Clinical trial NCT06542159: Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Early-stage Non-small Cell Lung Cancer or Pulmonary Oligometastases
Official title: Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Early-stage Non-small Cell Lung Cancer or Pulmonary Oligometastases: a Prospective, Randomized, Controlled Phase II Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Adaptive Radiotherapy
Stereotactic Body Radiotherapy
Non-small Cell Lung Cancer
Lung Oligometastases
Toxicity
Keywords: Online adaptive radiotherapy
Stereotactic body radiotherapy
Non-small Cell Lung Cancer
Lung oligometastases
Toxicity
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Incidence of grade 2 or higher respiratory toxicity
timeFrame: 1 year
Secondary outcomes:
measure: Objective response rate
timeFrame: 2 months after radiotherapy
measure: Local control rate
timeFrame: 2 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun yat-sen universtiy cancer center
name: Hui Liu, Professor
role: PRINCIPAL_INVESTIGATOR
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