Eliminating PTV Margins in Lung Cancer Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study explores the safety and efficacy of removing planning target volume (PTV) margins in online adaptive stereotactic body radiotherapy (SBRT) for patients with early-stage non-small cell lung cancer (NSCLC) or pulmonary oligometastases. Participants will be randomly assigned to receive either online adaptive SBRT without PTV margins or conventional SBRT. The study aims to determine if this approach can improve treatment outcomes while minimizing toxicity. Regular follow-ups will assess the safety and effectiveness of the treatments.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sun yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Hui Liu, Professor — Sun yat-sen universtiy cancer center
• Study coordinator: Bo Qiu, Professor
• Email: qiubo@sysucc.org.cn
• Phone: +862087343031

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.