Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Early-stage Non-small Cell Lung Cancer or Pulmonary Oligometastases

Phase 2

Recruiting

• Conditions: Toxicity; Stereotactic Body Radiotherapy; Non-small Cell Lung Cancer; Lung Oligometastases; Adaptive Radiotherapy
• Interventions: Radiation: Online adaptive SBRT; Radiation: Conventional SBRT

• Registration Number: NCT06542159
• 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 early-stage non-small cell lung cancer (NSCLC) or pulmonary oligometastases.

Detailed Description

This study aims to explore the safety and efficacy of eliminating the PTV expansion margin based on online adaptive stereotactic body radiotherapy (SBRT) for early-stage non-small cell lung cancer (NSCLC) or pulmonary oligometastases. In this study, patients will be stratified according to whether they have primary early-stage NSCLC, then randomly assigned in a 1:1 ratio to the study group or the control group. Patients in the study group will receive online adaptive SBRT (without PTV expansion margin), while patients in the control group will receive conventional standard SBRT. After the completion of treatment, patients will be followed up regularly to assess safety and efficacy.

Study Timeline

• Study Start: 2024-05-22
• Status Verified: 2024-08
• Study First Submitted: 2024-08-04
• Study First Submitted QC: 2024-08-04
• Last Update Submitted: 2024-08-04
• Study First Posted: 2024-08-07
• Last Update Posted: 2024-08-07
• Primary Completion: 2027-04-21
• Study Completion: 2028-04-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Histologically or PET-CT confirmed untreated early-stage non-small cell lung cancer (T1-2N0M0) that is inoperable or where the patient is unwilling to undergo surgery, or PET-CT/chest CT confirmed lung oligometastases (number of metastases ≤3, single lesion diameter ≤5cm).
• 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

• Tumors with bronchial invasion are excluded.
• 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: PARALLEL

Arm && Interventions

Group	Intervention	Description
The study group	Online adaptive SBRT	Patients in the study group will receive online adaptive stereotactic body radiotherapy (without PTV expansion margin). The total dose will be 45-50Gy/3-4 fractions, administered once daily. Both FBCT and 4DCT will be acquired before initiating treatment at each fraction.
The control group	Conventional SBRT	Patients in the control group will receive conventional standard stereotactic body radiotherapy. The total dose will be 45-50Gy/3-4 fractions, administered once daily. CBCT will be acquired before initiating treatment at each fraction.

Primary Outcome Measures

Name	Time	Method
Incidence of grade 2 or higher respiratory toxicity	1 year	Incidence of grade 2 or higher respiratory toxicity

Secondary Outcome Measures

Name	Time	Method
Local control rate	2 year	The control of the local lesion after treatment.
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.

Trial Locations

Locations (1)

Sun yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China