Esophageal CancerNCT00826813
Trial Using 125I Embedded Stent in Patients With Advanced Esophageal Cancer
A study testing Esophageal stent placement in people with Esophageal Cancer, run by Southeast University, China at 1 site in China.
Trial summary
More than half of patients with esophageal cancer are inoperable because of late stage cancer or metastasis and they have to undergo palliative treatments. Dysphagia is the major symptom of patients with inoperable esophageal cancer. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Esophageal stent placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- Jan 2009to Mar 2011
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed primary cancer of esophagus,
- Must be dysphagia caused by esophageal cancer,
- Without esophageal fistulas,
- Must be an inpatient,
- Life expectancy is over 6 months
Who cannot join
- Esophageal fistulas,
- Tracheal compression with symptoms,
- WBC <2000/mm3 and Platelet count <50,000/mm3,
- Concurrent therapies after stenting:surgery, chemotherapy,radiotherapy, Traditional Chinese Medicine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IV Study of Self-Expandable Esophageal Stent Loaded With 125I Seeds: a Randomized Controlled Multiple Center Trial in Patients With Advanced Esophageal Cancer
More than half of patients with esophageal cancer are inoperable because of late stage cancer or metastasis and they have to undergo palliative treatments. Dysphagia is the major symptom of patients with inoperable esophageal cancer. To relieve the dysphagia and improve the quality of life of such patients, stent placement has been widely accepted to be an option for palliation of the symptoms. However, recurrence of the neoplastic stricture remains a challenge after stent placement. To combine the advantages of the immediate relief of the esophageal dysphagia with the stent placement and radiation therapy with brachytherapy, a novel esophageal stent loaded with 125I seeds has been developed in the authors' institute. The preliminary clinical trial in a single institute has demonstrated better results than the conventional stent. This prospective multiple center trial is designed to further demonstrate the clinical outcomes with this irradiation, stent in patients compared to those using a conventional covered stent.
Read the detailed description
Esophageal cancer ranks as the fourth leading cause of death from cancer in China and sixth worldwide. Although the prognosis of surgical resection for esophageal cancer has been improved, more than 50% of such patients are inoperable and have to undergo palliative treatments because of late stage cancer or metastasis. Dysphagia is the predominate symptom of patients with inoperable esophageal cancer. To relieve the dysphagia and improve the quality of life of such patients, brachytherapy has previously been utilized. Recently, stent placement has been widely accepted to be an option for palliation of the symptoms due to the esophageal strictures. However, recurrence of the neoplastic stricture remains a challenge after stent placement. To combine the advantages of the immediate relief of the esophageal dysphagia with the stent placement and radiation therapy with brachytherapy, a novel esophageal stent loaded with 125I seeds has been developed in the authors' institute. The technical feasibility and safety with this new stent has been demonstrated to be adequate in a healthy rabbit model. The following preliminary clinical study in a single institute has demonstrated longer survival time, better quality of life and less restenosis of the stent than whose with the conventional stent. This prospective multiple center trial is designed to further demonstrate the clinical outcomes with this irradiation, stent in patients compared to those using a conventional covered stent.
- Conditions
- Esophageal Cancer
- Being tested
- Esophageal stent placement
- Keywords
- Dysphagia, esophageal cancer, stent, brachytherapy
- Medical subject headings
- Esophageal Neoplasms, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal stent placementDevice
Also called esophageal stent implantation
The esophageal stent combined a self-expandable covered esophageal stent and 125I radioactive seeds. Sheathes were attached to the outer surface of the stent, containing 125I radioactive seeds of CIAE 6711. The seeds were loaded into the sheathes on the stent immediately before implantation of the stent. The numbers and dose of the radioactive stent seeds was determined by the treatment plan system based on the size of the individual tumor. To cover the entire lesion of the tumor by the sheaths containing 125I seeds, at least 2 cm exceeding the tumor margins was required. The distance between the two sheaths was 15mm. In the control group, conventional covered esophageal stents were used which provided by the same company as those attached with 125I seeds.
| Study group | Role | What they receive |
|---|---|---|
| stenting | Experimental | The conventional esophageal stent or 125I radiation stent is placed in the patients with dysphagia who are enrolled to the study. Receives: Device: Esophageal stent placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: Death of the patient
Secondary outcomes (3)
Quality of life
Measured: 3, 6, 12 months
Restenosis of the stent
Measured: 3, 6, 12 months
Dysphagia relief
Measured: 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionMar 2010 (estimated)
- Study completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Esophageal 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Investigators
- Gao-Jun Teng, MD, Ph.D, Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00826813
- Sponsor's protocol ID
- 2009A123456
- Other IDs
- H200343
- Status last verified
- Jan 2009
- First submitted
- 21 Jan 2009
- Last updated
- 22 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Guo JH, Teng GJ, Zhu GY, He SC, Fang W, Deng G, Li GZ. Self-expandable esophageal stent loaded with 125I seeds: initial experience in patients with advanced esophageal cancer. Radiology. 2008 May;247(2):574-81. doi: 10.1148/radiol.2472070999. Epub 2008 Mar 18.
PubMed 18349316Guo JH, Teng GJ, Zhu GY, He SC, Deng G, He J. Self-expandable stent loaded with 125I seeds: feasibility and safety in a rabbit model. Eur J Radiol. 2007 Feb;61(2):356-61. doi: 10.1016/j.ejrad.2006.10.003. Epub 2006 Nov 7.
PubMed 17085003
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of Self-Expandable Esophageal Stent Loaded With 125I Seeds: a Randomized Controlled Multiple Center Trial in Patients With Advanced Esophageal Cancer
- ClinicalTrials.gov ID
- NCT00826813
- Acronym / sponsor ID
- 2009A123456
- Conditions
- Esophageal Cancer
- Keywords
- Dysphagia, esophageal cancer, stent, brachytherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 22 Jan 2009 (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.
More than half of patients with esophageal cancer are inoperable because of late stage cancer or metastasis and they have to undergo palliative treatments. Dysphagia is the major symptom of patients with inoperable esophageal cancer. To relieve the dysphagia and improve the quality of life of such patients, stent placement has been widely accepted to be an option for palliation of the symptoms. However, recurrence of the neoplastic stricture remains a challenge after stent placement. To combine the advantages of the immediate relief of the esophageal dysphagia with the stent placement and radiation therapy with brachytherapy, a novel esophageal stent loaded with 125I seeds has been developed in the authors' institute. The preliminary clinical trial in a single institute has demonstrated better results than the conventional stent. This prospective multiple center trial is designed to further demonstrate the clinical outcomes with this irradiation, stent in patients compared to those using a conventional covered stent.
Detailed description
Esophageal cancer ranks as the fourth leading cause of death from cancer in China and sixth worldwide. Although the prognosis of surgical resection for esophageal cancer has been improved, more than 50% of such patients are inoperable and have to undergo palliative treatments because of late stage cancer or metastasis. Dysphagia is the predominate symptom of patients with inoperable esophageal cancer. To relieve the dysphagia and improve the quality of life of such patients, brachytherapy has previously been utilized. Recently, stent placement has been widely accepted to be an option for palliation of the symptoms due to the esophageal strictures. However, recurrence of the neoplastic stricture remains a challenge after stent placement. To combine the advantages of the immediate relief of the esophageal dysphagia with the stent placement and radiation therapy with brachytherapy, a novel esophageal stent loaded with 125I seeds has been developed in the authors' institute. The technical feasibility and safety with this new stent has been demonstrated to be adequate in a healthy rabbit model. The following preliminary clinical study in a single institute has demonstrated longer survival time, better quality of life and less restenosis of the stent than whose with the conventional stent. This prospective multiple center trial is designed to further demonstrate the clinical outcomes with this irradiation, stent in patients compared to those using a conventional covered stent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stenting | Experimental | Device: Esophageal stent placementThe conventional esophageal stent or 125I radiation stent is placed in the patients with dysphagia who are enrolled to the study. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed primary cancer of esophagus,
- Must be dysphagia caused by esophageal cancer,
- Without esophageal fistulas,
- Must be an inpatient,
- Life expectancy is over 6 months
Key exclusion criteria (4 listed)
- Esophageal fistulas,
- Tracheal compression with symptoms,
- WBC <2000/mm3 and Platelet count <50,000/mm3,
- Concurrent therapies after stenting:surgery, chemotherapy,radiotherapy, Traditional Chinese Medicine
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 |
|---|---|---|
| Esophageal stent placementAlso: esophageal stent implantationThe esophageal stent combined a self-expandable covered esophageal stent and 125I radioactive seeds. Sheathes were attached to the outer surface of the stent, containing 125I radioactive seeds of CIAE 6711. The seeds were loaded into the sheathes on the stent immediately before implantation of the stent. The numbers and dose of the radioactive stent seeds was determined by the treatment plan system based on the size of the individual tumor. To cover the entire lesion of the tumor by the sheaths containing 125I seeds, at least 2 cm exceeding the tumor margins was required. The distance between the two sheaths was 15mm. In the control group, conventional covered esophageal stents were used which provided by the same company as those attached with 125I seeds. | Device | stenting |
Primary outcome
Overall survival
Time frame: Death of the patient
3 secondary outcomes
Quality of life
Time frame: 3, 6, 12 months
Restenosis of the stent
Time frame: 3, 6, 12 months
Dysphagia relief
Time frame: 3, 6, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2009.
- Background: PubMed 18349316Guo JH, Teng GJ, Zhu GY, He SC, Fang W, Deng G, Li GZ. Self-expandable esophageal stent loaded with 125I seeds: initial experience in patients with advanced esophageal cancer. Radiology. 2008 May;247(2):574-81. doi: 10.1148/radiol.2472070999. Epub 2008 Mar 18.
- Background: PubMed 17085003Guo JH, Teng GJ, Zhu GY, He SC, Deng G, He J. Self-expandable stent loaded with 125I seeds: feasibility and safety in a rabbit model. Eur J Radiol. 2007 Feb;61(2):356-61. doi: 10.1016/j.ejrad.2006.10.003. Epub 2006 Nov 7.
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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.
Gao-Jun Teng, MD, Ph.D principal investigator
Zhongda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esophageal stent placement in people with Esophageal Cancer, run by Southeast University, China 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 5 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 22 Jan 2009. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Death of the patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00826813, which also lists 2 linked publications.
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 22 Jan 2009.