Percutaneous Cryoablation Peripheral Lung Cancer (PCPLC)
Primary Purpose
Lung Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Percutaneous cryoablation
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring lung cancer, Percutaneous cryoablation, treatment of medically inoperable
Eligibility Criteria
Inclusion Criteria:
medically inoperable peripheral lung cancer Diameter no more than 3cm
Exclusion Criteria:
- Refusal of participation
- tendency to bleed to that can't receive percutaneous cryoablation.
- Severe cardiopulmonary dysfunction and other indications that can't receive percutaneous cryoablation.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
treatment
Arm Description
Patients who are medically inoperable peripheral lung cancer will enroll in this study.They will receive percutaneous cryoablation and follow-up according to schedule.
Outcomes
Primary Outcome Measures
PFS
Secondary Outcome Measures
OS
Full Information
NCT ID
NCT02665390
First Posted
January 22, 2016
Last Updated
February 10, 2016
Sponsor
Shanghai Chest Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02665390
Brief Title
Percutaneous Cryoablation Peripheral Lung Cancer
Acronym
PCPLC
Official Title
Percutaneous Cryoablation for the Treatment of Medically Inoperable Peripheral Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
January 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Chest Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is focus on percutaneous cryoablation,which was for the treatment of medically inoperable Peripheral lung cancer.The patients who were agreed to attend the study will accept the operation. After the operations,they will follow up according to the plan.
Detailed Description
The patients who were agreed to attend the study conclude early stage lung cancer and solitary metastatic lung cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
lung cancer, Percutaneous cryoablation, treatment of medically inoperable
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment
Arm Type
Experimental
Arm Description
Patients who are medically inoperable peripheral lung cancer will enroll in this study.They will receive percutaneous cryoablation and follow-up according to schedule.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous cryoablation
Intervention Description
Percutaneous cryoablation
Primary Outcome Measure Information:
Title
PFS
Time Frame
2 years
Secondary Outcome Measure Information:
Title
OS
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
medically inoperable peripheral lung cancer Diameter no more than 3cm
Exclusion Criteria:
Refusal of participation
tendency to bleed to that can't receive percutaneous cryoablation.
Severe cardiopulmonary dysfunction and other indications that can't receive percutaneous cryoablation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sun jiayuan, MD
Phone
18017321598
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sun jiayuan, MD
Organizational Affiliation
Shanghai Chest Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22626572
Citation
Zhang X, Tian J, Zhao L, Wu B, Kacher DS, Ma X, Liu S, Ren C, Xiao YY. CT-guided conformal cryoablation for peripheral NSCLC: initial experience. Eur J Radiol. 2012 Nov;81(11):3354-62. doi: 10.1016/j.ejrad.2012.04.035. Epub 2012 May 23.
Results Reference
background
PubMed Identifier
16678583
Citation
Kawamura M, Izumi Y, Tsukada N, Asakura K, Sugiura H, Yashiro H, Nakano K, Nakatsuka S, Kuribayashi S, Kobayashi K. Percutaneous cryoablation of small pulmonary malignant tumors under computed tomographic guidance with local anesthesia for nonsurgical candidates. J Thorac Cardiovasc Surg. 2006 May;131(5):1007-13. doi: 10.1016/j.jtcvs.2005.12.051.
Results Reference
background
PubMed Identifier
22096520
Citation
Yamauchi Y, Izumi Y, Kawamura M, Nakatsuka S, Yashiro H, Tsukada N, Inoue M, Asakura K, Nomori H. Percutaneous cryoablation of pulmonary metastases from colorectal cancer. PLoS One. 2011;6(11):e27086. doi: 10.1371/journal.pone.0027086. Epub 2011 Nov 9.
Results Reference
background
PubMed Identifier
22413004
Citation
Yamauchi Y, Izumi Y, Hashimoto K, Yashiro H, Inoue M, Nakatsuka S, Goto T, Anraku M, Ohtsuka T, Kohno M, Kawamura M, Nomori H. Percutaneous cryoablation for the treatment of medically inoperable stage I non-small cell lung cancer. PLoS One. 2012;7(3):e33223. doi: 10.1371/journal.pone.0033223. Epub 2012 Mar 8.
Results Reference
result
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Percutaneous Cryoablation Peripheral Lung Cancer
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