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

Recruiting now · Phase 2

Conditions studied: Adaptive Radiotherapy, Stereotactic Body Radiotherapy, Non-small Cell Lung Cancer, Lung Oligometastases, Toxicity

In brief

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.

Key facts

Study ID

NCT06542159

Run by

Sun Yat-sen University

People needed

130

Starts

2024-05-22

Expected to finish

2028-04-21

Last updated by the study team

2025-11-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or PET-CT confirmed untreated early-stage non-small cell lung cancer (T1-2N0M0) that is inoperable or where the patient is unwilling to undergo surgery, or PET-CT/chest CT confirmed lung oligometastases (number of metastases ≤3, single lesion diameter ≤5cm).
• Age 18 years or older, regardless of gender.
• ECOG performance status score of 0-2.
• Serum hemoglobin ≥ 80 g/L, platelets ≥ 100,000/μL, absolute neutrophil count ≥ 1,500/μL.
• Serum creatinine ≤ 1.25 times the upper normal limit (UNL) or creatinine clearance ≥ 60 ml/min.
• Serum bilirubin ≤ 1.5 times UNL, AST (SGOT) and ALT (SGPT) ≤ 2.5 times UNL, alkaline phosphatase ≤ 5 times UNL.
• FEV1 ≥ 0.5 L.
• Normal CB6 range.
• The patient and their family agree and sign the informed consent form.

You may not qualify if…

• Tumors with bronchial invasion are excluded.
• Any other disease or condition that contraindicates radiotherapy (e.g., active infections, within 6 months post-myocardial infarction, symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmias).
• Pregnant or breastfeeding women, women who have not undergone pregnancy testing, and pregnant individuals.
• Individuals with substance abuse issues, chronic alcoholism, or AIDS.
• Individuals with uncontrollable seizures or loss of self-control due to psychiatric disorders.
• Individuals with a history of severe allergies or specific sensitivities.

Where it is running

• Sun yat-sen University Cancer Center — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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