Lung CancerPCPLCNCT02665390
Percutaneous Cryoablation Peripheral Lung Cancer
A study testing Percutaneous cryoablation in people with Lung Cancer, run by Shanghai Chest Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Percutaneous cryoablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- medically inoperable peripheral lung cancer Diameter no more than 3cm
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
Sun jiayuan, MD contact
About this study
Official title: Percutaneous Cryoablation for the Treatment of Medically Inoperable Peripheral Lung Cancer
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.
Read the detailed description
The patients who were agreed to attend the study conclude early stage lung cancer and solitary metastatic lung cancer.
- Conditions
- Lung Cancer
- Being tested
- Percutaneous cryoablation
- Keywords
- lung cancer, Percutaneous cryoablation, treatment of medically inoperable
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous cryoablationProcedure or surgery
Percutaneous cryoablation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Percutaneous cryoablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Measured: 2 years
Secondary outcomes (1)
OS
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionJan 2018 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiayuan Sun, Shanghai Chest Hospital
- Investigators
- Sun jiayuan, MD, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02665390
- Sponsor's protocol ID
- SHCHE201601
- Acronym
- PCPLC
- Status last verified
- Feb 2016
- First submitted
- 22 Jan 2016
- Last updated
- 12 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 22626572Kawamura 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.
PubMed 16678583Yamauchi 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.
PubMed 22096520Yamauchi 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.
PubMed 22413004
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Cryoablation for the Treatment of Medically Inoperable Peripheral Lung Cancer
- ClinicalTrials.gov ID
- NCT02665390
- Acronym / sponsor ID
- PCPLC / SHCHE201601
- Conditions
- Lung Cancer
- Keywords
- lung cancer, Percutaneous cryoablation, treatment of medically inoperable
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 27 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Procedure: Percutaneous cryoablationPatients who are medically inoperable peripheral lung cancer will enroll in this study.They will receive percutaneous cryoablation and follow-up according to schedule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- medically inoperable peripheral lung cancer Diameter no more than 3cm
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous cryoablationPercutaneous cryoablation | Procedure or surgery | treatment |
Primary outcome
PFS
Time frame: 2 years
1 secondary outcome
OS
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2016.
- Background: PubMed 22626572Zhang 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.
- Background: PubMed 16678583Kawamura 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.
- Background: PubMed 22096520Yamauchi 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 publication: PubMed 22413004Yamauchi 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.
- Individual participant dataSharing planned: No
Related trials for Lung Cancer
RecruitingPhase 3
A Study Comparing TAK-928 With Docetaxel in Adults With Non-Small Cell Lung Cancer
IO Resistant Squamous and Nonsquamous NSCLC
RecruitingPhase 3
MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013)
Non-small Cell Lung Cancer
RecruitingPhase 2
A Study of Navlimetostat (BMS-986504) Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)
Solid Tumors
Not yet recruitingPhase 1
A Phase 1 Trial of KAN-001 With Pembrolizumab, With or Without Chemotherapy, in Participants With PD-L1-Positive Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer
Active, not recruitingPhase 1/2
RNA Lipid Particles Targeting Pediatric Recurrent Intracranial Malignancies and Other systEmic Solid Tumors
Recurrent Pulmonary Osteosarcoma, Recurrent High-grade Glioma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sun jiayuan, MD contact
Sun jiayuan, MD principal investigator
Shanghai Chest Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous cryoablation in people with Lung Cancer, run by Shanghai Chest Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sun jiayuan, MD (18017321598), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02665390, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2016.