Status:
RECRUITING
Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Early-stage Non-small Cell Lung Cancer or Pulmonary Oligometastases
Lead Sponsor:
Sun Yat-sen University
Conditions:
Adaptive Radiotherapy
Stereotactic Body Radiotherapy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 early-stage non-small ce...
Detailed 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 (NS...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 21 2028
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT06542159
Start Date
May 22 2024
End Date
April 21 2028
Last Update
November 17 2025
Active Locations (1)
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1
Sun yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060