NCT02665390

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable lung-cancer

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable lung-cancer

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

February 12, 2016

Status Verified

February 1, 2016

Enrollment Period

1.9 years

First QC Date

January 22, 2016

Last Update Submit

February 10, 2016

Conditions

Lung Cancer

Keywords

lung cancerPercutaneous cryoablationtreatment of medically inoperable

Outcome Measures

Primary Outcomes (1)

  • PFS

    2 years

Secondary Outcomes (1)

  • OS

    2 years

Study Arms (1)

treatment

EXPERIMENTAL

Patients who are medically inoperable peripheral lung cancer will enroll in this study.They will receive percutaneous cryoablation and follow-up according to schedule.

Procedure: Percutaneous cryoablation

Interventions

Percutaneous cryoablationPROCEDURE

Percutaneous cryoablation

treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • medically inoperable peripheral lung cancer Diameter no more than 3cm

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 22626572BACKGROUND

  • 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.

    PMID: 16678583BACKGROUND

  • 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.

    PMID: 22096520BACKGROUND

  • 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.

    PMID: 22413004RESULT

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Sun jiayuan, MD

    Shanghai Chest Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sun jiayuan, MD

CONTACT

18017321598

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Endoscope Center, Shanghai Chest Hospita

Study Record Dates

First Submitted

January 22, 2016

First Posted

January 27, 2016

Study Start

February 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2020

Last Updated

February 12, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share