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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02353260
Recruitment Status : Unknown
Verified January 2015 by Wei Guo, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.
Recruitment status was:  Recruiting
First Posted : February 2, 2015
Last Update Posted : February 2, 2015
Sponsor:
Collaborator:
Xuzhou Central Hospital
Information provided by (Responsible Party):
Wei Guo, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Device: Ultrasound Hyperthermia Drug: Docetaxel,Cisplatin,Fluorouracil Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Study Start Date : December 2014
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Ultrasound Hyperthermia+Chemotherapy

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

 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)
Active Comparator: Chemotherapy

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.
 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)


Outcome Measures
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Primary Outcome Measures :
  1. Rate of Disease Control [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: three years ]
  2. Over Survival [ Time Frame: three years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02353260


Contacts
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Contact: Wei Guo, PhD 086-13901685814 guoweicn@yahoo.com

Locations
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China, Jiangsu
Xuzhou Central Hospital Recruiting
Xuzhou, Jiangsu, China, 221000
Contact: Jian Meng, MD         
Principal Investigator: Jian Meng, MD         
Sponsors and Collaborators
Wei Guo
Xuzhou Central Hospital
Investigators
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Study Chair: Wei Guo, PhD Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
More Information
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Responsible Party: Wei Guo, Director in Dept.of Oral and Maxillofacial-Head and Neck Oncology, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
ClinicalTrials.gov Identifier: NCT02353260    
Other Study ID Numbers: 14-A
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: February 2, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Hyperthermia
Neoplasms by Site
Neoplasms
Body Temperature Changes
Heat Stress Disorders
Wounds and Injuries
Docetaxel
Fluorouracil
Antineoplastic Agents
 Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs