Back to resultsEfficacy and Safety Study of Medical Thoracoscope Cryotherapy Combined Standard First-line Treatment of Advanced Non-small Cell Lung Cancer and Malignant Pleural Effusion
Primary Purpose
Non Small Cell Lung Cancer
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Medical thoracoscopic cryotherapy combined with standard first-line therapy for advanced non-cell lung cancer
Sequential intrathoracic injection of cisplatin/erythromycin combined with standard first-line therapy for advanced non-cell lung cancer
Standard first-line therapy for advanced non-cell lung cancer without intrathoracic treatment
Sponsored by
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring advanced Non-small Cell Lung Cancer, Malignant Pleural Effusion, Thoracoscopy, Cryotherapy Effect
Eligibility Criteria
Inclusion Criteria:
- 18-75 years old;
- Non-small cell lung cancer with pleural metastasis confirmed by histopathology or cytology;
- ECOG score 0-1;
- Cardiopulmonary function can tolerate painless thoracoscopic examination;
- Patients who underwent medical thoracoscopy for pleural effusion at first diagnosis and underwent medical thoracoscopy cryotherapy at the same time of biopsy were also included in the study. Non-small cell lung cancer was confirmed by pathological results;
- All subjects or their guardians must sign the informed consent before entering the study.
Exclusion Criteria:
- Expected survival <2 months;
- Hemoglobin <110g/L, white blood cell count <3×109/L, neutrophil <2.0×109/L, platelet <100×109/L;
- severe cardiac insufficiency, abnormal liver and kidney function (blood test results of transaminase and creatinine > 1.5 times the normal upper limit);
- have received chemotherapy or anti-angiogenic drugs (such as bevacizumab, endu, anlotinib, etc.);
- History of radiotherapy;
- history of intrathoracic local treatment;
- multiple serous cavity effusion, or bilateral pleural effusion;
- patients allergic to erythromycin;
- the lung cannot be reopened.
Sites / Locations
- Department of Respiratory, The First Affiliated Hospital of Shandong First Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Other
Arm Label
Experimental group (medical thoracoscopic cryotherapy)
Cisplatin/erythromycin control group (sequential intrathoracic injection of cisplatin/erythromycin)
Blank control group
Arm Description
Only intrathoracic tube was used to drain pleural effusion, and local pleural cavity was not treated.
Outcomes
Primary Outcome Measures
pleural progression free survival, P-PFS
According to Millar's criteria, P-PFS was defined as absence of pleural effusion lasting more than 4 weeks; Or an order of magnitude reduction in pleural effusion (such as large to medium volume, or medium to small volume) lasting more than 4 weeks; Or pleural effusion with no significant change, lasting more than 4 weeks.
Secondary Outcome Measures
Total effective rate
Complete remission (CR) : pleural effusion disappeared and lasted for more than 4 weeks; Partial remission (PR) : reduction of pleural effusion by 1 order of magnitude (e.g., large to medium volume, or medium to small volume) for more than 4 weeks; CR+PR was denoted as the total effective rate.
Progression-free survival (PFS)
modified Medical Research Council Dyspnea Scale
The modified Medical Research Council Dyspnea Scale (mMRC) is used to assess degree of baseline functional disability due to dyspnea. The minimum and maximum values are 0 and 4, and higher scores mean a worse outcome. Score 0 means dyspnea only with strenuous exercise; score 1 means dyspnea when hurrying or walking up a slight hill; score 2 means walks slower than people of the same age because of dyspnea or has to stop for breath when walking at own pace; score 3 means stops for breath after walking 100 yards (91 m) or after a few minutes; score 4 means too dyspneic to leave house or breathless when dressing.
Overall survival time
Adverse reactions
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05291403
Brief Title
Efficacy and Safety Study of Medical Thoracoscope Cryotherapy Combined Standard First-line Treatment of Advanced Non-small Cell Lung Cancer and Malignant Pleural Effusion
Official Title
The Efficacy and Safety Study of Medical Thoracoscope Cryotherapy Combined With Standard First-line Treatment of Advanced Non-small Cell Lung Cancer and Malignant Pleural Effusion: a Multicenter, Prospective, Randomized, Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 6, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qianfoshan 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
This study intends to investigate the efficacy and safety of medical thoracoscopic cryotherapy combined with standard first-line treatment of advanced non-small cell lung cancer with malignant pleural effusion through a randomized controlled clinical trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
advanced Non-small Cell Lung Cancer, Malignant Pleural Effusion, Thoracoscopy, Cryotherapy Effect
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
141 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group (medical thoracoscopic cryotherapy)
Arm Type
Experimental
Arm Title
Cisplatin/erythromycin control group (sequential intrathoracic injection of cisplatin/erythromycin)
Arm Type
Active Comparator
Arm Title
Blank control group
Arm Type
Other
Arm Description
Only intrathoracic tube was used to drain pleural effusion, and local pleural cavity was not treated.
Intervention Type
Other
Intervention Name(s)
Medical thoracoscopic cryotherapy combined with standard first-line therapy for advanced non-cell lung cancer
Intervention Description
Medical thoracoscopic cryotherapy: medical thoracoscopy biopsy hole insert bendable freezing probes, place the frozen probe placed in the center of the tumor at the top will be frozen carbon dioxide gas source pressure adjustment to the bar of 50-60 bar, tread down switch, foot pedal to start the probe, after about 30 s at the top of the probe to form a ice hockey, local tissue after frozen white, sometimes a small amount of bleeding; Fix the probe, loosen the pedal, and wait 30 seconds for automatic melting and rewarming (bleeding probability is low after full rewarming). Freeze 5 to 10 at a time.
In addition, all patients were treated with standard first-line regimens according to guidelines of non small cell lung cancer (NSCLC) and Eastern Cooperative Oncology Group (ECOG) scores.
Intervention Type
Other
Intervention Name(s)
Sequential intrathoracic injection of cisplatin/erythromycin combined with standard first-line therapy for advanced non-cell lung cancer
Intervention Description
The pleural effusion was fully drained and cisplatin 40mg/m2 was given, dissolved in 100mL 0.9% sodium chloride (NaCl) solution 100 mL, then injected into the pleural cavity and retained for 24 hours. Erythromycin was sequentially injected into the thorax to seal the pleural cavity.
In addition, all patients were treated with standard first-line regimens according to guidelines of NSCLC and ECOG scores.
Intervention Type
Other
Intervention Name(s)
Standard first-line therapy for advanced non-cell lung cancer without intrathoracic treatment
Intervention Description
Only intrathoracic tube was used to drain pleural effusion, and local pleural cavity was not treated.
In addition, all patients were treated with standard first-line regimens according to guidelines of NSCLC and ECOG scores.
Primary Outcome Measure Information:
Title
pleural progression free survival, P-PFS
Description
According to Millar's criteria, P-PFS was defined as absence of pleural effusion lasting more than 4 weeks; Or an order of magnitude reduction in pleural effusion (such as large to medium volume, or medium to small volume) lasting more than 4 weeks; Or pleural effusion with no significant change, lasting more than 4 weeks.
Time Frame
up to 2 months
Secondary Outcome Measure Information:
Title
Total effective rate
Description
Complete remission (CR) : pleural effusion disappeared and lasted for more than 4 weeks; Partial remission (PR) : reduction of pleural effusion by 1 order of magnitude (e.g., large to medium volume, or medium to small volume) for more than 4 weeks; CR+PR was denoted as the total effective rate.
Time Frame
up tp 2 months
Title
Progression-free survival (PFS)
Time Frame
up to 2 months
Title
modified Medical Research Council Dyspnea Scale
Description
The modified Medical Research Council Dyspnea Scale (mMRC) is used to assess degree of baseline functional disability due to dyspnea. The minimum and maximum values are 0 and 4, and higher scores mean a worse outcome. Score 0 means dyspnea only with strenuous exercise; score 1 means dyspnea when hurrying or walking up a slight hill; score 2 means walks slower than people of the same age because of dyspnea or has to stop for breath when walking at own pace; score 3 means stops for breath after walking 100 yards (91 m) or after a few minutes; score 4 means too dyspneic to leave house or breathless when dressing.
Time Frame
up to 2 months
Title
Overall survival time
Time Frame
up to 2 months
Title
Adverse reactions
Time Frame
up to 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-75 years old;
Non-small cell lung cancer with pleural metastasis confirmed by histopathology or cytology;
ECOG score 0-1;
Cardiopulmonary function can tolerate painless thoracoscopic examination;
Patients who underwent medical thoracoscopy for pleural effusion at first diagnosis and underwent medical thoracoscopy cryotherapy at the same time of biopsy were also included in the study. Non-small cell lung cancer was confirmed by pathological results;
All subjects or their guardians must sign the informed consent before entering the study.
Exclusion Criteria:
Expected survival <2 months;
Hemoglobin <110g/L, white blood cell count <3×109/L, neutrophil <2.0×109/L, platelet <100×109/L;
severe cardiac insufficiency, abnormal liver and kidney function (blood test results of transaminase and creatinine > 1.5 times the normal upper limit);
have received chemotherapy or anti-angiogenic drugs (such as bevacizumab, endu, anlotinib, etc.);
History of radiotherapy;
history of intrathoracic local treatment;
multiple serous cavity effusion, or bilateral pleural effusion;
patients allergic to erythromycin;
the lung cannot be reopened.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qian Qi, doctor
Phone
8613706380314
Email
qiqianqlh@163.com
Facility Information:
Facility Name
Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qian Qi, Doctor
Phone
+86 13706380314
Email
qiqianqlh@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Efficacy and Safety Study of Medical Thoracoscope Cryotherapy Combined Standard First-line Treatment of Advanced Non-small Cell Lung Cancer and Malignant Pleural Effusion
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