Non-Small Cell Lung Cancer
Conditions
Keywords
non-small cell lung cancer, hyperfractionated radiotherapy
Brief summary
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).
Interventions
RADIATIONhyperfractionated radiotherapy
simultaneous integrated boost accelerated hyperfractionated radiotherapy
Sponsors
Second Affiliated Hospital, Zhejiang University, School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Every 3 months after completion of radiotherapy, up to 2 years. | Objective response rate is defined as the proportion of participants who achieve a best overall response of complete response (CR) or partial response (PR), as assessed according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. |
| Progression-Free Survival (PFS) | From enrollment until documented disease progression or death from any cause, up to 2 years. | Progression-free survival is defined as the time from enrollment to the first documented disease progression or death from any cause, whichever occurs first. Disease progression will be assessed according to RECIST version 1.1. |
| Overall Survival (OS) | From enrollment until death from any cause, up to 2 years. | Overall survival is defined as the time from enrollment to death from any cause. |
Countries
China
Contacts
CONTACTLu Wang
PRINCIPAL_INVESTIGATORTing Zhang
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Outcome results
None listed