Concurrent Chemoradiotherapy(CRT) in Locally Advanced(LA) SCCHN vs Cetuximab With Radiotherapy (RT) After Neoadjuvant Chemotherapy

Study Overview
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Brief Summary
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Verify the effect and the incidence of oral mucositis of concurrent chemoradiotherapy in locally advanced squamous cell carcinoma of the head and neck versus concomitant cetuximab with radiotherapy after neoadjuvant chemotherapy. The predictive effect of Apurinic/apyrimidinic endonuclease 1(APE1)/ Ref-1 protein and Apurinic/apyrimidinic endonuclease 1(APE1)/Ref-1 antibody on oral mucositis.

Official Title
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Concurrent Chemoradiotherapy in Locally Advanced Squamous Cell Carcinoma of the Head and Neck Versus Concomitant Cetuximab With Radiotherapy After Neoadjuvant Chemotherapy: a Randomized, Opened, Multicenter Phase II Trial

Conditions
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Carcinoma, Squamous Cell of Head and Neck

Intervention / Treatment
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* Drug: Cetuximab
* Radiation: radiation
* Drug: Docetaxel
* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed first diagnosis of locally advanced squamous cell carcinoma of the head and neck Imaging (MRI, CT, bone scan) stage Ⅲ、Ⅳa (T1-2N2M0、T3N0-2M0、T4N0-2M0) (2010AJCC staging criteria) 18 years of age or older Presence of at least 1 measurable lesion according to RECIST version1.1 DON'T accept surgery, chemotherapy or irradiation before trial entry Eastern Cooperative Oncology Group(ECOG) 0 or 1 Expected survival period over 6months Before RT randomization, bone marrow and liver and kidney function in patients with meet the following criteria: Hemoglobin(HB) ≥ 100g/L, neutrophil ≥ 2.0 × 109/L and platelet ≥ 100 × 109/L Total bilirubin ≤ 1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 times the upper limit of normal; More than 1.5 times the upper limit of normal serum creatinine or creatinine clearance rate ≥ 60 ml/min, urea N ≤ 200mg/L; The blood glucose level: good blood glucose control, fasting glucose, 3.9-7.2mmol/L postprandial blood glucose less than 10.0mmol/L, HbA1c < 7%; Signed written informed consent before any trail-related activities are carried out. Exclusion Criteria: Patients accepted chemotherapy、radiotherapy or surgery; Distant metastasis before trail entry Female subjects who are pregnant or breast feeding; oral mucositis or oral mucositis has repeatedly made (1 times / month or more)before Chemotherapy or radiotherapy ; With teeth periodontitis; Any investigational medication within 30 days before trial entry; Elderly patients with dry stomatitis; Any unstable system diseases: including active infection, uncontrolled hypertension, unstable angina pectoris, within the last 3 months of the onset of angina, congestive heart failure, the group in June before the myocardial infarction, need serious mental disorder drug treatment, liver, kidney or metabolic diseases; mental / spiritual diseases such as Alzheimer's disease; Total bilirubin > 1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2.5 times the upper limit of normal; On gastrointestinal physiology is not perfect, or absorb the obstacle syndrome, or unable to tolerate oral medication, or active peptic ulcer； Past or current history of neoplasm oher than squamous cell carcinoma of the head and neck; Judgment according to the researchers, there are serious harm to patient safety or affect the patients completed the study with the disease, and patient compliance with the difference; known human immunodeficiency virus (HIV) infection; With immunodeficiency disease, or suffer from other acquired, congenital immunodeficiency disease, or a history of organ transplantation; Any disease, metabolic disorders, or physical examination or laboratory suspicion or treatment of complications in patients at high risk of drug.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RT concurrent with cetuximab<br>Selected 60 patients with locally advanced squamous cell carcinoma of the head and neck. They will be randomized to concurrent chemoradiotherapy versus concomitant cetuximab with radiotherapy after neoadjuvant chemotherapy.To observe the curative effect of the treatment of the cetuximab | Drug: Cetuximab<br> <br> Radiation: radiation<br> <br> |
| Experimental: RT concurrent with TP<br>Selected 60 patients with locally advanced squamous cell carcinoma of the head and neck. They will be randomized to concurrent chemoradiotherapy versus concomitant cetuximab with radiotherapy after neoadjuvant chemotherapy. To observe the curative effect of concurrent radiotherapy and chemotherapy | Radiation: radiation<br> <br> Drug: Docetaxel<br> <br> Drug: Cisplatin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 13 months | 
| incidence of oral mucositis |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 5 years | 
| Overall response rate after induction chemotherapy |  | 1 month |