Update of Incidence, Prevalence, Survival, and Initial Treatment in Patients With Non-Small Cell Lung Cancer in the US.
Apar Kishor Ganti, Alyssa B Klein, Ion Cotarla...
https://pubmed.ncbi.nlm.nih.gov/34673888Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID06542159
Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Early-stage Non-small Cell Lung Cancer or Pulmonary Oligometastases: a Prospective, Randomized, Controlled Phase II Study
Led by Sun Yat-sen University · Updated on 2025-11-17
130
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of removing the planning target volume (PTV) margins during online adaptive stereotactic body radiotherapy (SBRT) for patients with early-stage non-small cell lung cancer (NSCLC) or pulmonary oligometastases. The study focuses on how this approach compares to standard SBRT in treating these lung conditions, aiming to improve treatment precision and patient outcomes in a controlled clinical setting. Participants are randomly assigned to one of two groups. The study group receives online adaptive SBRT without the usual PTV expansion margin, with a total radiation dose of 45-50 Gy delivered in 3 to 4 daily sessions. Both FBCT and 4DCT scans are used before each treatment session. The control group receives conventional SBRT with PTV expansion at the same dose and schedule, using CBCT scans prior to each session. This randomized design helps compare the new method against the standard approach. During the study, patients will be closely monitored through regular follow-up visits to evaluate safety and treatment effectiveness. Researchers will assess respiratory toxicity rates one year after treatment as the primary outcome. Secondary outcomes include tumor response two months post-radiotherapy and local tumor control over two years. Various tests and imaging techniques will be used to track progress and any side effects. The study duration includes treatment and extended observation to ensure comprehensive safety and efficacy data collection.
CONDITIONS
Brief Title
Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Early-stage Non-small Cell Lung Cancer or Pulmonary Oligometastases
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Histologically or PET-CT confirmed untreated early-stage non-small cell lung cancer (T1-2N0M0) that is inoperable or if the patient refuses surgery, or PET-CT/chest CT confirmed lung oligometastases with 3 or fewer lesions and a maximum diameter of 5 cm
- Age 18 years or older, any gender
- ECOG performance status score of 0 to 2
- Serum hemoglobin 80 g/L or higher, platelets 100,000/µL or higher, absolute neutrophil count 1,500/µL or higher
- Serum creatinine less than or equal to 1.25 times the upper normal limit or creatinine clearance 60 ml/min or higher
- Serum bilirubin less than or equal to 1.5 times the upper normal limit; AST (SGOT) and ALT (SGPT) less than or equal to 2.5 times the upper normal limit; alkaline phosphatase less than or equal to 5 times the upper normal limit
- Forced expiratory volume in 1 second (FEV1) 0.5 L or higher
- Normal CB6 range
- Patient and family agree and sign informed consent form
You will not qualify if you...
- Tumors with bronchial invasion
- Any disease or condition that contraindicates radiotherapy, such as active infections, heart disease including unstable angina, congestive heart failure, uncontrolled arrhythmias, or within 6 months after myocardial infarction
- Pregnant or breastfeeding women, or women without pregnancy testing
- History of substance abuse, chronic alcoholism, or AIDS
- Uncontrollable seizures or loss of self-control due to psychiatric disorders
- History of severe allergies or specific sensitivities
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 3 to 4 days
Participants receive stereotactic body radiotherapy (SBRT) either with online adaptive SBRT without PTV expansion margin or conventional standard SBRT with PTV expansion margin. Treatment consists of 3 to 4 daily radiation sessions.
3 to 4 visits (in-person, daily)
Follow-up
Duration - Up to 2 years
After treatment completion, participants are regularly followed up to assess safety and efficacy of the treatment.
Regular follow-up visits over 2 years
Trial Site Locations
Total: 1 location
1
Sun yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
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Research Team
B
Bo Qiu, Professor
H
Hui Liu, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Bing Sun, Eric D Brooks, Ritsuko U Komaki...
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Robert D Timmerman, Chen Hu, Jeff M Michalski...
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Michael C Roach, Cliff G Robinson, Todd A DeWees...
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Andrea Bezjak, Rebecca Paulus, Laurie E Gaspar...
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Cornelis J A Haasbeek, Frank J Lagerwaard, Ben J Slotman...
https://pubmed.ncbi.nlm.nih.gov/21892102Safety and Effectiveness of Stereotactic Ablative Radiotherapy for Ultra-Central Lung Lesions: A Systematic Review.
Hanbo Chen, Joanna M Laba, Sondos Zayed...
https://pubmed.ncbi.nlm.nih.gov/31075543Multi-institutional experience of stereotactic body radiotherapy for large (≥5 centimeters) non-small cell lung tumors.
Vivek Verma, Valerie K Shostrom, Sameera S Kumar...
https://pubmed.ncbi.nlm.nih.gov/27741355