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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02353260
• Other study ID #: 14-A
• Status: Recruiting
• Phase: Phase 2
• First received: January 28, 2015
• Last updated: January 30, 2015
• Start date: December 2014
• Est. completion date: September 2017

Study information

• Verified date: January 2015
• Source: Shanghai 9th People's Hospital
• Contact: Wei Guo, PhD
• Phone: 086-13901685814
• Email: guoweicn[@]yahoo.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Device:
• Ultrasound Hyperthermia
treated with Therapeutic Ultrasound device on the 1st,3rd,5th,7th,9th day of each 21 day cycle

Drug:
• Docetaxel,Cisplatin,Fluorouracil
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)

Locations

Country	Name	City	State
China	Xuzhou Central Hospital	Xuzhou	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Wei Guo	Xuzhou Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Disease Control		one year	Yes
Secondary	Progression Free Survival		three years	Yes
Secondary	Over Survival		three years	Yes