stage IA non-small cell lung cancer
Conditions
Interventions
Radiofrequency Ablation Group:Radiofrequency Ablation(RFA)
Stereotactic Body Radiotherapy Group:Stereotactic Body Radiotherapy(SBRT)
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years; 2.? Clinically staged as T1N0M0 non-small cell lung cancer (NSCLC).? 3. Pathologically confirmed NSCLC, or malignancy highly suspected based on PET-CT findings.? 4. ?Ineligibility for surgical resection due to one or more of the following:?? Impaired cardiopulmonary function or advanced age; Inability to undergo repeat surgery after prior lung surgery (due to cardiopulmonary dysfunction, pleural adhesions, etc.); Patient refusal of surgical resection; Severe anxiety unresponsive to psychological or pharmacological intervention; Active preference for radiofrequency ablation (RFA) or stereotactic body radiotherapy (SBRT). 5. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0–2.? 6. Ability to provide written informed consent (ICF), with full comprehension of and commitment to comply with study requirements and assessment schedules.?
Exclusion criteria
Exclusion criteria: 1. Prior treatment administered to the target lesion(s); 2. Clinical or radiological suspicion of lymph node metastasis.?; 3. Severely impaired cardiopulmonary function, or high risk of pneumothorax due to severe emphysema.?; 4.? Diagnosis of malignancies other than NSCLC within 5 years prior to enrollment.?; 5.? Concurrent participation in another interventional clinical study.?; 6. Pregnancy or lactation.?; 7.? Any condition potentially interfering with trial results or impeding study completion, including:?? Comorbidities, ongoing therapies, or abnormal laboratory values; Investigator judgment of unsuitability due to safety risks or protocol noncompliance. 8.? Diffuse bilateral pulmonary lesions where RFA/SBRT would not confer clinical benefit.?; 9. Extensive pleural metastasis with massive pleural effusion.?; 10. Technical infeasibility of RFA/SBRT due to:?? Tumor proximity to mediastinal great vessels; Contrast agent allergy or patient inability to cooperate, complicating needle pathway selection. 11.? Severely impaired pulmonary function (maximum ventilation volume < 40%).?; 12.? Contraindications to intervention:?? Platelet count <70 × 10?/L; Severe coagulopathy; Anticoagulant therapy within 1 week prior to ablation (requires discontinuation).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local Tumor Control Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| ?Adverse Event;Progression-Free Survival (PFS)?;Overall Survival (OS)?;Pulmonary Function;Lung Cancer-Specific Mortality;Scale Evaluation based on Patient-Reported Outcome (PRO) Database; | — |
Countries
China
Contacts
Public ContactZhao Liang
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed