Clinical trial · Interventional
Efficacy and Safety of Ultrasound Hyperthermia Combined With Chemotherapy on Oral and Maxillofacial-Head and Neck Cancer
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
NCT02353260CI-TRIAL-00016754unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel,Cisplatin,Fluorouracil | Drug | — | UNRESOLVED |
| Ultrasound Hyperthermia | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ultrasound Hyperthermia+Chemotherapy
- description
- 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
- interventionNames
- Device: Ultrasound Hyperthermia
- Drug: Docetaxel,Cisplatin,Fluorouracil
- type
- ACTIVE_COMPARATOR
- label
- Chemotherapy
- description
- 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.
- interventionNames
- Drug: Docetaxel,Cisplatin,Fluorouracil
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.