Clinical trial NCT06503744: Transthoracic vs Transbronchial Ablation for Lung Cancer
Official title: Transthoracic Versus Transbronchial Ablation for Peripheral Lung Cancer Staging IA: a Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer Stage IA
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the efficacy and safety of transthoracic versus transbronchial ablation in the treatment of early stage peripheral lung cancer.

Detailed description: Ablation therapy has been widely used in the treatment of lung cancer and traditionally performed by CT-guided transthoracic puncture. In recent years, with the development of navigational bronchoscopy, exploratory studies on transbronchial ablation for peripheral lung cancer have demonstrated its efficacy and safety, but there is a lack of prospective randomized controlled trials to verify its near-term efficacy and safety, as well as its long-term efficacy. This study was designed as a prospective randomised controlled trial with 110 patients expected to participate in the study, randomized in a 1:1 ratio to CT-guided ablation and bronchoscopy-guided ablation treatment groups. The primary study endpoint is the rate of complete ablation at 6 months post-procedure. Secondary study endpoints were success rate of technique implementation, complete ablation rate at 12 months post-procedure, local control rate at 1, 2 and 3 years post-procedure, progression-free survival, overall survival and safety.

Eligibility criteria: Inclusion Criteria:

1. Age greater than 18 years.
2. Primary peripheral lung cancer diagnosed by pathology and pre-procedure staging examination suggesting clinical stage T1N0M0, stage IA (including postoperative new and multiple primary).
3. The proposed ablation lesion was evaluated for feasibility of CT and bronchoscopy-guided ablation treatment.
4. Consent to initial ablation therapy is given after assessment of unsuitability for surgery or refusal of surgery and signed informed consent form.

Exclusion Criteria:

1. Patients with platelets \<50×109/L, severe bleeding tendency and coagulation dysfunction that cannot be corrected in the short term.
2. Patients with severe pulmonary fibrosis and pulmonary arterial hypertension.
3. Infectious and radioactive inflammation around the lesion, skin infection at the puncture site that is not well controlled, systemic infection, high fever \>38.5°C.
4. Patients with severe hepatic, renal, cardiac, pulmonary and cerebral insufficiency, severe anaemia, dehydration and serious disorders of nutritional metabolism that cannot be corrected or improved in the short term.
5. Those with poorly controlled malignant pleural effusions.
6. Anticoagulation therapy and/or anti-platelet drugs (except dabigatran, rivaroxaban and other new oral anticoagulants) have not been discontinued more than 5\~7d before ablation.
7. Eastern Cooperative Oncology Group (ECOG) score \>2.
8. Combination of other tumours with extensive metastases and an expected survival of \<6 months.
9. Patients with episodic psychosis.
10. Patients with implanted electronic devices (e.g. pacemakers or defibrillators).
11. Pregnant women, or patients with a pregnancy planned during the study period.
12. Have participated or are participating in other clinical studies within the last 30 days.
13. Any other condition that the investigator considers inappropriate for participation in this study.

Primary outcomes:
measure: Complete ablation rate at 6 months post-procedure
timeFrame: Up to 6 months
Secondary outcomes:
measure: Success rate of technique implementation
timeFrame: Immediate postoperative
measure: Complete ablation rate at 12 months post-procedure
timeFrame: Up to 12 months
measure: Local control rate at 1, 2 and 3 years post-procedure
timeFrame: Up to 36 months
measure: Progression-free survival
timeFrame: Up to 36 months
measure: Overall survival
timeFrame: Up to 36 months
measure: Safety
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Chest Hospital
name: Jiayuan Sun, PhD
role: STUDY_DIRECTOR
References: