Squamous Cell Carcinoma Clinical Trial
Official title:
Role of Neo-adjuvant Chemotherapy in Organ Preservation in Locally Advanced Squamous Cell Carcinoma of Oral Tongue
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.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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