NCT02353260

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for phase_2 head-and-neck-cancer

Timeline
Completed

Started Dec 2014

Shorter than P25 for phase_2 head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 2, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

February 2, 2015

Status Verified

January 1, 2015

Enrollment Period

1.2 years

First QC Date

January 28, 2015

Last Update Submit

January 30, 2015

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

  • Rate of Disease Control

    one year

Secondary Outcomes (2)

  • Progression Free Survival

    three years

  • Over Survival

    three years

Study Arms (2)

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

Device: Ultrasound HyperthermiaDrug: 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.

Drug: Docetaxel,Cisplatin,Fluorouracil

Interventions

Ultrasound HyperthermiaDEVICE

treated with Therapeutic Ultrasound device on the 1st,3rd,5th,7th,9th day of each 21 day cycle

Ultrasound Hyperthermia+Chemotherapy
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)

ChemotherapyUltrasound Hyperthermia+Chemotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuzhou Central Hospital

Xuzhou, Jiangsu, 221000, China

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

DocetaxelCF regimen

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Wei Guo, PhD

    Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

    STUDY CHAIR

Central Study Contacts

Wei Guo, PhD

CONTACT

086-13901685814guoweicn@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director in Dept.of Oral and Maxillofacial-Head and Neck Oncology

Study Record Dates

First Submitted

January 28, 2015

First Posted

February 2, 2015

Study Start

December 1, 2014

Primary Completion

March 1, 2016

Study Completion

September 1, 2017

Last Updated

February 2, 2015

Record last verified: 2015-01

Locations

CN(1)