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

NCT06542159 · Sun Yat-sen University
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Official title
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
About this study
This study aims to explore the safety and efficacy of eliminating the PTV expansion margin based on online adaptive stereotactic body radiotherapy (SBRT) for early-stage non-small cell lung cancer (NSCLC) or pulmonary oligometastases. In this study, patients will be stratified according to whether they have primary early-stage NSCLC, then randomly assigned in a 1:1 ratio to the study group or the control group. Patients in the study group will receive online adaptive SBRT (without PTV expansion margin), while patients in the control group will receive conventional standard SBRT. After the completion of treatment, patients will be followed up regularly to assess safety and efficacy.
Eligibility criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Study design
Enrollment target: 130 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-05-22
Estimated completion: 2028-04-21
Last updated: 2025-11-17
Interventions
Radiation: Online adaptive SBRTRadiation: Conventional SBRT
Primary outcomes
  • Incidence of grade 2 or higher respiratory toxicity (1 year)
Sponsor
Sun Yat-sen University · other
Contacts & investigators
ContactBo Qiu, Professor · contact · qiubo@sysucc.org.cn · +862087343031
ContactHui Liu, Professor · contact · liuhui@sysucc.org.cn · +862087343031
InvestigatorHui Liu, Professor · principal_investigator, Sun yat-sen universtiy cancer center
All locations (1)
Sun yat-sen University Cancer CenterRecruiting
Guangzhou, Guangdong, China
Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Early-stage Non-small Cell Lung Cancer or Pulmonary Oligometastases · TrialPath