Eliminating margins in radiotherapy for early-stage lung cancer
Official title: Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Centrally Located Early-stage Non-small Cell Lung Cancer: a Prospective, Single-arm, Phase II Study
Run by Sun Yat-sen University · NCT06730295 · Data updated 2026-11-12
This study tests if removing extra safety margins in radiation treatment can help patients with early-stage lung cancer get better results while adapting to changes in their tumor's position.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 52 (estimated) |
| Sponsor | Sun Yat-sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | December 10, 2024 |
| Main results expected | November 30, 2027 |
| Study ends | November 30, 2028 |
| Registry record updated | March 12, 2025 |
| Trial ID | NCT06730295 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with untreated or recurrent centrally located early-stage non-small cell lung cancer.
✕Probably not a fit
Patients with conditions that contraindicate radiotherapy or those with advanced disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the safety and effectiveness of removing planning target volume margins in online adaptive stereotactic radiotherapy for patients with centrally located early-stage non-small cell lung cancer (NSCLC). The approach focuses on delivering precise radiation treatment while adapting to changes in tumor position. Patients with histologically confirmed NSCLC who are inoperable or unwilling to undergo surgery will be enrolled. The study aims to improve treatment outcomes by optimizing radiotherapy techniques.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and safer radiotherapy for patients with early-stage lung cancer.
How similar studies have gone: Other studies have shown promise in using adaptive radiotherapy techniques, suggesting potential for success in this novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China Recruiting
Study contacts
- Study coordinator: DaQuan Wang, Dr.
- Email: wangdq@sysucc.org.cn
- Phone: +862087343031
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.