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| ID | Type | Description | Link |
|---|---|---|---|
| TZ3582022-005 | Other Grant/Funding Number | Tianjin Medical University Cancer Institute and Hospital |
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This study aims to learn about the long-term safety and effectiveness of personalized stereotactic body radiotherapy (SBRT) in patients with early-stage peripheral non-small cell lung cancer (NSCLC). Individualized SBRT is a specialized radiation technique that delivers precise, high-dose treatment while minimizing damage to surrounding normal tissues.
The main question it aims to answer is:
Does individualized SBRT maintain local tumor control and patient survival at 3 years without significant side effects?
Patients with early-stage peripheral NSCLC who are medically inoperable or refuse surgery, and who are scheduled to receive individualized SBRT as their standard treatment, will provide the data to assess the safety and efficacy of this personalized radiation approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individualized SBRT for Early-Stage Peripheral NSCLC | Experimental | This single-arm cohort comprises patients with newly diagnosed, early-stage peripheral non-small-cell lung cancer (T1-2N0M0, IA-IIA) who receive individualized stereotactic body radiotherapy (SBRT) as standard-of-care. Participants will be prospectively followed for 3 years to assess overall survival, local control, progression-free survival, and adverse events. Inclusion criteria: age ≥18 years, pathologically confirmed NSCLC, tumor location ≥2 cm from the proximal bronchial tree, ECOG 0-2, and medically inoperable or refusal of surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ndividualized Stereotactic Body Radiotherapy (SBRT) System | Device | The individualized SBRT system employs advanced image-guided radiation delivery to deliver highly conformal, ablative doses to early-stage peripheral non-small-cell lung cancer while minimizing exposure to surrounding normal tissues. Treatment is delivered via a state-of-the-art robotic radiosurgery platform (e.g., CyberKnife M6) according to patient-specific fractionation schedules based on tumor size and proximity to critical structures, following standard indications and institutional protocols for medically inoperable or surgically refused cases. |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year overall survival (OS) | Three-year overall survival is defined as the proportion of participants who remain alive at 36 months from the start of individualized stereotactic body radiotherapy (SBRT). | Approximately 36 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year Progression-Free Survival (PFS) | Proportion of participants alive and without radiographic progression at 36 months. | Enrollment → 36 months |
| 3-year Local Control (LC) | Proportion of participants with no evidence of tumor recurrence at the irradiated site at 36 months. |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin 300060 | Tianjin | Tianjin Municipality | 300381 | China |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| Enrollment → 36 months |
| Objective Response Rate (ORR) | Percentage of participants achieving complete or partial response per RECIST 1.1 at 4 months after SBRT completion. | Enrollment → ~5 months (≈1 month to complete SBRT plus 4 months follow-up) |
| Adverse Event Incidence | Frequency and severity of all treatment-related toxicities graded by CTCAE 5.0, collected continuously. | Enrollment → 6 months after last SBRT fraction |
| Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin 300060 | Tianjin | Tianjin Municipality | China |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D004358 | Drug Therapy |