Lung Cancer (NSCLC)
Conditions
Keywords
lung cancer, radiotherapy, early stage
Brief 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 centrally located early-stage non-small cell lung cancer (NSCLC).
Interventions
RADIATIONOnline adaptive SBRT
Online adaptive SBRT (without PTV expansion margin). The total dose will be 39-42Gy/3 fractions, administered once daily. FBCT and 4DCT will be acquired.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed untreated early-stage non-small cell lung cancer (T1-2N0M0), or recurrent disease (rT1-2N0M0) that is inoperable or where the patient is unwilling to undergo surgery. * Centrally located lung cancer. * 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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of grade 3 or higher SBRT-related toxicity | 1-year | Incidence of grade 3 or higher SBRT-related toxicity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 2-year | PFS measures the time from the start date of SBRT to disease progression, death from any cause or last follow up if alive. |
| Objective response rate | 2 months after radiotherapy] | 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. |
| Local control rate | 2-year | The control of the local lesion after treatment. |
Countries
China
Contacts
Primary ContactDaQuan Wang, Dr.
Outcome results
None listed