Malignant Airway ObstructionPhase 2NCT02565927
A Trail of a Novel Tracheal Radioactive Stent for the Malignant Airway Obstruction
A Phase 2 study testing Traditional airway stent and Iodine-125 seeds in people with Malignant Airway Obstruction, run by Zhongda Hospital at 1 site in China.
Trial summary
The aim of this study was to evaluate the safety and effectiveness of an radioactive airway stent loaded with 125I seeds compared to a conventional airway stent in patients with malignant airway obstruction caused by both primary and metastatic malignant tumors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Malignant Airway Obstruction
- What is being tested?
- Traditional airway stent and Iodine-125 seeds
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- May 2015to Sep 2016
- Phase
- Phase 2
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged between 18 and 80 years
- MAO caused by any adenocarcinoma with histologically or cytologically confirmation by biopsy or previous surgical procedures
- symptoms such as dyspnea related to biliary obstruction
- unresectability or refusal to be surgically treated
- willing and able to comply with the study procedures and provide written informed consent to participate
Who cannot join
- patients with suspected benign airway obstruction
- airway obstruction that could not be dilated enough to pass the delivery system
- perforation of any ducts within the tracheal tree
- presence of metallic tracheal stent or airway surgery
- acute or chronic inflammation in the airway
- uncooperative or could not provide authorization and signature.
Trial locations and contacts
1 site in 1 country.
Yong Wang, Ph.D contact
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital,Southeast University
Nanjing, Jiangsu, 210009
Yong Wang, Ph.D
About this study
Official title: A Novel Tracheal Radioactive Stent Loaded With 125I Seeds for the Malignant Airway Obstruction Versus a Conventional Stent: A Prospective Randomized Controlled Trial
The aim of this study was to evaluate the safety and effectiveness of an radioactive airway stent loaded with 125I seeds compared to a conventional airway stent in patients with malignant airway obstruction caused by both primary and metastatic malignant tumors.
Read the detailed description
Malignant tumors of the lung, esophagus, thyroid, or other mediastinal structures often involve the trachea by direct tumor growth compression and (or) invasion. In addition, extrathoracic cancers metastasize to these lymph nodes as well. However, surgical resection and airway reconstruction are the gold-standard treatment for MAO, many patients with airway involvement are poor surgical candidates based on physiologic or oncologic criteria.There are three main types of malignant airway obstruction: endobronchial obstruction, extrinsic compression, and a mixed pattern. For endobronchial obstruction, ablative techniques that destroy tissue are indicated, including lasers, electrocautery, argon plasma coagulation (APC), photodynamic therapy, microdebriders, and cryotherapy, but primary tracheal cancers are less common than other types of lung cancer. If the obstruction is exclusively or mainly due to compression from outside the airway wall, the only option consists of placement of a stent or endoprosthesis. However, follow-up data has demonstrated that postoperative restenosis of stenting occurs in 5-45% of cases as a result of neoplastic infiltration through the mesh into the lumen or tumor overgrowth above and below the mesh stents. Encouraged by the success of 125I esophageal and biliary stent in esophageal carcinoma , a tracheal stent loaded with 125I radioactive seeds was developed in investigators'institute. After successful in vitro and in vivo evaluations of the delivery system, investigator will prospectively compare responses to treatment with this irradiation tracheal stent versus the conventional self-expandable stent in patients with MAO.
- Conditions
- Malignant Airway Obstruction
- Being tested
- Traditional airway stent, Iodine-125 seeds
- Keywords
- Trachea, Stent, Intraluminal brachytherapy
- Medical subject headings
- Tracheal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional airway stentDevice
Also called Tracheal stent(Nanjing MicroInvasive Medical Inc.)
process airway stenting
Iodine-125 seedsDrug
Also called Radioactive seeds(Chinese Atomic Energy Science Institution)
process intraluminal brachytherapy
| Study group | Role | What they receive |
|---|---|---|
| Radioactive stent | Experimental | Patients diagnosed as MAO treated with radioactive airway stent loaded with Iodine-125 seeds Receives: Device: Traditional airway stent; Drug: Iodine-125 seeds |
| Traditional airway stent | Active comparator | Patients diagnosed as MAO treated with traditional airway stent Receives: Device: Traditional airway stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
diameter stenosis
reference tracheal diameter minus minimum diameter at stenosis site / reference tracheal diameter×100
Measured: Participants will be followed till die or lost to follow-up,an expected average of a year.
Secondary outcomes (1)
Over survival
Time from stenting to the day when the patients died or lost to the follow-up.
Measured: Participants will be followed till die or lost to follow-up,an expected average of a year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startMay 2015
- Primary completionAug 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Airway ObstructionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao-jun Teng, Zhongda Hospital
- Investigators
- Gao-jun Teng, Ph.D,MD, Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565927
- Sponsor's protocol ID
- 2015ZDSYLL032.0
- Status last verified
- Sep 2015
- First submitted
- 20 Sep 2015
- Last updated
- 1 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Tracheal Radioactive Stent Loaded With 125I Seeds for the Malignant Airway Obstruction Versus a Conventional Stent: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02565927
- Acronym / sponsor ID
- 2015ZDSYLL032.0
- Conditions
- Malignant Airway Obstruction
- Keywords
- Trachea, Stent, Intraluminal brachytherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 1 Oct 2015 (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.
The aim of this study was to evaluate the safety and effectiveness of an radioactive airway stent loaded with 125I seeds compared to a conventional airway stent in patients with malignant airway obstruction caused by both primary and metastatic malignant tumors.
Detailed description
Malignant tumors of the lung, esophagus, thyroid, or other mediastinal structures often involve the trachea by direct tumor growth compression and (or) invasion. In addition, extrathoracic cancers metastasize to these lymph nodes as well. However, surgical resection and airway reconstruction are the gold-standard treatment for MAO, many patients with airway involvement are poor surgical candidates based on physiologic or oncologic criteria.There are three main types of malignant airway obstruction: endobronchial obstruction, extrinsic compression, and a mixed pattern. For endobronchial obstruction, ablative techniques that destroy tissue are indicated, including lasers, electrocautery, argon plasma coagulation (APC), photodynamic therapy, microdebriders, and cryotherapy, but primary tracheal cancers are less common than other types of lung cancer. If the obstruction is exclusively or mainly due to compression from outside the airway wall, the only option consists of placement of a stent or endoprosthesis. However, follow-up data has demonstrated that postoperative restenosis of stenting occurs in 5-45% of cases as a result of neoplastic infiltration through the mesh into the lumen or tumor overgrowth above and below the mesh stents. Encouraged by the success of 125I esophageal and biliary stent in esophageal carcinoma , a tracheal stent loaded with 125I radioactive seeds was developed in investigators'institute. After successful in vitro and in vivo evaluations of the delivery system, investigator will prospectively compare responses to treatment with this irradiation tracheal stent versus the conventional self-expandable stent in patients with MAO.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radioactive stent | Experimental | Device: Traditional airway stent, Drug: Iodine-125 seedsPatients diagnosed as MAO treated with radioactive airway stent loaded with Iodine-125 seeds |
| Traditional airway stent | Active comparator | Device: Traditional airway stentPatients diagnosed as MAO treated with traditional airway stent |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged between 18 and 80 years
- MAO caused by any adenocarcinoma with histologically or cytologically confirmation by biopsy or previous surgical procedures
- symptoms such as dyspnea related to biliary obstruction
- unresectability or refusal to be surgically treated
- willing and able to comply with the study procedures and provide written informed consent to participate
Key exclusion criteria (6 listed)
- patients with suspected benign airway obstruction
- airway obstruction that could not be dilated enough to pass the delivery system
- perforation of any ducts within the tracheal tree
- presence of metallic tracheal stent or airway surgery
- acute or chronic inflammation in the airway
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 |
|---|---|---|
| Traditional airway stentAlso: Tracheal stent(Nanjing MicroInvasive Medical Inc.)process airway stenting | Device | Radioactive stent, Traditional airway stent |
| Iodine-125 seedsAlso: Radioactive seeds(Chinese Atomic Energy Science Institution)process intraluminal brachytherapy | Drug | Radioactive stent |
Primary outcome
diameter stenosis
Time frame: Participants will be followed till die or lost to follow-up,an expected average of a year.
reference tracheal diameter minus minimum diameter at stenosis site / reference tracheal diameter×100
1 secondary outcome
Over survival
Time frame: Participants will be followed till die or lost to follow-up,an expected average of a year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2015.
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Malignant Solid Neoplasm
Enrolling by invitationObservational study
Difficult Airway Management in Oncology: An International Delphi Consensus Study (DAMO)
Neoplasms, Airway Obstruction Upper
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.
Yong Wang, Ph.D contact
Gao-jun Teng, Ph.D,MD 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 Phase 2 study testing Traditional airway stent and Iodine-125 seeds in people with Malignant Airway Obstruction, run by Zhongda Hospital 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 6 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 Oct 2015. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yong Wang, Ph.D (medicalusing@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diameter stenosis (time frame: Participants will be followed till die or lost to follow-up,an expected average of a year.). 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 Oct 2015.