Trial of Neoadjuvant Therapy With Paclitaxel and Carboplatin in Operable Locally Advanced Head and Neck Cancer Patients
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Interventions
- Drug: paclitaxel/carboplatin
- Registration Number
- NCT05294900
- Lead Sponsor
- Yonsei University
- Brief 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"
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 79
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description paclitaxel/carboplatin paclitaxel/carboplatin paclitaxel+carboplatin
- Primary Outcome Measures
Name Time Method Major pathologic response(mPR) up to 9weeks after completion of the induction chemotherapy
- Secondary Outcome Measures
Name Time Method Overall survival (OS) Up to 1 years Loco-regional relapse rate(LRR) up to 9weeks after completion of the induction chemotherapy Relapse-free survival(RFS) Up to 1 years
Trial Locations
- Locations (1)
Yonsei University Health System, Severance Hospital
🇰🇷Seoul, Korea, Republic of