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Clinical Trial NCT07412327 for Early-Stage Lung Cancer, Lung Cancer is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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A Single-Center, Prospective Phase II Clinical Study of Proton Beam Intensity-Modulated Stereotactic Radiotherapy for Early-Stage Non-Small Cell Lung Cancer 65 Short-Term
Clinical Trial NCT07412327 is an interventional study for Early-Stage Lung Cancer, Lung Cancer and is currently not yet recruiting. Enrollment is planned to begin on February 20, 2026 and continue until the study accrues 65 participants. Led by Guangzhou Concord Cancer Center, this study is expected to complete by July 1, 2029. The latest data from ClinicalTrials.gov was last updated on February 17, 2026.
Brief Summary
This study included patients with early-stage lung cancer cT1-3N0M0, stage IA-IIB (AJCC eighth edition staging) who were inoperable or refused surgery. They were divided into peripheral type and central type according to the tumor location and received radical proton hypofractionated radiotherapy. The prescribed dose for patients with peripheral lung cancer is 48-60Gy(RBE)/4-6 fractions, and for patients with central...Show More
Official Title
A Single-Center, Prospective Phase II Clinical Study of Proton Beam Intensity-Modulated Stereotactic Radiotherapy for Early-Stage Non-Small Cell Lung Cancer
Conditions
Early-Stage Lung CancerLung CancerOther Study IDs
- 2025-IIT-002
NCT ID Number
Start Date (Actual)
2026-02-20
Last Update Posted
2026-02-17
Completion Date (Estimated)
2029-07-01
Enrollment (Estimated)
65
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Proton therapy
hypofractionated radiotherapy
radiotherapy
Early-Stage Lung Cancer
lung cancer
SBPT
hypofractionated radiotherapy
radiotherapy
Early-Stage Lung Cancer
lung cancer
SBPT
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalStereotactic Body Proton Therapy The prescribed dose for patients with peripheral lung cancer is 48-60Gy(RBE)/4-6 fractions, and for patients with central lung cancer, the prescribed dose is 50-70Gy(RBE)/10-15 fractions. | Stereotactic Body Proton Therapy They were divided into peripheral type and central type according to the tumor location and received radical proton hypofractionated radiotherapy. The prescribed dose for patients with peripheral lung cancer is 48-60Gy(RBE)/4-6 fractions, and for patients with central lung cancer, the prescribed dose is 50-70Gy(RBE)/10-15 fractions. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Progression-free Survival | Progression Free Survival is defined as time from initiation of SBPT to disease progression or death from any cause. Estimated by the Kaplan-Meier method | Up to 3 years |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Overall Survival | Overall Survival is defined as time from initiation of SBPT to patient death from any cause. Estimated by the Kaplan-Meier method. | UP to 3 years |
Local Control Rate | Local control rate is defined as the proportion of participants with the absence of local failure among patients evaluable for efficacy in three years. | Up to 3 years |
Quality of life scores | QLQ-C30(V3.0) scores before treatment, weekly during treatment, at the end of treatment, and at each follow-up visit | Up to 3 years |
Quality of life scores | QLQ-LC29 scores before treatment, weekly during treatment, at the end of treatment, and at each follow-up visit | Up to 3 years |
Rate of grade 3-5 adverse events | The proportion of subjects with toxic reactions of levels 3, 4 and 5 during the clinical trial period.The researchers record AE that appeared during the clinical trial cycle and grade it according to CTCAE 5.0) | Up to 3 years |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- .Lung cancer confirmed by histology and/or cytology; and in the absence of pathological diagnosis, patients who meet the following conditions can also be included: diagnosed by more than 2 imaging modalities, and the clinical diagnosis of lung cancer is confirmed after MDT discussion.
- The clinical staging based on PET-CT examination is: cT1~3 N0M0, stage IA-IIB (AJCC eighth edition).
- Age: 18 years and above.
- KPS score ≥60.
- The doctor assesses that surgical treatment is not suitable or the patient refuses surgery.
- Relatively good organ function:
- Normal bone marrow function: WBC≥3×109/L, Platelet ≥80×109/L, HGB≥90g/L
- Normal liver and kidney function:
- Total bilirubin, AST, and ALT≤2.0×upper limit of normal values;
- Creatinine clearance ≥60ml/min or creatinine ≤1.5×upper limit of normal value
- The patient has signed an informed consent form and is willing and able to comply with planned study visits, treatment plans, laboratory tests, and other study procedures.
- Patients with other malignant tumors.
- Poorly controlled heart failure, respiratory failure, heart function, and lung function below grade 3 (including grade 3).
- Those whose laboratory test values do not meet relevant standards before enrollment.
- Patients who cannot cooperate with regular follow-up due to psychological, social, family and geographical reasons.
- Women of childbearing age who have a positive pregnancy test and women who are breastfeeding.
- Patients considered inappropriate for inclusion by other investigators.
Guangzhou Concord Cancer CenterNo contact data.
1 Study Locations in 1 Countries
Guangdong
Guangzhou Concord Cancer Center, Guangzhou, Guangdong, China