Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Centrally Located Early-stage Non-small Cell Lung Cancer

Phase 2

Recruiting

• Conditions: Lung Cancer (NSCLC)

• Registration Number: NCT06730295
• Lead Sponsor: Sun Yat-sen University

Brief Summary

This study aims to explore the safety and efficacy of eliminating the PTV (planning target volume) margins based on online adaptive stereotactic radiotherapy for patients with centrally located early-stage non-small cell lung cancer (NSCLC).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-09
• Study First Submitted QC: 2024-12-09
• Study Start: 2024-12-10
• Study First Posted: 2024-12-12
• Last Update Submitted: 2025-03-09
• Last Update Posted: 2025-03-12
• Primary Completion: 2027-11-30
• Study Completion: 2028-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence of grade 3 or higher SBRT-related toxicity	1-year	Incidence of grade 3 or higher SBRT-related toxicity

Secondary Outcome Measures

Name	Time	Method
Objective response rate	2 months after radiotherapy]	Objective Response Rate (ORR) is defined as the proportion of patients whose tumor size decreases to a pre-specified value and is maintained for a certain period of time during cancer treatment. It includes the number of patients with Complete Response (CR) and Partial Response (PR) as a percentage of the total number of evaluable cases.
Local control rate	2-year	The control of the local lesion after treatment.
Progression-free survival	2-year	PFS measures the time from the start date of SBRT to disease progression, death from any cause or last follow up if alive.

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 GuangZhou, Guangdong, China