT and EUA +/- biopsy after the end of the third&#xD;
      cycle. Those who are achieving CR would undergo adjuvant CTRT. Subjects who have a PR in the&#xD;
      PET-CT scan will be re-classified based on the biopsy report. If they remain in the PR group&#xD;
      they will undergo surgery but if the biopsy in is negative for malignancy, they will undergo&#xD;
      adjuvant CTRT. Those subjects with SD or PD would undergo surgery. Subsequently, further&#xD;
      radiation and/ or chemotherapy will be decided based on the final histopathology (of the&#xD;
      surgical specimen) reports.&#xD;
&#xD;
      PET-CT and EUA +/- HPE analyses would be repeated on follow-up after 3 months of treatment&#xD;
      completion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients enrolled for the study, who are eligible for Neoadjuvant chemotherapy, will undergo&#xD;
      a pre-treatment workup comprising of Evaluation Under Anesthesia (EUA) for tumor Mapping and&#xD;
      tissue biopsy along with a PET-CT scan. Subsequently, they would undergo 3 cycles of&#xD;
      Neoadjuvant chemotherapy (weekly thrice) with injection Docetaxel, Cisplatin, and 5-FU. They&#xD;
      would be reassessed with PET-CT and EUA +/- biopsy after the end of the third cycle. Those&#xD;
      who are achieving a Complete Response (CR) would undergo adjuvant chemo-radiotherapy.&#xD;
      Subjects who have a partial response (PR) in the PET-CT scan will be re-classified based on&#xD;
      the biopsy report. If they remain in the PR group they will undergo surgery. If the biopsy in&#xD;
      these patients is negative for malignancy, they will undergo adjuvant chemoradiotherapy.&#xD;
      Those subjects with stable disease (SD) or progressive disease (PD) would undergo surgery.&#xD;
      Subsequently, further radiation and/ or chemotherapy will be decided based on the final&#xD;
      histopathology (of the surgical specimen) reports.&#xD;
&#xD;
      PET-CT and EUA +/- HPE analyses would be repeated on follow-up after 3 months of treatment&#xD;
      completion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2016</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">June 2017</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>Tongue Preservation Rate</measure>
    <time_frame>At Response evaluation post 3rd CT Cycle (approximately 7 months post recruitment)</time_frame>
    <description>A ratio of the number of study subjects who have achieved a complete response and do not require surgery, after 3 cycles of NaCT to the total number of subjects recruited to the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>2 years post treatment completion</time_frame>
    <description>Overall Survival Rate (Date of diagnosis to date of death or last follow-up) in different sub-cohorts of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>2 years post treatment completion</time_frame>
    <description>Progression Free Survival Rate (Primary treatment end date to date of progression or last follow-up) in difference sub-cohorts of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity and Specificity of PET-CT</measure>
    <time_frame>At Baseline and after 12-15 weeks (post 3 cycles of NaCT (Typically 3 weeks))</time_frame>
    <description>Ability of PETCT (along with HPE and EUA) to detect response rates in study subjects undergoing NACT for Ca Tongue</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Tongue Neoplasms</condition>
  <condition>Squamous Cell Carcinoma</condition>
  <condition>Anterior Tongue Squamous Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>Neoadjuvant Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study Subjects, eligible for NACT would undergo a pretreatment workup with Evaluation Under Anesthesia for tumor Mapping and tissue biopsy along with a PET-CT scan. They would undergo 3 cycles of NACT (weekly thrice) with injection Docetaxel, Cisplatin and 5-FU after which reassessment with PET-CT and EUA +/- biopsy would be done. Those achieving CR would undergo adjuvant CTRT while subjects with PR in PET-CT scan will be reclassified based on the biopsy report. If biopsy is negative for malignancy, they will undergo adjuvant CTRT but would undergo surgery if in the PR group. Subjects with SD or PD would undergo surgery. PET-CT and EUA +/- HPE analyses would be repeated on follow-up after 3 months of treatment completion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Docetaxel</intervention_name>
    <description>Neoadjuvant Arm</description>
    <arm_group_label>Neoadjuvant Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>Neoadjuvant Arm</description>
    <arm_group_label>Neoadjuvant Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>5FU</intervention_name>
    <description>Neoadjuvant Arm</description>
    <arm_group_label>Neoadjuvant Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiotherapy</intervention_name>
    <description>Neoadjuvant Arm</description>
    <arm_group_label>Neoadjuvant Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Glossectomy</intervention_name>
    <description>Neoadjuvant Arm</description>
    <arm_group_label>Neoadjuvant Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of newly diagnosed squamous cell carcinoma (well/ moderately/ poorly&#xD;
             differentiated) of oral tongue (anterior two third) presenting to Health Care Global&#xD;
             Enterprises Ltd between January 2016 to March 2017 will be included in the study.&#xD;
&#xD;
          -  Stage III and stage IV (T3, 4 N0-3, M 0) and selected cases of T2 with advanced nodal&#xD;
             status will also be included in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients having recurrence/ residual disease of oral tongue.&#xD;
&#xD;
          -  Patients who have received alternative treatments before being evaluated for NACT&#xD;
&#xD;
          -  Patient who are not fit for NACT&#xD;
&#xD;
          -  Patient not able to give consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vishal US Rao, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dept of Head &amp; Neck Surgery, HealthCare Global Enterprises Ltd.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Vishal US Rao, MS</last_name>
    <phone>00919739774949</phone>
    <email>drvishalrao@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sataksi Chatterjee, MS</last_name>
    <phone>00918971966903</phone>
    <email>sataksis2007@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>HealthCare Global Enterprises Ltd</name>
      <address>
        <city>Bangalore</city>
        <state>Karnataka</state>
        <zip>560027</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vishal US Rao, MS</last_name>
      <phone>00919739774949</phone>
      <email>drvishalrao@yahoo.com</email>
    </contact>
    <contact_backup>
      <last_name>Sataksi Chatterjee, MS</last_name>
      <phone>00918971966903</phone>
      <email>sataksis2007@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Shekhar Patil, DM</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Radheshyam Naik, DM</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Vijay Agarwal, Phd</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ajai BS Kumar, MS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kumara Swamy, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Vikram Maiya, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ravi Nayar, MS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sataksi Chaterjee, MS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Raghavendra M Rao, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Amritanshu Ram, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <reference>
    <citation>Barringer DA, Hutcheson KA, Sturgis EM, Kies MS, Lewin JS. Effect of induction chemotherapy on speech and swallowing function in patients with oral tongue cancer. Head Neck. 2009 May;31(5):611-7. doi: 10.1002/hed.20989.</citation>
    <PMID>19107949</PMID>
  </reference>
  <reference>
    <citation>Kies MS, Boatright DH, Li G, Blumenschein G, El-Naggar AK, Brandon Gunn G, Lewin JS, Steinhaus GD, Sturgis EM. Phase II trial of induction chemotherapy followed by surgery for squamous cell carcinoma of the oral tongue in young adults. Head Neck. 2012 Sep;34(9):1255-62. doi: 10.1002/hed.21906. Epub 2011 Oct 19.</citation>
    <PMID>22009800</PMID>
  </reference>
  <reference>
    <citation>Pignon JP, le Maitre A, Maillard E, Bourhis J; MACH-NC Collaborative Group. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): an update on 93 randomised trials and 17,346 patients. Radiother Oncol. 2009 Jul;92(1):4-14. doi: 10.1016/j.radonc.2009.04.014. Epub 2009 May 14.</citation>
    <PMID>19446902</PMID>
  </reference>
  <reference>
    <citation>Blanchard P, Bourhis J, Lacas B, Posner MR, Vermorken JB, Cruz Hernandez JJ, Bourredjem A, Calais G, Paccagnella A, Hitt R, Pignon JP; Meta-Analysis of Chemotherapy in Head and Neck Cancer, Induction Project, Collaborative Group. Taxane-cisplatin-fluorouracil as induction chemotherapy in locally advanced head and neck cancers: an individual patient data meta-analysis of the meta-analysis of chemotherapy in head and neck cancer group. J Clin Oncol. 2013 Aug 10;31(23):2854-60. doi: 10.1200/JCO.2012.47.7802. Epub 2013 Jul 8.</citation>
    <PMID>23835714</PMID>
  </reference>
  <reference>
    <citation>Forastiere AA, Zhang Q, Weber RS, Maor MH, Goepfert H, Pajak TF, Morrison W, Glisson B, Trotti A, Ridge JA, Thorstad W, Wagner H, Ensley JF, Cooper JS. Long-term results of RTOG 91-11: a comparison of three nonsurgical treatment strategies to preserve the larynx in patients with locally advanced larynx cancer. J Clin Oncol. 2013 Mar 1;31(7):845-52. doi: 10.1200/JCO.2012.43.6097. Epub 2012 Nov 26.</citation>
    <PMID>23182993</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>September 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>December 2, 2016</last_update_submitted>
  <last_update_submitted_qc>December 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>HealthCare Global Enterprise Ltd.</investigator_affiliation>
    <investigator_full_name>Vishal U S Rao</investigator_full_name>
    <investigator_title>Senior Consultant</investigator_title>
  </responsible_party>
  <keyword>Neoadjuvant Chemotherapy</keyword>
  <keyword>Tongue Malignancy</keyword>
  <keyword>Squamous Cell Carcinoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Tongue Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Docetaxel</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/NCT02985255
org study id: HCG/SX/001/2016
nct id: NCT02985255
lead sponsor: 
has dmc: No
Patients enrolled for the study, who are eligible for NACT, will undergo a pre-treatment
      workup comprising of Evaluation Under Anesthesia (EUA) for tumor Mapping and tissue biopsy
      along with a PET-CT scan. Subsequently, they would undergo 3 cycles of NACT (weekly thrice)
      with DCF. They would be reassessed with PET-CT and EUA +/- biopsy after the end of the third
      cycle. Those who are achieving CR would undergo adjuvant CTRT. Subjects who have a PR in the
      PET-CT scan will be re-classified based on the biopsy report. If they remain in the PR group
      they will undergo surgery but if the biopsy in is negative for malignancy, they will undergo
      adjuvant CTRT. Those subjects with SD or PD would undergo surgery. Subsequently, further
      radiation and/ or chemotherapy will be decided based on the final histopathology (of the
      surgical specimen) reports.

      PET-CT and EUA +/- HPE analyses would be repeated on follow-up after 3 months of treatment
      completion.
Patients enrolled for the study, who are eligible for Neoadjuvant chemotherapy, will undergo
      a pre-treatment workup comprising of Evaluation Under Anesthesia (EUA) for tumor Mapping and
      tissue biopsy along with a PET-CT scan. Subsequently, they would undergo 3 cycles of
      Neoadjuvant chemotherapy (weekly thrice) with injection Docetaxel, Cisplatin, and 5-FU. They
      would be reassessed with PET-CT and EUA +/- biopsy after the end of the third cycle. Those
      who are achieving a Complete Response (CR) would undergo adjuvant chemo-radiotherapy.
      Subjects who have a partial response (PR) in the PET-CT scan will be re-classified based on
      the biopsy report. If they remain in the PR group they will undergo surgery. If the biopsy in
      these patients is negative for malignancy, they will undergo adjuvant chemoradiotherapy.
      Those subjects with stable disease (SD) or progressive disease (PD) would undergo surgery.
      Subsequently, further radiation and/ or chemotherapy will be decided based on the final
      histopathology (of the surgical specimen) reports.

      PET-CT and EUA +/- HPE analyses would be repeated on follow-up after 3 months of treatment
      completion.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Tongue Preservation Rate
time frame: At Response evaluation post 3rd CT Cycle (approximately 7 months post recruitment)
description: A ratio of the number of study subjects who have achieved a complete response and do not require surgery, after 3 cycles of NaCT to the total number of subjects recruited to the study.
measure: Overall Survival
time frame: 2 years post treatment completion
description: Overall Survival Rate (Date of diagnosis to date of death or last follow-up) in different sub-cohorts of the study
measure: Progression Free Survival
time frame: 2 years post treatment completion
description: Progression Free Survival Rate (Primary treatment end date to date of progression or last follow-up) in difference sub-cohorts of the study
measure: Sensitivity and Specificity of PET-CT
time frame: At Baseline and after 12-15 weeks (post 3 cycles of NaCT (Typically 3 weeks))
description: Ability of PETCT (along with HPE and EUA) to detect response rates in study subjects undergoing NACT for Ca Tongue
arm group label: Neoadjuvant Arm
arm group type: Experimental
description: Study Subjects, eligible for NACT would undergo a pretreatment workup with Evaluation Under Anesthesia for tumor Mapping and tissue biopsy along with a PET-CT scan. They would undergo 3 cycles of NACT (weekly thrice) with injection Docetaxel, Cisplatin and 5-FU after which reassessment with PET-CT and EUA +/- biopsy would be done. Those achieving CR would undergo adjuvant CTRT while subjects with PR in PET-CT scan will be reclassified based on the biopsy report. If biopsy is negative for malignancy, they will undergo adjuvant CTRT but would undergo surgery if in the PR group. Subjects with SD or PD would undergo surgery. PET-CT and EUA +/- HPE analyses would be repeated on follow-up after 3 months of treatment completion.
intervention type: Drug
intervention name: Docetaxel
description: Neoadjuvant Arm
arm group label: Neoadjuvant Arm
intervention type: Drug
intervention name: Cisplatin
description: Neoadjuvant Arm
arm group label: Neoadjuvant Arm
intervention type: Drug
intervention name: 5FU
description: Neoadjuvant Arm
arm group label: Neoadjuvant Arm
intervention type: Radiation
intervention name: Radiotherapy
description: Neoadjuvant Arm
arm group label: Neoadjuvant Arm
intervention type: Procedure
intervention name: Glossectomy
description: Neoadjuvant Arm
arm group label: Neoadjuvant Arm
criteria: 
gender: All
minimum age: 1 Year
maximum age: 99 Years
healthy volunteers: No
last name: Vishal US Rao, MS
role: Principal Investigator
affiliation: Dept of Head & Neck Surgery, HealthCare Global Enterprises Ltd.
last name: Vishal US Rao, MS
phone: 00919739774949
email: drvishalrao@yahoo.com
last name: Sataksi Chatterjee, MS
phone: 00918971966903
email: sataksis2007@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: India
citation: Barringer DA, Hutcheson KA, Sturgis EM, Kies MS, Lewin JS. Effect of induction chemotherapy on speech and swallowing function in patients with oral tongue cancer. Head Neck. 2009 May;31(5):611-7. doi: 10.1002/hed.20989.
PMID: 19107949
citation: Kies MS, Boatright DH, Li G, Blumenschein G, El-Naggar AK, Brandon Gunn G, Lewin JS, Steinhaus GD, Sturgis EM. Phase II trial of induction chemotherapy followed by surgery for squamous cell carcinoma of the oral tongue in young adults. Head Neck. 2012 Sep;34(9):1255-62. doi: 10.1002/hed.21906. Epub 2011 Oct 19.
PMID: 22009800
citation: Pignon JP, le Maitre A, Maillard E, Bourhis J; MACH-NC Collaborative Group. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): an update on 93 randomised trials and 17,346 patients. Radiother Oncol. 2009 Jul;92(1):4-14. doi: 10.1016/j.radonc.2009.04.014. Epub 2009 May 14.
PMID: 19446902
citation: Blanchard P, Bourhis J, Lacas B, Posner MR, Vermorken JB, Cruz Hernandez JJ, Bourredjem A, Calais G, Paccagnella A, Hitt R, Pignon JP; Meta-Analysis of Chemotherapy in Head and Neck Cancer, Induction Project, Collaborative Group. Taxane-cisplatin-fluorouracil as induction chemotherapy in locally advanced head and neck cancers: an individual patient data meta-analysis of the meta-analysis of chemotherapy in head and neck cancer group. J Clin Oncol. 2013 Aug 10;31(23):2854-60. doi: 10.1200/JCO.2012.47.7802. Epub 2013 Jul 8.
PMID: 23835714
citation: Forastiere AA, Zhang Q, Weber RS, Maor MH, Goepfert H, Pajak TF, Morrison W, Glisson B, Trotti A, Ridge JA, Thorstad W, Wagner H, Ensley JF, Cooper JS. Long-term results of RTOG 91-11: a comparison of three nonsurgical treatment strategies to preserve the larynx in patients with locally advanced larynx cancer. J Clin Oncol. 2013 Mar 1;31(7):845-52. doi: 10.1200/JCO.2012.43.6097. Epub 2012 Nov 26.
PMID: 23182993
responsible party type: Principal Investigator
investigator affiliation: HealthCare Global Enterprise Ltd.
investigator full name: Vishal U S Rao
investigator title: Senior Consultant
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Tongue Neoplasms
mesh term: Docetaxel
sharing ipd: No