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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Neoadjuvant Arm
Neoadjuvant Arm
Neoadjuvant Arm
Neoadjuvant Arm
Neoadjuvant Arm
HealthCare Global Enterprises Ltd
Bangalore, Karnataka, India
RECRUITINGTongue Preservation Rate
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.
Time frame: At Response evaluation post 3rd CT Cycle (approximately 7 months post recruitment)
Overall Survival
Overall Survival Rate (Date of diagnosis to date of death or last follow-up) in different sub-cohorts of the study
Time frame: 2 years post treatment completion
Progression Free Survival
Progression Free Survival Rate (Primary treatment end date to date of progression or last follow-up) in difference sub-cohorts of the study
Time frame: 2 years post treatment completion
Sensitivity and Specificity of PET-CT
Ability of PETCT (along with HPE and EUA) to detect response rates in study subjects undergoing NACT for Ca Tongue
Time frame: At Baseline and after 12-15 weeks (post 3 cycles of NaCT (Typically 3 weeks))
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