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Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer

Primary Purpose

Intrahepatic Cholangiocarcinoma, Cholangiocarcinoma of the Extrahepatic Bile Duct, Ampullary Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
radioactive stent
plastic stent
Sponsored by
307 Hospital of PLA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intrahepatic Cholangiocarcinoma focused on measuring Radioactive stents, Brachytherapy, Biliary obstruction, Intrahepatic Cholangiocarcinoma, Cholangiocarcinoma of the Extrahepatic Bile Duct, ampullary carcinoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 307 hospital of PLARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

radioactive stent

plastic stent

Arm Description

The radioactive stent carrying seeds iodine 125 is made of Polytetrafluoroethylene. It will be implanted in the common bile duct by ERCP(endoscopic retrograde cholangiopancreatography) of the irradiation group patients.

The plastic stent is made of polyethylene. It will be implanted in the common bile duct by ERCP(endoscopic retrograde cholangiopancreatography) of the conventional group patients.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
overall survival
Overall survival was calculated from the date of randomization until the date of death.
Adverse events
Individual adverse events

Full Information

First Posted
August 25, 2014
Last Updated
September 10, 2014
Sponsor
307 Hospital of PLA
Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Changhai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02238613
Brief Title
Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer
Official Title
Intraluminal Implantation of Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
307 Hospital of PLA
Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Changhai Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrahepatic Cholangiocarcinoma, Cholangiocarcinoma of the Extrahepatic Bile Duct, Ampullary Carcinoma, Biliary Obstruction
Keywords
Radioactive stents, Brachytherapy, Biliary obstruction, Intrahepatic Cholangiocarcinoma, Cholangiocarcinoma of the Extrahepatic Bile Duct, ampullary carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
radioactive stent
Arm Type
Experimental
Arm Description
The radioactive stent carrying seeds iodine 125 is made of Polytetrafluoroethylene. It will be implanted in the common bile duct by ERCP(endoscopic retrograde cholangiopancreatography) of the irradiation group patients.
Arm Title
plastic stent
Arm Type
Other
Arm Description
The plastic stent is made of polyethylene. It will be implanted in the common bile duct by ERCP(endoscopic retrograde cholangiopancreatography) of the conventional group patients.
Intervention Type
Device
Intervention Name(s)
radioactive stent
Other Intervention Name(s)
brand names: carriable radioactive bile duct plastic stent, serial numbers and code name: PBS1-A/B-10/160/140
Intervention Description
radioactive stent carrying seed iodine 125
Intervention Type
Device
Intervention Name(s)
plastic stent
Intervention Description
common plastic stent without carrying seed iodine 125
Primary Outcome Measure Information:
Title
Tumor Response rate
Description
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).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
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.
Time Frame
6 months
Title
overall survival
Description
Overall survival was calculated from the date of randomization until the date of death.
Time Frame
follow-up in interval of stent insertion and death (1 years)
Title
Adverse events
Description
Individual adverse events
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Liu, MD,PhD
Phone
86-13911798288
Email
13911798288@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Liu, Doctor
Organizational Affiliation
307 hospital of PLA, Beijing, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
307 hospital of PLA
City
Beijing
State/Province
Beijing
ZIP/Postal Code
10086
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhaoshen Li, Doctor
First Name & Middle Initial & Last Name & Degree
Min Min, M.D. PhD.

12. IPD Sharing Statement

Learn more about this trial

Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer

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