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

• ClinicalTrials.gov Identifier: NCT02353260
• Recruitment Status: Unknown
• First Posted: February 2, 2015
• Last Update Posted: February 2, 2015
• Sponsor: Wei Guo
• Collaborator: Xuzhou Central Hospital
• Information provided by (Responsible Party): Wei Guo, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Tracking Information

• First Submitted Date: January 28, 2015
• First Posted Date: February 2, 2015
• Last Update Posted Date: February 2, 2015
• Study Start Date: December 2014
• Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 30, 2015): Rate of Disease Control [ Time Frame: one year ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: January 30, 2015)

• Progression Free Survival [ Time Frame: three years ]
• Over Survival [ Time Frame: three years ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy and Safety of Ultrasound Hyperthermia Combined With Chemotherapy on Oral and Maxillofacial-Head and Neck Cancer
• 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
• 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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Head and Neck Cancer

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)

Study Arms

• 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

  Interventions:

  • Device: Ultrasound Hyperthermia
  • Drug: Docetaxel,Cisplatin,Fluorouracil
• 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.
  Intervention: Drug: Docetaxel,Cisplatin,Fluorouracil

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 30, 2015): 120
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2017
• Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02353260
• Other Study ID Numbers: 14-A
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Wei Guo, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Original Responsible Party: Same as current
• Current Study Sponsor: Wei Guo
• Original Study Sponsor: Same as current
• Collaborators: Xuzhou Central Hospital

Investigators

• Study Chair: Wei Guo, PhD; Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

• PRS Account: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Verification Date: January 2015