Personalized SBRT in Early-Stage Peripheral NSCLC

Not Applicable

• Conditions: Early-stage Peripheral Non-small Cell Lung Cancer

• Registration Number: NCT07167459
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-04
• Status Verified: 2025-09
• Study First Submitted: 2025-09-04
• Study First Submitted QC: 2025-09-04
• Last Update Submitted: 2025-09-04
• Study First Posted: 2025-09-11
• Last Update Posted: 2025-09-11
• Primary Completion: 2029-03-01
• Study Completion: 2029-03-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 251

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
3-year overall survival (OS)	Approximately 36 months after enrollment	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).

Secondary Outcome Measures

Name	Time	Method
3-year Progression-Free Survival (PFS)	Enrollment → 36 months	Proportion of participants alive and without radiographic progression at 36 months.
3-year Local Control (LC)	Enrollment → 36 months	Proportion of participants with no evidence of tumor recurrence at the irradiated site at 36 months.
Objective Response Rate (ORR)	Enrollment → ~5 months (≈1 month to complete SBRT plus 4 months follow-up)	Percentage of participants achieving complete or partial response per RECIST 1.1 at 4 months after SBRT completion.
Adverse Event Incidence	Enrollment → 6 months after last SBRT fraction	Frequency and severity of all treatment-related toxicities graded by CTCAE 5.0, collected continuously.

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin 300060; 🇨🇳 Tianjin, Tianjin Municipality, China