Eliminating margins in radiotherapy for early-stage lung cancer
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
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 |
| Enrollment | 52 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06730295 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with untreated or recurrent centrally located early-stage non-small cell lung cancer.
Not a fit: Patients with conditions that contraindicate radiotherapy or those with advanced disease may not benefit from this study.
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 performed: Other studies have shown promise in using adaptive radiotherapy techniques, suggesting potential for success in this novel approach.
Eligibility criteria
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 this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: DaQuan Wang, Dr.
- Email: wangdq@sysucc.org.cn
- Phone: +862087343031
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.