Concomitant Chemoradiotherapy (CCRT) With Weekly Docetaxel and Cisplatin for Locally Advanced Head and Neck Cancer

Study Overview
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Brief Summary
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This phase II trial is evaluating the efficacy of concurrent chemoradiation therapy with weekly docetaxel and cisplatin combination regimen.

Detailed Description
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Many studies have shown the superiority of concurrent chemoradiotherapy over radiotherapy only in locally advanced head and neck cancer. Concurrent chemoradiotherapy with high dose cisplatin has been universally used regimen. In a large-scaled phase II trial, however, conducted by the European Organization for the Research and Treatment of Cancer (EORTC), docetaxel (100mg/m2) plus cisplatin (75mg/ m2) every three weeks regimen produced improved survival, nonetheless there was significant limitation to deliver full doses of treatment due to significant hematologic and non-hematologic toxicities. Previously, we showed the safety of the combination regimen of weekly docetaxel and cisplatin in concurrent chemoradiation treatment in a phase I study. We determined the MTD of docetaxel to be 20mg/m2 weekly when concurrently administered with conventional fractionation RT and weekly 20mg/m2 of cisplatin.

Official Title
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A Phase II Trial of Concurrent Chemoradiotherapy With Weekly Docetaxel and Cisplatin for Locally Advanced Head and Neck Cancer

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Drug: CCRT with weekly docetaxel & cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed squamous cell carcinoma of the head and neck (SCCHN) of one of following sites : oral cavity, oropharynx, larynx, or hypopharynx Unresectable Stage III - ⅣB disease previously untreated for head & Neck cancer with chemotherapy or radiotherapy 18 and over Performance status ECOG 0-1 Absolute neutrophil count ≥ 1,500/mm3 Platelet count ≥ 75,000/mm3 Hemoglobin > 9.0 g/dL Bilirubin ≤ 1.5 times upper limit of normal (ULN) AST or ALT, and alkaline phosphatase meeting 1 of the following parameters:Alkaline phosphatase ≤ 1.5 times ULN AND AST or ALT ≤ 5 times ULN Alkaline phosphatase ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN Alkaline phosphatase ≤ 5 times ULN AND AST or ALT ≤ ULN serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 60 ml/min Exclusion Criteria: Distant metastatic disease (M1) Prior chemotherapy or RT for Head and neck cancer Synchronous or concurrent head and neck primary tumors Lip, nasopharynx, nasal cavity, salivary gland, or sinuses No other invasive malignancy within the past 3 years except nonmelanoma skin cancer or papillary thyroid cancer Other concurrent illness that would preclude study participation Other concurrent physical condition (e.g., infectious disease) that would preclude study participation pregnant or nursing Fertile patients must use effective contraception during and for 3 months after study participation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: weekly docetaxel and cisplatin<br> | Drug: CCRT with weekly docetaxel & cisplatin<br>* radiotherapy: 70Gy/35 fraction for 7 weeks chemotherapy: docetaxel 20mg/m2 and cisplatin 20mg/m2 weekly for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response rate |  | 3-4 weeks after completion of CCRT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life |  | Pretreatment & 3-4 weeks after completion of treatment | 
| overall survival rate |  | 2 year | 
| disease free survival rate |  | 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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locally advanced Squamous cell carcinoma