- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02523365
HepaSphere Interventional Therapy Using Digital Subtraction Angiography(DSA) for Cervical Carcinoma
August 26, 2016 updated by: Fuda Cancer Hospital, Guangzhou
HepaSphere Interventional Therapy Using Digital Subtraction Angiography(DSA) for Cervical Carcinoma: Clinical Trial
The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional therapy using digital subtraction angiography(DSA) for cervical carcinoma.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
By enrolling patients with cervical carcinoma adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of HepaSphere interventional therapy using digital subtraction angiography(DSA) for cervical carcinoma.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510000
- Central laboratory in Fuda cancer hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age:18-80
- Karnofsky performance status >60
- Diagnosis of cervical carcinoma based on histology or the current accepted radiological measures.
- Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
- Will receive interventional therapy
- Life expectancy: Greater than 3 months
- Patients' routine blood test, liver function and kidney function have no obvious abnormalities
- Ability to understand the study protocol and a willingness to sign a written informed consent document
Exclusion Criteria:
- Patients with other primary tumor except cervical carcinoma
- History of coagulation disorders or anemia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HepaSphere
cervical carcinoma patients received HepaSphere interventional therapy using the digital subtraction angiography(DSA)
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cervical carcinoma patients received HepaSphere interventional therapy using the digital subtraction angiography(DSA)
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Placebo Comparator: control
cervical carcinoma patients received traditional therapy
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cervical carcinoma patients received HepaSphere interventional therapy using the digital subtraction angiography(DSA)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with Adverse events
Time Frame: 1 year
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1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progress free disease (PFS)
Time Frame: 1 year
|
1 year
|
Percentage of lesions interventional therapy that show no sign of recurrence 12 months after
Time Frame: 1 year
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1 year
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Overall survival (OS)
Time Frame: 3 year
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3 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
August 1, 2016
Study Registration Dates
First Submitted
August 12, 2015
First Submitted That Met QC Criteria
August 12, 2015
First Posted (Estimate)
August 14, 2015
Study Record Updates
Last Update Posted (Estimate)
August 29, 2016
Last Update Submitted That Met QC Criteria
August 26, 2016
Last Verified
October 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Cervical Carcinoma HepaSphere
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervical Carcinoma
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National Cancer Institute (NCI)TerminatedCervical Adenocarcinoma | Cervical Adenosquamous Carcinoma | Cervical Carcinoma | Cervical Carcinoma, Non-SquamousTypeUnited States
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National Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Adenosquamous Carcinoma | Cervical Squamous Cell Carcinoma | Recurrent Cervical Carcinoma | Stage IVA Cervical Cancer | Stage IVB Cervical Cancer | Stage IIIA Cervical Cancer | Stage IIIB Cervical CancerCanada
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Zhujiang HospitalUnknownStudy of Nimotuzumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Cervical CancerNeoplasms | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer | Cervical Adenosquamous Cell Carcinoma | Cervical Squamous Cell Carcinoma in SituChina
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National Cancer Institute (NCI)NRG OncologyCompletedCervical Adenocarcinoma | Cervical Adenosquamous Carcinoma | Cervical Squamous Cell Carcinoma | Recurrent Cervical Carcinoma | Cervical Small Cell Carcinoma | Stage III Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical CancerUnited States
-
National Cancer Institute (NCI)Gynecologic Oncology Group; NCIC Clinical Trials GroupTerminatedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer | Cervical Adenosquamous Cell CarcinomaUnited States, Canada
-
University of WashingtonNational Cancer Institute (NCI); National Institutes of Health (NIH)TerminatedCervical Adenocarcinoma | Cervical Adenosquamous Carcinoma | Cervical Squamous Cell Carcinoma, Not Otherwise Specified | Recurrent Cervical Carcinoma | Cervical Undifferentiated Carcinoma | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer | Stage... and other conditionsUnited States, Hong Kong, Canada
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Adenosquamous Carcinoma | Cervical Squamous Cell Carcinoma | Cervical Small Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical CancerUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Adenosquamous Carcinoma | Cervical Squamous Cell Carcinoma | Cervical Small Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical CancerUnited States
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National Cancer Institute (NCI)CompletedOxaliplatin and Paclitaxel in Treating Patients With Locally Recurrent or Metastatic Cervical CancerCervical Adenocarcinoma | Cervical Adenosquamous Carcinoma | Cervical Squamous Cell Carcinoma | Recurrent Cervical Carcinoma | Stage IVA Cervical Cancer | Stage IVB Cervical CancerUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)TerminatedLymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical CancerCervical Adenocarcinoma | Cervical Adenosquamous Carcinoma | Cervical Squamous Cell Carcinoma | Stage I Cervical CancerUnited States
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