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

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

NCT ID: NCT06542159

Condition: Adaptive Radiotherapy
Stereotactic Body Radiotherapy
Non-small Cell Lung Cancer
Lung Oligometastases
Toxicity

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung

Conditions: Keywords:
Online adaptive radiotherapy
Stereotactic body radiotherapy
Non-small Cell Lung Cancer
Lung oligometastases
Toxicity

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: Online adaptive SBRT
Description: Online adaptive SBRT (without PTV expansion margin). The total dose will be 45-50Gy/3-4 fractions, administered once daily. FBCT and 4DCT will be acquired.
Arm group label: The study group

Intervention type: Radiation
Intervention name: Conventional SBRT
Description: SBRT with PTV expansion. The total dose will be 45-50Gy/3-4 fractions, administered once daily. CBCT will be acquired.
Arm group label: The control group

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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Sun yat-sen University Cancer Center

Address:
City: Guangzhou
Zip: 510060
Country: China

Status: Recruiting

Contact:
Last name: Hui Liu, MD

Phone: +86-020-87343031
Email: liuhuisysucc@126.com

Start date: May 22, 2024

Completion date: April 21, 2028

Lead sponsor:
Agency: Sun Yat-sen University
Agency class: Other

Source: Sun Yat-sen University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06542159