RecruitingPhase 2NCT06542159

Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Early-stage Non-small Cell Lung Cancer or Pulmonary Oligometastases

Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Early-stage Non-small Cell Lung Cancer or Pulmonary Oligometastases: a Prospective, Randomized, Controlled Phase II Study


Sponsor

Sun Yat-sen University

Enrollment

130 participants

Start Date

May 22, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to explore the safety and efficacy of eliminating the PTV (planning target volume) margins based on online adaptive stereotactic radiotherapy for patients with early-stage non-small cell lung cancer (NSCLC) or pulmonary oligometastases.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing an advanced radiation therapy technique that adapts the treatment plan in real time to account for tumor movement — such as breathing — in people with early-stage non-small cell lung cancer or a small number of lung metastases. The goal is to deliver highly precise radiation (called stereotactic body radiotherapy, or SBRT) directly to the tumor while reducing the safety margin around it, potentially causing less damage to surrounding healthy lung tissue. **You may be eligible if...** - You are 18 or older with early-stage non-small cell lung cancer (T1-2, N0, M0) that cannot be surgically removed, or up to 3 lung metastases (each under 5 cm) - Your cancer has been confirmed by biopsy or PET-CT scan - You are reasonably functional (ECOG 0–2) and your blood counts and organ function meet minimum levels **You may NOT be eligible if...** - You have more than 3 lung metastases or tumors larger than 5 cm - Your lung function is severely impaired - You have active infections or serious organ problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONOnline adaptive SBRT

Online adaptive SBRT (without PTV expansion margin). The total dose will be 45-50Gy/3-4 fractions, administered once daily. FBCT and 4DCT will be acquired.

RADIATIONConventional SBRT

SBRT with PTV expansion. The total dose will be 45-50Gy/3-4 fractions, administered once daily. CBCT will be acquired.


Locations(1)

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06542159


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