Head and Neck CancerPhase 2NCT02353260
Efficacy and Safety of Ultrasound Hyperthermia Combined With Chemotherapy on Oral and Maxillofacial-Head and Neck Cancer
A Phase 2 study testing Ultrasound Hyperthermia and Docetaxel,Cisplatin,Fluorouracil in people with Head and Neck Cancer, run by Wei Guo at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Ultrasound Hyperthermia and Docetaxel,Cisplatin,Fluorouracil
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Dec 2014to Sep 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221000
Jian Meng, MD
Jian Meng, MD
About this study
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
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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- Ultrasound Hyperthermia, Docetaxel,Cisplatin,Fluorouracil
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound HyperthermiaDevice
treated with Therapeutic Ultrasound device on the 1st,3rd,5th,7th,9th day of each 21 day cycle
Docetaxel,Cisplatin,FluorouracilDrug
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 group | Role | What they receive |
|---|---|---|
| Ultrasound Hyperthermia+Chemotherapy | Experimental | 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 Receives: Device: Ultrasound Hyperthermia; Drug: Docetaxel,Cisplatin,Fluorouracil |
| Chemotherapy | Active comparator | 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. Receives: Drug: Docetaxel,Cisplatin,Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Disease Control
Measured: one year
Secondary outcomes (2)
Progression Free Survival
Measured: three years
Over Survival
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startDec 2014
- Primary completionMar 2016 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wei Guo
- Sponsor type
- University, hospital or other
- Collaborators
- Xuzhou Central Hospital
- Responsible party
- Sponsor-investigator, Wei Guo, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Investigators
- Wei Guo, PhD, Study chair, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02353260
- Sponsor's protocol ID
- 14-A
- Status last verified
- Jan 2015
- First submitted
- 28 Jan 2015
- Last updated
- 2 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02353260
- Acronym / sponsor ID
- 14-A
- Conditions
- Head and Neck Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Wei GuoUniversity, hospital or other
- Collaborators
- Xuzhou Central Hospital
- Study start
- Dec 2014
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 2 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Hyperthermia+Chemotherapy | Experimental | Device: Ultrasound Hyperthermia, Drug: Docetaxel,Cisplatin,FluorouracilChemotherapy: 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 | Active comparator | Drug: Docetaxel,Cisplatin,FluorouracilChemotherapy: 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound Hyperthermiatreated with Therapeutic Ultrasound device on the 1st,3rd,5th,7th,9th day of each 21 day cycle | Device | Ultrasound Hyperthermia+Chemotherapy |
| Docetaxel,Cisplatin,FluorouracilSquamous 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) | Drug | Chemotherapy, Ultrasound Hyperthermia+Chemotherapy |
Primary outcome
Rate of Disease Control
Time frame: one year
2 secondary outcomes
Progression Free Survival
Time frame: three years
Over Survival
Time frame: three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Guo, PhD study chair
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ultrasound Hyperthermia and Docetaxel,Cisplatin,Fluorouracil in people with Head and Neck Cancer, run by Wei Guo at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Guo, PhD (086-13901685814, guoweicn@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Disease Control (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2015.