Clinical trial NCT06730295: Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Centrally Located Early-stage Non-small Cell Lung Cancer
Official title: Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Centrally Located Early-stage Non-small Cell Lung Cancer: a Prospective, Single-arm, Phase II Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Lung Cancer (NSCLC)
Keywords: lung cancer
radiotherapy
early stage
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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 centrally located early-stage non-small cell lung cancer (NSCLC).


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of grade 3 or higher SBRT-related toxicity
timeFrame: 1-year
Secondary outcomes:
measure: Objective response rate
timeFrame: 2 months after radiotherapy]
measure: Local control rate
timeFrame: 2-year
measure: Progression-free survival
timeFrame: 2-year
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References:
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