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

Launched by SUN YAT-SEN UNIVERSITY · Aug 4, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new approach to treating early-stage non-small cell lung cancer (NSCLC) and certain lung metastases using a method called online adaptive stereotactic radiotherapy. The goal is to see if we can safely reduce the area around the tumor that we normally target with radiation, which could lead to fewer side effects while still effectively treating the cancer.

To participate in this trial, you need to be at least 18 years old and have been diagnosed with either early-stage NSCLC that cannot be surgically removed or a limited number of lung metastases. Participants will undergo a series of radiation treatments and will be closely monitored for safety and effectiveness. It’s important to note that certain health conditions and recent medical history may disqualify some individuals from joining. If you or a loved one are considering this trial, it’s a good idea to discuss it further with your healthcare provider to see if it’s the right option.

Gender

ALL

Eligibility criteria

• 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.