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

Sun Yat-sen University

Status and phase: Enrolling; Phase 2

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

Treatments: Radiation: Online adaptive SBRT; Radiation: Conventional SBRT

Study type: Interventional

Funder types: Other

Identifiers

NCT06542159

GASTO-10116

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

The study group

Experimental group

Description:

Patients in the study group will receive online adaptive stereotactic body radiotherapy (without PTV expansion margin). The total dose will be 45-50Gy/3-4 fractions, administered once daily. Both FBCT and 4DCT will be acquired before initiating treatment at each fraction.

Treatment:

Radiation: Online adaptive SBRT

The control group

Active Comparator group

Description:

Patients in the control group will receive conventional standard stereotactic body radiotherapy. The total dose will be 45-50Gy/3-4 fractions, administered once daily. CBCT will be acquired before initiating treatment at each fraction.

Treatment:

Radiation: Conventional SBRT