Comparing two methods for treating early-stage peripheral lung cancer

Transbronchial Versus Transthoracic Ablation for Early Stage Peripheral Lung Cancer: a Prospective, Randomized Controlled Trial

This study is testing two different ways to use radiofrequency ablation to treat early-stage lung cancer and see which method works better for patients.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hangzhou Broncus Medical Co., Ltd. (industry)
• Drugs / interventions: radiation
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06052098 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy and safety of radiofrequency ablation (RFA) for early-stage peripheral lung cancer using two different approaches: transthoracic and transbronchial. It is a prospective, randomized controlled trial involving 110 participants, who will be assigned in a 1:1 ratio to either CT-guided or bronchoscopy-guided RFA groups. The primary endpoint is the complete ablation rate at 6 months, while secondary endpoints include technical success, local control rates, progression-free survival, overall survival, and safety assessments over a period of up to 3 years.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with primary peripheral lung cancer classified as stage IA who are inoperable or have refused surgery.

Not a fit: Patients with severe comorbidities or uncontrolled infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective and safer treatment option for patients with early-stage peripheral lung cancer.

How similar studies have performed: Previous studies have shown promising results with radiofrequency ablation for lung cancer, suggesting this approach may be effective, though the specific comparison of these two methods is novel.

Eligibility criteria

Inclusion Criteria:

1. Age greater than 18 years.
2. Primary peripheral lung cancer diagnosed by pathology, and preoperative staging reveals clinical stage T1N0M0, stage IA.
3. The planned ablation lesions are assessed to be amenable to CT-guided and bronchoscopy-guided ablation.
4. Assessed as inoperable or refused surgery, agree to undergo initial ablation therapy, and sign informed consent.

Exclusion Criteria:

1. Patients with platelet \< 50 × 10 9/L, severe bleeding tendency and coagulation dysfunction that cannot be corrected in a short period of time.
2. Patients with severe pulmonary fibrosis and pulmonary hypertension.
3. Perilesional infection and radiation inflammation, puncture site skin infection is not well controlled, systemic infection, high fever \> 38.5℃.
4. Patients with severe liver, kidney, heart, lung and brain dysfunction, severe anemia, dehydration and severe nutritional metabolism disorders that cannot be corrected or improved in a short period of time.
5. Patients with poorly controlled malignant pleural effusion.
6. Anticoagulation therapy and/or antiplatelet agents (except novel oral anticoagulants such as dabigatran and rivaroxaban) are discontinued for less than 5\~7 days before ablation.
7. Eastern Cooperative Oncology Group (ECOG) score \> 2.
8. Combined with other tumors with extensive metastasis, expected survival \< 6 months.
9. Patients with episodic psychosis.
10. Patients with implantable electronic devices (such as pacemaker or defibrillator).
11. Pregnant women, or patients who have pregnancy plans during the study.
12. Participation or ongoing participation in another clinical study within the past 30 days.
13. Other situations that the investigator deems inappropriate to participate in this study.

Where this trial is running

Shanghai, Shanghai Municipality

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

Study contacts

• Principal investigator: Jiayuan Sun, MD, PhD — Shanghai Chest Hospital
• Study coordinator: Jiayuan Sun, MD, PhD

Conditions: Stage IA Lung Cancer