Head and Neck CancerNCT03450447
Outcomes of A Novel Treatment Decision of Patients With Esophageal and Head and Neck Carcinoma Synchronously
An observational study of Head and Neck Cancer and Esophageal Cancer Stage, run by Yanqing Li at 1 site in China.
Trial summary
To summarise the outcomes of a treatment decision of patients with superficial esophageal carcinoma synchronously associated with head and neck cancer, that is endoscopic treatment for the superficial esophageal carcinoma plus surgery of the head and neck carcinoma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Head and Neck Cancer, Esophageal Cancer Stage
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2018to 7 May 2020
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with head and ncek carcinoma and synchronous superficial esophageal squamous cell carcinoma.
Who may be able to join
- Patients with head and ncek carcinoma associated with synchronous superficial esophageal squamous cell carcinoma.
- Patients agree to be treated with esophageal endoscopic submucosal dissection firstly, then accept surgery of head and neck carcinoma.
Who cannot join
- Patients refuse a endoscopic submucosal dissection or surgery.
- Patients with sever systemic disease, such as sever cardiopulmonary disease, renal failure and impaired blood coagulation.
- Obstruction of the pharynx leading to a failure of insertion of endoscopy.
- Patients with an advanced esophageal carcinoma evaluated by endoscopy.
Trial locations and contacts
1 site in 1 country.
China1 site
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Guanjun Kou, 18560086107, kouguanjun88@126.com
About this study
Official title: Outcomes of a Novel Treatment Decision of Patients With Superficial Esophageal Carcinoma Synchronously Associated With Head and Neck Cancer
To summarise the outcomes of a treatment decision of patients with superficial esophageal carcinoma synchronously associated with head and neck cancer, that is endoscopic treatment for the superficial esophageal carcinoma plus surgery of the head and neck carcinoma.
Read the detailed description
As a same risk factor, such as heavy drinking and smoking, patients with head and ncek carcinoma are always suffering from synchronous esophageal squamous cell carcinoma. Previous studies illustrated that many patients with multiple esophageal lesions of early stage. In clinical practice, those patients are treated by extensive surgical resection of total pharyngo-laryngo-esophagectomy plus free jejunum interposition or gastric tube, then followed by chemoradiotherapy as standard treatment, resulting in a low quality of life for the patients, and due to the above mentioned disadvantages, many patients with synchronous superficial esophageal squamous cell carcinoma and head and neck carcinoma refused the surgery treatment. Our aims is to summarize the the outcomes of endoscopic treatment for the superficial esophageal carcinoma plus surgery of head and neck carcinoma.
- Conditions
- Head and Neck Cancer, Esophageal Cancer Stage
- Keywords
- Head and Neck Cancer, Esophageal Cancer, endoscopic submucosal dissection, quality of life, median survival time
- Medical subject headings
- Head and Neck Neoplasms, Esophageal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The first day of food intake of enrolled patients
The first day of food intake after surgery of the head and neck carcinoma
Measured: An average of 1week
Secondary outcomes (4)
The relapse rate of the enrolled patients
the relapse rate of esophageal cancer or head and neck carcinoma respectively of the enrolled patients.
Measured: an average of 2 years
The hospital stay of enrolled patients
The total hospital stay during the first hospitalization of the enrolled patients
Measured: An average of 1 month.
The incidence of stenosis
The average interval of the stenosis
Measured: an average of 2 years
The severity of stenosis
The average diameter of the stenosis
Measured: an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start10 Mar 2018 (estimated)
- Primary completion7 Feb 2020 (estimated)
- Study completion7 May 2020 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yanqing Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yanqing Li, Shandong University
- Investigators
- Yanqing Li, Study director, Department of Gastroenterology, Qilu Hospital, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450447
- Sponsor's protocol ID
- 2018SDU-QILU-G02
- Status last verified
- Feb 2018
- First submitted
- 10 Feb 2018
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all the clinical features of the patient are available to all the researchers
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of a Novel Treatment Decision of Patients With Superficial Esophageal Carcinoma Synchronously Associated With Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT03450447
- Acronym / sponsor ID
- 2018SDU-QILU-G02
- Conditions
- Head and Neck Cancer, Esophageal Cancer Stage
- Keywords
- Head and Neck Cancer, Esophageal Cancer, endoscopic submucosal dissection, quality of life, median survival time
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Yanqing LiUniversity, hospital or other
- Study start
- 10 Mar 2018 (estimated)
- Primary completion
- 7 Feb 2020 (estimated)
- Study completion
- 7 May 2020 (estimated)
- First posted
- 1 Mar 2018 (actual)
- 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.
To summarise the outcomes of a treatment decision of patients with superficial esophageal carcinoma synchronously associated with head and neck cancer, that is endoscopic treatment for the superficial esophageal carcinoma plus surgery of the head and neck carcinoma.
Detailed description
As a same risk factor, such as heavy drinking and smoking, patients with head and ncek carcinoma are always suffering from synchronous esophageal squamous cell carcinoma. Previous studies illustrated that many patients with multiple esophageal lesions of early stage. In clinical practice, those patients are treated by extensive surgical resection of total pharyngo-laryngo-esophagectomy plus free jejunum interposition or gastric tube, then followed by chemoradiotherapy as standard treatment, resulting in a low quality of life for the patients, and due to the above mentioned disadvantages, many patients with synchronous superficial esophageal squamous cell carcinoma and head and neck carcinoma refused the surgery treatment. Our aims is to summarize the the outcomes of endoscopic treatment for the superficial esophageal carcinoma plus surgery of head and neck carcinoma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with head and ncek carcinoma and synchronous superficial esophageal squamous cell carcinoma.
Key inclusion criteria (2 listed)
- Patients with head and ncek carcinoma associated with synchronous superficial esophageal squamous cell carcinoma.
- Patients agree to be treated with esophageal endoscopic submucosal dissection firstly, then accept surgery of head and neck carcinoma.
Key exclusion criteria (4 listed)
- Patients refuse a endoscopic submucosal dissection or surgery.
- Patients with sever systemic disease, such as sever cardiopulmonary disease, renal failure and impaired blood coagulation.
- Obstruction of the pharynx leading to a failure of insertion of endoscopy.
- Patients with an advanced esophageal carcinoma evaluated by endoscopy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The first day of food intake of enrolled patients
Time frame: An average of 1week
The first day of food intake after surgery of the head and neck carcinoma
4 secondary outcomes
The relapse rate of the enrolled patients
Time frame: an average of 2 years
The hospital stay of enrolled patients
Time frame: An average of 1 month.
The incidence of stenosis
Time frame: an average of 2 years
The severity of stenosis
Time frame: an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
- Individual participant dataSharing planned: Yes. all the clinical features of the patient are available to all the researchers
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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.
Yanqing Li study director
Department of Gastroenterology, Qilu Hospital, Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Esophageal Cancer Stage, run by Yanqing Li 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 2 inclusion and 4 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 1 Mar 2018. 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.
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 Yanqing Li (18678827666, liyanqing@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The first day of food intake of enrolled patients (time frame: An average of 1week). 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 1 Mar 2018.