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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
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.
Sun yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGIncidence of grade 2 or higher respiratory toxicity
Incidence of grade 2 or higher respiratory toxicity
Time frame: 1 year
Objective response rate
Objective Response Rate (ORR) is defined as the proportion of patients whose tumor size decreases to a pre-specified value and is maintained for a certain period of time during cancer treatment. It includes the number of patients with Complete Response (CR) and Partial Response (PR) as a percentage of the total number of evaluable cases.
Time frame: 2 months after radiotherapy
Local control rate
The control of the local lesion after treatment.
Time frame: 2 year
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