Efficacy and Safety of Ultrasound Hyperthermia Combined With Chemotherapy on Oral and Maxillofacial-Head and Neck Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Ultrasound Hyperthermia is effective and safe in the treatment of Oral and Maxillofacial-Head and Neck Cancer.

Detailed Description
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As a non-invasive treatment, Ultrasound Hyperthermia has received increasing interest for the treatment of cancer.Many studies have shown that Therapeutic Ultrasound is safe and effective. Eligible patients were randomly assigned by using permutated blocks designed for each site to receive either Ultrasound Hyperthermia combined with chemotherapy (Arm A) or chemotherapy alone(Arm B).Chemotherapy will be conducted as follows. For Squamous cell carcinoma of head and neck,it will be administrated with Docetaxel(at a dose of 75 mg per square meter of body-surface area and intravenous infused in 1 hr at day 1rt), Cisplatin(at a dose of 75 mg per square meter of body-surface area and intravenous infused in 1 hr at day 1rt) and Fluorouracil(at a dose of 75 mg per square meter of body-surface area and intravenous infused last 5 days) . For other types of cancer,the treatments will be administrated in accord with the guideline.In addition,Ultrasound Hyperthermia will be conducted 5 times(day 1rt,3rd,5th,7th,9th) in Arm A. Patients in arm B will receive chemotherapy only. One cycle comprises a period of 3 weeks (21 days).All patients will receive 2 cycles in both arms. All the patients eligible for the operation will take surgery. After treatment，some patients with advanced unresectable cancer may be down-staged from stage IV, and will regain the opportunity of operation.

Official Title
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A Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Ultrasound Hyperthermia in Combination With Chemotherapy on Oral and Maxillofacial-Head and Neck Cancer

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Device: Ultrasound Hyperthermia
* Drug: Docetaxel,Cisplatin,Fluorouracil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Joined the study voluntary and signed informed consent form Age 18-75，both genders. Had histologically or cytologically confirmed advanced squamous cell carcinoma of the head and neck At least one lesions can be measured,Conventional measurements ≥2cm, computed tomography(CT) examination ≥1cm . Eastern Cooperative Oncology Group(ECOG) Performance Scale 0-2. Life expectancy of more than 6 months. Use of an effective contraceptive method for women when there is a risk of pregnancy during the study. Haemoglobin≥90g/L ,White blood cell(WBC) ≥3×10^9/L Hepatic function:ALAT、ASAT< 2.5 x ULN, TBIL< 1.5 x ULN Renal function: Creatinine < 1.5 x ULN Exclusion Criteria: Participation in other interventional clinical trials within 1 month Previous received other drug or operative treatment within 6 month Pregnant or breast-feeding women History of serious allergic or allergy Patients with the history of Serious lung or head disease Local skin ulceration

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound Hyperthermia+Chemotherapy<br>Chemotherapy: Squamous cell carcinoma of head and neck: Docetaxel(75mg/m²,d1/21d,2 cycles);Cisplatin(75mg/m²,d1/21d,2 cycles);Fluorouracil(750mg/m²/d,d1-5/21d, 2 cycles) The treatments will be administrated in accord with the guideline for other types of cancer. Ultrasound Hyperthermia: Ultrasound hyperthermia d1,3,5,7,9/21d for 2 cycles | Device: Ultrasound Hyperthermia<br>* treated with Therapeutic Ultrasound device on the 1st,3rd,5th,7th,9th day of each 21 day cycle<br>Drug: Docetaxel,Cisplatin,Fluorouracil<br>* Squamous cell carcinoma of head and neck: Docetaxel(75mg/m²,d1/21d,2 cycles);Cisplatin(75mg/m²,d1/21d,2 cycles);Fluorouracil(750mg/m²/d,d1-5/21d, 2 cycles)<br>|
| Active Comparator: Chemotherapy<br>Chemotherapy: Squamous cell carcinoma of head and neck: Docetaxel(75mg/m²,d1/21d,2 cycles);Cisplatin(75mg/m²,d1/21d,2 cycles);Fluorouracil(750mg/m²/d,d1-5/21d, 2cycles) The treatments will be administrated in accord with the guideline for other types of cancer. | Drug: Docetaxel,Cisplatin,Fluorouracil<br>* Squamous cell carcinoma of head and neck: Docetaxel(75mg/m²,d1/21d,2 cycles);Cisplatin(75mg/m²,d1/21d,2 cycles);Fluorouracil(750mg/m²/d,d1-5/21d, 2 cycles)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Disease Control |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | three years | 
| Over Survival |  | three years |