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

Malignant Airway Obstruction Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03944408
• Other study ID #: wzchencs
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2019
• Est. completion date: February 2022

Study information

• Verified date: May 2019
• Source: First Affiliated Hospital of Wenzhou Medical University
• Contact: Chengshui Chen, doctor
• Phone: 86 13806889081
• Email: wzchencs[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: February 2022
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Airway Obstruction
• Malignant Airway Obstruction

Intervention

Procedure:
• stent implantation
stent implantation

Locations

Country	Name	City	State
China	The first affiliated hospital of wenzhou medical university	Wenzhou	Zhejiang

Sponsors (13)

Lead Sponsor

Collaborator

First Affiliated Hospital of Wenzhou Medical University

Anhui Chest Hospital, China Meitan General Hospital, First Affiliated Hospital of Chongqing Medical University, Hunan People's Hospital, Shanghai 10th People's Hospital, The Central Hospital of Wuhan, The Second Affiliated Hospital of Fujian Medical University, The Second Affiliated Hospital of Xiamen Medical College, The Second Hospital of Hebei Medical University, West China Hospital, Wuhan No.1 Hospital, Yichang Central People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (12)

Ernst A, Feller-Kopman D, Becker HD, Mehta AC. Central airway obstruction. Am J Respir Crit Care Med. 2004 Jun 15;169(12):1278-97. Review. — View Citation

Lemaire A, Burfeind WR, Toloza E, Balderson S, Petersen RP, Harpole DH Jr, D'Amico TA. Outcomes of tracheobronchial stents in patients with malignant airway disease. Ann Thorac Surg. 2005 Aug;80(2):434-7; discussion 437-8. — View Citation

Lu M, Pu D, Zhang W, Liao J, Zhang T, Yang G, Liu Z, Singh S, Gao F, Zhang F. Trans-bronchoscopy with implantation of (125)I radioactive seeds in patients with pulmonary atelectasis induced by lung cancer. Oncol Lett. 2015 Jul;10(1):216-222. Epub 2015 May — View Citation

Mallick I, Sharma SC, Behera D. Endobronchial brachytherapy for symptom palliation in non-small cell lung cancer--analysis of symptom response, endoscopic improvement and quality of life. Lung Cancer. 2007 Mar;55(3):313-8. Epub 2006 Dec 8. — View Citation

Ong P, Grosu HB, Debiane L, Casal RF, Eapen GA, Jimenez CA, Noor L, Ost DE. Long-term quality-adjusted survival following therapeutic bronchoscopy for malignant central airway obstruction. Thorax. 2019 Feb;74(2):141-156. doi: 10.1136/thoraxjnl-2018-211521 — View Citation

Qu A, Wang H, Li J, Wang J, Liu J, Hou Y, Huang L, Zhao Y. Biological effects of (125)i seeds radiation on A549 lung cancer cells: G2/M arrest and enhanced cell death. Cancer Invest. 2014 Jul;32(6):209-17. doi: 10.3109/07357907.2014.905585. Epub 2014 Apr — View Citation

Rochet N, Hauswald H, Schmaus M, Hensley F, Huber P, Eberhardt R, Herth FJ, Debus J, Neuhof D. Safety and efficacy of thoracic external beam radiotherapy after airway stenting in malignant airway obstruction. Int J Radiat Oncol Biol Phys. 2012 May 1;83(1) — View Citation

Saad CP, Murthy S, Krizmanich G, Mehta AC. Self-expandable metallic airway stents and flexible bronchoscopy: long-term outcomes analysis. Chest. 2003 Nov;124(5):1993-9. — View Citation

Sabath BF, Ost DE. Update on airway stents. Curr Opin Pulm Med. 2018 Jul;24(4):343-349. doi: 10.1097/MCP.0000000000000486. Review. — View Citation

Wang Y, Guo JH, Zhu GY, Zhu HD, Chen L, Lu J, Wang C, Teng GJ. A Novel Self-Expandable, Radioactive Airway Stent Loaded with (125)I Seeds: A Feasibility and Safety Study in Healthy Beagle Dog. Cardiovasc Intervent Radiol. 2017 Jul;40(7):1086-1093. doi: 10 — View Citation

Wang Y, Lu J, Guo JH, Zhu GY, Zhu HD, Chen L, Wang C, Teng GJ. A Novel Tracheobronchial Stent Loaded with (125)I Seeds in Patients with Malignant Airway Obstruction Compared to a Conventional Stent: A Prospective Randomized Controlled Study. EBioMedicine. — View Citation

Wood DE, Liu YH, Vallières E, Karmy-Jones R, Mulligan MS. Airway stenting for malignant and benign tracheobronchial stenosis. Ann Thorac Surg. 2003 Jul;76(1):167-72; discussion 173-4. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stenosis grade	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	the first month after stent implantation
Primary	stenosis grade	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	the third month after stent implantation
Secondary	overall survival (OS)	overall survival	From randomization until death (up to 24 months)
Secondary	technical success	successful implantation of the stent across the stricture with appropriate positioning of the stent and full expansion	one week after stent implantation
Secondary	complications and side effects	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	From randomization until death (up to 24 months)
Secondary	tumor growth rate	the size of tumor assessed by CT after stent implantation	From randomization until death (up to 24 months)
Secondary	the time of emergency endoscopic treatment	record the time of emergency endoscopic treatment for the recurrent severe dyspnea of patient	From randomization until death (up to 24 months)