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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

A Metal Bare Stent With 125 Iodine (125I)Seeds for the Treatment of Malignant Central Airway Stenosis

Clinicaltrials.gov identifier NCT03944408

Recruitment Status Not yet recruiting

First Posted May 9, 2019

Last update posted May 9, 2019

Study Description

Brief summary:

Malignant central airway stenosis caused by primary or metastatic malignant tumor may lead to dyspnea even death of patients.With the rapid development of interventional pulmonology, bronchoscopic therapy has become the main treatment for malignant central airway stenosis. Metal stent implantation in airway can quickly relieve respiratory obstruction and improve quality of life.However, the tumor tissue can continue to grow into metal stent and obstruct airway again. This is the shortcoming of metal bare stents, which often need further treatment to keep airway open, including ablation, laser, cryotherapy, external radiotherapy or systemic anti-tumor drug therapy.Metal stent implantation combined with external radiotherapy can effectively reduce the incidence of airway restenosis.However, complications of external radiotherapy are high, including bone marrow suppression, radioactive pneumonia, radioactive esophagitis, myocardial injury and tracheoesophageal fistula, of which may cause serious consequences and even cause death of the patient.125I radioactive seeds have been one of the mature radioactive interventional therapy, which release X rays, and γ rays. Because of the short radioactive distance, 125I seeds can destruct tumor cells in tumor site and promote apoptosis and necrosis of tumor cells around the obstruction of the airway, meanwhile cause little damage to the surrounding normal tissues. Some studies showed that 125I seed implantation of lung tumor lesions achieved good short-term results.Therefore, the investigators hypothesize that 125I seeds fixed on the metal bare stent can not only improve the patient's breathing difficulties, but also play a role in killing tumor cells. At present, there have been reports of related clinical cases and monocentric control studies of malignant central airway stenosis treated with the implantation of metal stent with 125I seeds, but there is a lack of multicentric clinical studies with large samples.

  • Condition or Disease:Malignant Airway Obstruction
  • Intervention/Treatment: Procedure: stent implantation
  • Phase: N/A
Detailed Description

It is an open, multicentric randomized controlled clinical trial conducted in China, and plan to recruiting 200 patients who suffer malignant central airway stenosis. To evaluate the efficacy and safety of metal stent with 125I seeds group and metal bare stent group in the treatment of malignant central airway stenosis, follow-up should be done within 1 week, 1 month, and 3 months after the first treatment, followed by every 3 months. The contents include review of bronchoscopy and chest CT, blood routine, immune indicators (IgA, immunoglobulin M(Ig M), IgG), evaluation of general conditions. The patients of the first group need emission-computed tomography(ECT) imaging or positron emission tomography-computed tomography (PET-CT) examination within 1 month. If the patient has severe dyspnea, emergency bronchoscopy should be performed .

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 200 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: The Efficacy and Safety of a Metal Bare Stent With 125I Seeds for the Treatment of Malignant Central Airway Compared to a Metal Bare Stent: A Multicentric Randomized Controlled Study.
  • Estimated Study Start Date: May 2019
  • Estimated Primary Completion Date: July 2021
  • Estimated Study Completion Date: February 2022
Arms and interventions
Arm Intervention/treatment
Other: A metal bare stent
A metal bare stent implantation
Procedure: stent implantation
stent implantation
Experimental: A metal bare stent with 125I seeds
125I seeds fixed on the metal bare stent, then stent implantation
Procedure: stent implantation
stent implantation
Outcome Measures
  • Primary Outcome Measures: 1. stenosis grade [ Time Frame: the first month after stent implantation ]
    Stenosis grade was classified as 5 grades on the cross-sectional CT imaging area: grade 0 = non-appreciable stenosis; grade 1, 2, 3, and 4 = 25, 50, 75, and 90% decrease in area, respectively; grade 5 = complete obstruction
  • 2. stenosis grade [ Time Frame: the third month after stent implantation ]
    Stenosis grade was classified as 5 grades on the cross-sectional CT imaging area: grade 0 = non-appreciable stenosis; grade 1, 2, 3, and 4 = 25, 50, 75, and 90% decrease in area, respectively; grade 5 = complete obstruction
  • Secondary Outcome Measures: 1. overall survival (OS) [ Time Frame: From randomization until death (up to 24 months) ]
    overall survival
  • 2. technical success [ Time Frame: one week after stent implantation ]
    successful implantation of the stent across the stricture with appropriate positioning of the stent and full expansion
  • 3. complications and side effects [ Time Frame: From randomization until death (up to 24 months) ]
    Possible radiation related complications included neutropenia, decrease in IgA, IgG, and IgM, and leakage of radioactive seeds.Neutropenia was defined as a total white blood cell count b4000/mm3 in the plasma. The leakage of radioactive seeds was defined as the detection of non-target radioactive source verified by radiography
  • 4. tumor growth rate [ Time Frame: From randomization until death (up to 24 months) ]
    the size of tumor assessed by CT after stent implantation
  • 5. the time of emergency endoscopic treatment [ Time Frame: From randomization until death (up to 24 months) ]
    record the time of emergency endoscopic treatment for the recurrent severe dyspnea of patient
Eligibility Criteria
  • Ages Eligible for Study: 18 to 75 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

1. Age range: 18-75 years old, male or female who is not pregnant

2. Comply with the diagnosis of malignant central airway stenosis, and undergo chest CT
or bronchoscopy to confirm that the stenosis degree is above 50% and need to be
implanted with airway metal stent; or the patient has obvious dyspnea due to airway
stenosis, obstructive pneumonia

3. Subjects voluntarily joined the study and signed informed consent, with good
compliance and follow-up.

4. Unable or refused surgery

5. Unable or refused external radiation therapy

6. Unable or refuse systemic tumor-related drugs therapy within 3 months

Exclusion Criteria:

1. The distal end of the stenosis is unpredictable, and the stent treatment may not be
satisfactory;

2. Severe arrhythmia, acute myocardial ischemia, uncontrollable hypertensive crisis;

3. Severe coagulopathy

4. Severe organ dysfunction (except respiratory insufficiency)

5. Allergic to anesthetics

6. Airway fistula lesions

7. The narrow lesion involves 2cm inside the glottis

8. History of extrathoracic radiation therapy in the past 6 months

9. Severe myelosuppression

Contacts and Locations
Contacts

Contact: Chengshui Chen, doctor 86 13806889081 ext 8613806889081 wzchencs@163.com

Contact: Xiaoxiao Lin, doctor 8615068252060 ext 8615068252060 295357950@qq.com

Locations

China, Zhejiang
The first affiliated hospital of wenzhou medical university
Wenzhou

Sponsors and Collaborators

First Affiliated Hospital of Wenzhou Medical University

Shanghai 10th People's Hospital

The Second Affiliated Hospital of Xiamen Medical College

Anhui Chest Hospital

China Meitan General Hospital

The Second Hospital of Hebei Medical University

West China Hospital

The Second Affiliated Hospital of Fujian Medical University

The Central Hospital of Wuhan

Wuhan No.1 Hospital

Hunan People's Hospital

First Affiliated Hospital of Chongqing Medical University

Yichang Central People's Hospital

Investigators

Study Chair: Chengshui Chen, doctor First Affiliated Hospital of Wenzhou Medical University

More Information