NCT02985255

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: HealthCare Global Enterprise Ltd. · Industry
• Sex: All
• Age: 1 Year – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tongue Neoplasms
• Squamous Cell Carcinoma
• Anterior Tongue Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Docetaxel	Neoadjuvant Arm
DRUG	Cisplatin	Neoadjuvant Arm
DRUG	5FU	Neoadjuvant Arm
RADIATION	Radiotherapy	Neoadjuvant Arm
PROCEDURE	Glossectomy	Neoadjuvant Arm

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2016-12-07
• Last updated: 2016-12-07

Locations

1 site across 1 country: India