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
Sun Yat-sen University
130 participants
May 22, 2024
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
Inclusion Criteria9
- 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 Criteria6
- 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.
Interventions
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.
SBRT with PTV expansion. The total dose will be 45-50Gy/3-4 fractions, administered once daily. CBCT will be acquired.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06542159