NCT05294900

Trial of Neoadjuvant Therapy With Paclitaxel and Carboplatin in Operable Locally Advanced Head and Neck Cancer Patients

Phase II Trial of Neoadjuvant Therapy With Paclitaxel and Carboplatin in Operable Locally Advanced Head and Neck Cancer Patients (NEOS)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 79 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

\- Objective: Primary objective: To evaluate the major pathologic response (mPR) of locally advanced head and neck cancer after paclitaxel and carboplatin-induction chemotherapy followed by surgery. Secondary objective: To evaluate the efficacy and safety of induction chemotherapy. Outcome metrics: Local relapse rate (LRR), Relapse-free survival (RFS), Overall survival (OS), Adverse reactions according to CTCAE 5.0 Exploratory Purpose: To evaluate changes in circulating tumor cells (CTC) and immunodynamics before and after paclitaxel and carboplatin-induction chemotherapy through blood, biopsy specimens, and surgical specimen analysis. * background : * Chemoradiation (CRT) or chemotherapy (Induction Chemotherapy (IC) + CRT) after induction chemotherapy has been performed for locally advanced head and neck cancer that cannot be operated immediately or for organ function preservation. . * The efficacy of induction chemotherapy before chemotherapy has been controversial because the results of several phase 3 clinical studies are inconsistent. At present, it is difficult to assert the superiority of either the addition of induction chemotherapy or radiation therapy alone, but in certain subgroups (advanced N stage such as N2c/N3) induction chemotherapy is a useful option to lower distant metastases. I can do it. * As a result of the TAX324 clinical trial, when weekly carboplatin-based chemotherapy or surgery was performed after adjuvant Docetaxel + Cisplatin + 5FU chemotherapy, overall survival was improved compared to Cisplatin + 5FU (HR 0.7, p=0.0058), It resulted in improvement of institutional retention rate (3 year LFS: 52% vs 32%). However, it is difficult to apply this TPF therapy to all patients in actual clinical practice due to the toxicity (neutropenia, nephrotoxicity) and the limitation of anticancer radiation. * In a retrospective study, in the case of adjuvant paclitaxel + carboplatin, there was no difference in progression-free survival compared to TPF (p=0.15), and there was no statistically significant decrease in the local recurrence rate (HR 0.27, p = 0.04). Confirmed. * Therefore, in this study, when paclitaxel and carboplatin-induction chemotherapy followed by surgery and chemotherapy after surgery, compared to standard TPF-induced chemotherapy, it is expected that the clinical outcome will be improved with less toxicity. * Hypothesis: Paclitaxel and carboplatin-induction chemotherapy followed by surgery, followed by chemo-radiation after surgery according to standard guidelines Compared with the existing standard treatment (TCF), improvement of clinical outcome with less toxicity * Study procedure * Induction chemotherapy Paclitaxel 175mg/m2 + Carboplatin AUC5 (calculated by Cockcroft - Gault formula) Combination therapy A total of 2 intravenous infusions every 3 weeks Surgery performed within 2-9 weeks after induction chemotherapy * surgery The surgery in this study means a complete resection for the purpose of a complete cure, and aims for a minimally invasive surgery.

Detailed description

o Induction chemotherapy Paclitaxel 175mg/m2 + Carboplatin AUC5 (calculated by Cockcroft - Gault formula) Combination therapy A total of 2 intravenous infusions every 3 weeks"

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	paclitaxel/carboplatin	Induction chemotherapy : total 2 cycle every 3weeks as below: * Paclitaxel 175mg/m2 * Carboplatin AUC5

Timeline

• Start date: 2022-05-01
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2022-03-24
• Last updated: 2022-03-25

Locations

1 site across 1 country: South Korea