Tongue Neoplasms, Squamous Cell Carcinoma, Anterior Tongue Squamous Cell Carcinoma
Conditions
Keywords
Neoadjuvant Chemotherapy, Tongue Malignancy, Squamous Cell Carcinoma
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.
Interventions
DRUGDocetaxel
Neoadjuvant Arm
DRUGCisplatin
Neoadjuvant Arm
DRUG5FU
Neoadjuvant Arm
RADIATIONRadiotherapy
Neoadjuvant Arm
PROCEDUREGlossectomy
Neoadjuvant Arm
Sponsors
HealthCare Global Enterprise Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tongue Preservation Rate | At Response evaluation post 3rd CT Cycle (approximately 7 months post recruitment) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 2 years post treatment completion | Overall Survival Rate (Date of diagnosis to date of death or last follow-up) in different sub-cohorts of the study |
| Progression Free Survival | 2 years post treatment completion | Progression Free Survival Rate (Primary treatment end date to date of progression or last follow-up) in difference sub-cohorts of the study |
| Sensitivity and Specificity of PET-CT | At Baseline and after 12-15 weeks (post 3 cycles of NaCT (Typically 3 weeks)) | Ability of PETCT (along with HPE and EUA) to detect response rates in study subjects undergoing NACT for Ca Tongue |
Countries
India
Contacts
Primary ContactVishal US Rao, MS
Backup ContactSataksi Chatterjee, MS
Outcome results
None listed