Role of Neo-adjuvant Chemotherapy in Tongue Preservation in Locally Advanced Squamous Cell Carcinoma of Oral Tongue
Tongue Neoplasms, Squamous Cell Carcinoma, Anterior Tongue Squamous Cell Carcinoma
About this trial
This is an interventional treatment trial for Tongue Neoplasms focused on measuring Neoadjuvant Chemotherapy, Tongue Malignancy, Squamous Cell Carcinoma
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
Sites / Locations
- HealthCare Global Enterprises LtdRecruiting
Arms of the Study
Arm 1
Experimental
Neoadjuvant Arm
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.