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

HealthCare Global

Status and phase: Unknown; Phase 2

Conditions: Squamous Cell Carcinoma; Anterior Tongue Squamous Cell Carcinoma; Tongue Neoplasms

Treatments: Drug: Cisplatin; Procedure: Glossectomy; Drug: 5FU; Radiation: Radiotherapy; Drug: Docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02985255

HCG/SX/001/2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 1 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Neoadjuvant Arm

Experimental group

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.

Treatment:

Procedure: Glossectomy

Radiation: Radiotherapy

Drug: Docetaxel

Drug: 5FU

Drug: Cisplatin