Comparing two methods of ablation for early-stage lung cancer

Transthoracic Versus Transbronchial Radiofrequency Ablation for Peripheral Lung Cancer Staging IA: a Prospective, Randomized Controlled Trial

This study is testing which of two different methods for treating early-stage lung cancer works better and is safer for patients.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Chest Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06503744 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy and safety of two different ablation techniques—transthoracic and transbronchial—for treating early-stage peripheral lung cancer. It is designed as a prospective randomized controlled trial involving 110 patients, who will be randomly assigned to either the CT-guided or bronchoscopy-guided ablation groups. The primary endpoint is the rate of complete ablation at six months post-procedure, while secondary endpoints include long-term local control rates and overall survival. The study aims to provide robust data on the effectiveness of these two approaches.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with primary peripheral lung cancer classified as stage IA who are not suitable for surgery.

Not a fit: Patients with severe comorbidities or those with conditions that complicate the ablation procedure may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the most effective ablation technique for early-stage lung cancer, potentially improving patient outcomes.

How similar studies have performed: While exploratory studies have shown promise for transbronchial ablation, this study is among the first to conduct a prospective randomized controlled trial comparing both techniques.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Jiayuan Sun, PhD

Conditions Lung Cancer Stage IA