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

Phase 2

• Conditions: Head and Neck Cancer
• Interventions: Device: Ultrasound Hyperthermia; Drug: Docetaxel,Cisplatin,Fluorouracil

• Registration Number: NCT02353260
• Lead Sponsor: Wei Guo

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-12
• Status Verified: 2015-01
• Study First Submitted: 2015-01-28
• Study First Submitted QC: 2015-01-30
• Last Update Submitted: 2015-01-30
• Study First Posted: 2015-02-02
• Last Update Posted: 2015-02-02
• Primary Completion: 2016-03
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound Hyperthermia+Chemotherapy	Ultrasound Hyperthermia	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
Ultrasound Hyperthermia+Chemotherapy	Docetaxel,Cisplatin,Fluorouracil	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
Chemotherapy	Docetaxel,Cisplatin,Fluorouracil	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.

Primary Outcome Measures

Name	Time	Method
Rate of Disease Control	one year

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	three years
Over Survival	three years

Trial Locations

Locations (1)

Xuzhou Central Hospital; 🇨🇳 Xuzhou, Jiangsu, China