Role of Neo-adjuvant Chemotherapy in Tongue Preservation in Locally Advanced Squamous Cell Carcinoma of Oral Tongue

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Brief Title

Role of Neo-adjuvant Chemotherapy in Tongue Preservation in Locally Advanced Squamous Cell Carcinoma of Oral Tongue

Official Title

Role of Neo-adjuvant Chemotherapy in Organ Preservation in Locally Advanced Squamous Cell Carcinoma of Oral Tongue

Brief Summary

      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.

Detailed Description

      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.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Tongue Preservation Rate

Secondary Outcome

 Overall Survival

Condition

Tongue Neoplasms

Intervention

Docetaxel

Study Arms / Comparison Groups

 Neoadjuvant Arm
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

30

Start Date

April 2016

Completion Date

June 2017

Primary Completion Date

June 2017

Eligibility Criteria

        Inclusion Criteria:

          -  Patients of newly diagnosed squamous cell carcinoma (well/ moderately/ poorly
             differentiated) of oral tongue (anterior two third) presenting to Health Care Global
             Enterprises Ltd between January 2016 to March 2017 will be included in the study.

          -  Stage III and stage IV (T3, 4 N0-3, M 0) and selected cases of T2 with advanced nodal
             status will also be included in the study.

        Exclusion Criteria:

          -  Patients having recurrence/ residual disease of oral tongue.

          -  Patients who have received alternative treatments before being evaluated for NACT

          -  Patient who are not fit for NACT

          -  Patient not able to give consent

Gender

All

Ages

1 Year - 99 Years

Accepts Healthy Volunteers

No

Contacts

Vishal US Rao, MS, 00919739774949, [email protected]

Location Countries

India

Location Countries

India

Administrative Informations

NCT ID

NCT02985255

Organization ID

HCG/SX/001/2016

Responsible Party

Principal Investigator

Study Sponsor

HealthCare Global Enterprise Ltd.

Study Sponsor

Vishal US Rao, MS, Principal Investigator, Dept of Head & Neck Surgery, HealthCare Global Enterprises Ltd.

Verification Date

December 2016