Back to resultsA Prospective, Two-center, Single Arm Phase II Clinical Study to Evaluate Safety and Effectiveness of Ablation Therapy in the Treatment of Lung Cancer Presenting as Ground-glass Nodules
Primary Purpose
Progression
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Ablation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Progression
Eligibility Criteria
Inclusion Criteria:
- Aged between 18 and 85 years;
- GGO is diagnosed by lung CT and failure to subside after 3 months (the patient having been re-examined by thin-section CT);
- The maximum diameter of the GGO is bigger than 8mm and smaller than 3cm;
- For single GGO: obvious progress was observed in pure GGO or the solid component of mixed ground glass nodules was more than or equal to 2 mm
- The patients were unable to tolerate the operation for various reasons or multiple grinding glass nodules, operation can not be completely removed; or patients had received surgery in ipsilateral chest
- The patient is able to understand and comply with the study and has provided written informed consent
Exclusion Criteria:
- Patients who participated in any drug and / or medical device clinical trials within one month before the trial
- had severe disease conditions
- allergy to narcotic drugs
- had other autoimmune disease
- dementia or cognitive impairment can't cooperate with researchers
- any local treatment other than ablation was received within 4 weeks before the study
Sites / Locations
- Department of Thoracic Surgery, Zhongshan Hospital, Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ablation therapy in the treatment of lung cancer presenting as ground-glass nodules
Arm Description
Outcomes
Primary Outcome Measures
progression free survival
One year progression free survival after radiofrequency ablation of ground glass nodules
Secondary Outcome Measures
overall survival
overall survival after radiofrequency ablation of ground glass nodules
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04905056
Brief Title
A Prospective, Two-center, Single Arm Phase II Clinical Study to Evaluate Safety and Effectiveness of Ablation Therapy in the Treatment of Lung Cancer Presenting as Ground-glass Nodules
Official Title
A Prospective, Two-center, Single Arm Phase II Clinical Study to Evaluate Safety and Effectiveness of Ablation Therapy in the Treatment of Lung Cancer Presenting as Ground-glass Nodules
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Zhongshan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
A prospective, two-center, single arm phase II clinical study to evaluate safety and effectiveness of ablation therapy in the treatment of lung cancer presenting as ground-glass nodules
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ablation therapy in the treatment of lung cancer presenting as ground-glass nodules
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Ablation therapy
Intervention Description
Ablation therapy in the treatment of lung cancer presenting as ground-glass nodules
Primary Outcome Measure Information:
Title
progression free survival
Description
One year progression free survival after radiofrequency ablation of ground glass nodules
Time Frame
1 years
Secondary Outcome Measure Information:
Title
overall survival
Description
overall survival after radiofrequency ablation of ground glass nodules
Time Frame
1 years, 3 years, 5years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged between 18 and 85 years;
GGO is diagnosed by lung CT and failure to subside after 3 months (the patient having been re-examined by thin-section CT);
The maximum diameter of the GGO is bigger than 8mm and smaller than 3cm;
For single GGO: obvious progress was observed in pure GGO or the solid component of mixed ground glass nodules was more than or equal to 2 mm
The patients were unable to tolerate the operation for various reasons or multiple grinding glass nodules, operation can not be completely removed; or patients had received surgery in ipsilateral chest
The patient is able to understand and comply with the study and has provided written informed consent
Exclusion Criteria:
Patients who participated in any drug and / or medical device clinical trials within one month before the trial
had severe disease conditions
allergy to narcotic drugs
had other autoimmune disease
dementia or cognitive impairment can't cooperate with researchers
any local treatment other than ablation was received within 4 weeks before the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qun Wang, Phd
Phone
86-21-64041990
Email
13301050210@fudan.edu.cn
Facility Information:
Facility Name
Department of Thoracic Surgery, Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qun Wang, phd
Phone
86-21-64041990
Email
13301050210@fudan.edu.cn
12. IPD Sharing Statement
Learn more about this trial
A Prospective, Two-center, Single Arm Phase II Clinical Study to Evaluate Safety and Effectiveness of Ablation Therapy in the Treatment of Lung Cancer Presenting as Ground-glass Nodules
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