This is a prospective, single-arm, single-center phase I/II clinical trial evaluating the safety, objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) of simultaneous integrated boost accelerated hyperfractionated radiotherapy in patients with high-proliferation non-small cell lung cancer (NSCLC).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥ 18 years, male or female;
2. Histologically or cytologically confirmed high-proliferation non-small cell lung cancer (NSCLC);
3. Assessed by a multidisciplinary team (MDT) and planned to receive thoracic radiotherapy (either curative or palliative), regardless of stage.
Exclusion Criteria:
1. Small cell histology;
2. Severe cardiac disease (New York Heart Association \[NYHA\] functional class ≥ III, uncontrolled arrhythmia, or myocardial infarction within the past 6 months);
3. Pregnant or breastfeeding women, or patients of childbearing potential who are unwilling to use effective contraceptive measures;
4. Concurrent participation in other interventional clinical trials;
5. Other conditions deemed by the investigator to make the patient unsuitable for enrollment (e.g., severe mental illness).
Primary outcome measure(s)
Incidence of Acute Treatment-Related Toxicity — From the start of radiotherapy through 90 days after completion of radiotherapy. The incidence and severity of acute treatment-related toxicities will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Incidence of Late Treatment-Related Toxicity — From more than 90 days after completion of radiotherapy through 2 years after completion of radiotherapy. The incidence and severity of late treatment-related toxicities will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Trial sites (1)
Facility
City
Region
Status
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou
Zhejiang
Recruiting
More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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