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

• Status: Unknown status
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Wei Guo
• Collaborator: Xuzhou Central Hospital
• Treatments: Cisplatin; Docetaxel; Fluorouracil

Criteria

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