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

Wei Guo

Status and phase: Unknown; Phase 2

Conditions: Head and Neck Cancer

Treatments: Drug: Docetaxel,Cisplatin,Fluorouracil; Device: Ultrasound Hyperthermia

Study type: Interventional

Funder types: Other

Identifiers

NCT02353260

14-A

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Ultrasound Hyperthermia+Chemotherapy

Experimental group

Description:

Chemotherapy: 1. 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) 2. 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

Treatment:

Device: Ultrasound Hyperthermia

Drug: Docetaxel,Cisplatin,Fluorouracil

Chemotherapy

Active Comparator group

Description:

Chemotherapy: 1. 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) 2. The treatments will be administrated in accord with the guideline for other types of cancer.

Treatment:

Drug: Docetaxel,Cisplatin,Fluorouracil