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

Progression Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04905056
• Other study ID #: B2021-088R
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2021
• Est. completion date: December 31, 2028

Study information

• Verified date: May 2021
• Source: Shanghai Zhongshan Hospital
• Contact: Qun Wang, Phd
• Phone: 86-21-64041990
• Email: 13301050210[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Aged between 18 and 85 years;

2. GGO is diagnosed by lung CT and failure to subside after 3 months (the patient having been re-examined by thin-section CT);

3. The maximum diameter of the GGO is bigger than 8mm and smaller than 3cm;

4. 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

5. 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

6. The patient is able to understand and comply with the study and has provided written informed consent

Exclusion Criteria:

1. Patients who participated in any drug and / or medical device clinical trials within one month before the trial

2. had severe disease conditions

3. allergy to narcotic drugs

4. had other autoimmune disease

5. dementia or cognitive impairment can't cooperate with researchers

6. any local treatment other than ablation was received within 4 weeks before the study

Related Conditions & MeSH terms

• Disease Progression
• Progression

Intervention

Other:
• Ablation therapy
Ablation therapy in the treatment of lung cancer presenting as ground-glass nodules

Locations

Country	Name	City	State
China	Department of Thoracic Surgery, Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival	One year progression free survival after radiofrequency ablation of ground glass nodules	1 years
Secondary	overall survival	overall survival after radiofrequency ablation of ground glass nodules	1 years, 3 years, 5years