Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer

Intrahepatic Cholangiocarcinoma Clinical Trial

Official title:

Intraluminal Implantation of Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02238613
• Other study ID #: yanliu307
• Secondary ID: 307xhk
• Status: Recruiting
• Phase: N/A
• First received: August 25, 2014
• Last updated: September 10, 2014
• Start date: August 2014
• Est. completion date: June 2017

Study information

• Verified date: September 2014
• Source: 307 Hospital of PLA
• Contact: Yan Liu, MD,PhD
• Phone: 86-13911798288
• Email: 13911798288[@]163.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether radioactive stents and common used plastic stents are effective and safety in the treatment of unresectable biliary tract cancer.

Description:

Patients with unresectable biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma, or ampullary carcinoma) were enrolled and placed with a stent loaded with radioactive seeds (irradiation stent group) or a conventional plastic stent (traditional stent group). After stent placement, the outcomes were compared in terms of tumor response, progression-free survival, overall survival time, and complications related to the procedures.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: June 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients were eligible if they had received a histopathological or cytologic diagnosis of nonresectable, recurrent, or metastatic biliary tract carcinoma (intrahepatic or extrahepatic cholangiocarcinoma,or ampullary carcinoma)

• Patients aged between 18 and 80 years

• an estimated life expectancy of more than 3 months

• Disease had to be measurable by computed tomography scan (as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria

• TNM stage III-IV

• no evidence of cancer of another organ.

• no prior chemotherapy for advanced disease was allowed, but adjuvant/neoadjuvant therapy was allowed

• Karnofsky index of =60%

• ECOG index =2

• previous technically successful stenting or ENBD derange

• Accept of informed consent

Exclusion Criteria:

• Clinically significant cardiovascular disease

• coagulation disorders

• contraindication of Endoscopic

• pregnant or breastfeeding women

• known sensitivity sensitivity to investigated agents or components

• recent invasive procedure

• prior chemotherapy or radiotherapy for biliary cancer

• refusal of informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ampullary Carcinoma
• Biliary Obstruction
• Cholangiocarcinoma
• Cholangiocarcinoma of the Extrahepatic Bile Duct
• Intrahepatic Cholangiocarcinoma
• Liver Neoplasms

Intervention

Device:
• radioactive stent
radioactive stent carrying seed iodine 125
• plastic stent
common plastic stent without carrying seed iodine 125

Locations

Country	Name	City	State
China	307 hospital of PLA	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
307 Hospital of PLA	Changhai Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor Response rate	The investigators will conduct CT test or MRI scan after the implantation of the stents in order to measure the tumor size of each patients and evaluate the best tumor response according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.0).	3 months	Yes
Secondary	Progression-free survival	In order to research the progression-free survival, the investigators will check the presence of progression disease for each patients until the date of disease progression or death.	6 months	Yes
Secondary	overall survival	Overall survival was calculated from the date of randomization until the date of death.	follow-up in interval of stent insertion and death (1 years)	Yes
Secondary	Adverse events	Individual adverse events	1 year	Yes