Postoperative Concurrent Chemoradiotherapy With Docetaxel for High-Risk Squamous Cell Carcinoma of Head and Neck

Study Overview
=================
Brief Summary
-----------------
This is a non-randomized, phase II, open label study of postoperative concurrent chemoradiotherapy with docetaxel for high-risk squamous cell carcinoma of the head and neck(HNSCC).The primary purpose of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy with docetaxel in HNSCC patients.

Official Title
-----------------
Postoperative Concurrent Chemoradiotherapy With Docetaxel for High-Risk Squamous Cell Carcinoma of Head and Neck，A Non-Randomized Phase II Trial

Conditions
-----------------
Head-and-neck Cancer, Squamous Cell Carcinoma

Intervention / Treatment
-----------------
* Drug: Docetaxel
* Radiation: Intensity-modulated radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed squamous cell carcinoma of the head and neck.Site of tumor origin in the oral cavity, oropharynx, larynx, or hypopharynx (excluding nasopharynx, or sinuses) Gross total resection, with pathology demonstrating one or more of the following risk factors: Histologic extracapsular nodal extension Histologic involvement of ≥ 2 regional lymph nodes Invasive cancer seen on microscopic evaluation of the resection margin, with no evidence of gross tumor residual No evidence of distant metastases No synchronous or concurrent head and neck primary tumors Karnofsky score over 60 Adequate organ function including the following: Absolute neutrophil count (ANC) >= 1.5 * 10^9/l Platelets count >= 100 * 10^9/l Hemoglobin >= 10 g/dl AST and ALT <= 2.5 times institutional upper limit of normal (ULN) Total bilirubin <= 1.5 times institutional ULN Creatinine clearance >= 50 ml/min Serum creatine <= 1 times ULN Signed written informed consent Exclusion Criteria: Evidence of distant metastasis Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Docetaxel Group<br>Concurrent Chemoradiotherapy With Docetaxel | Drug: Docetaxel<br>* Docetaxel: 20mg/m2/w for 6 weeks<br>Radiation: Intensity-modulated radiotherapy<br>* a total dose of 60Gy in 30 fractions over 6 weeks<br>* Other names: IMRT;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival | from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival rate | from date of enrollment until date of first death from any cause, assessed up to 2 years | 2 years | 
| Acute toxicity profiles, graded according to the NCI CTCAE version 3.0 | Number of participants with treatment-related acute toxicity as assessed weekly by CTCAE v3.0 during the course of treatment | up to 6-7 weeks | 
| Late toxicity profiles, graded according to the NCI CTCAE version 3.0 | Number of participants with treatment-related late toxicity as assessed every 3 months by CTCAE v3.0 up to 2 years | up to 2 years | 
| Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Core 35 (EORTC QLQ-HN35) during the concurrent treatment | QoL score will be documented on each weekend during the course of radiotherapy | participants will be followed for the duration of hospital stay, an expected average of 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Docetaxel, Concurrent Chemoradiotherapy, High-Risk, Squamous Cell Carcinoma, Head-and-Neck Cancer