Actively Recruiting
A Prospective Phase II Clinical Study of Carbon Ion Radiotherapy for Locally Advanced Non-small Cell Lung Cancer in the Older Adult
Led by Jian Chen · Updated on 2025-06-13
29
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects and safety of carbon ion radiotherapy in patients over 75 years old with locally advanced non-small cell lung cancer. This study focuses on patients who are medically inoperable or refuse surgery, aiming to observe progression-free survival, toxicity, local control, cause-specific survival, and overall survival. The study is a Phase II clinical trial targeting older adults with this condition. Participants will receive carbon ion radiotherapy with a total dose of 70 Gy divided into 20 fractions. Those with genetic mutations such as EGFR or ALK are recommended to receive targeted therapy alongside radiotherapy. For patients not suitable for targeted therapy, single regimen chemotherapy drugs like etoposide, platinum agents, vinorelbine, paclitaxel, docetaxel, pemetrexel, or gemcitabine will be given sequentially with radiotherapy. If PD-1/PD-L1 immunotherapy is suitable, it may be combined or used as an alternative for those who cannot tolerate chemotherapy. During the study, participants will undergo regular follow-up visits to monitor disease progression and treatment side effects. Assessments include measuring progression-free survival from the start of radiotherapy to disease progression or death, as well as tracking treatment-related adverse events at specified intervals up to 100 months. Other outcomes such as local control rate, cause-specific survival, and overall survival are also evaluated. The study will continue monitoring participants for several years to gather comprehensive data on treatment outcomes and safety.
CONDITIONS
Brief Title
Carbon Ion Radiotherapy for Locally Advanced Lung Cancer in Elderly Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Older than 75 years old
- ECOG general status score of 0-2
- Primary non-small cell lung cancer confirmed by histology or cytological pathology, stage IIb-IIIc (AJCC/UICC 8th edition)
- Medically inoperable or refuses surgery
- Adequate organ function including blood, lung, cardiac, liver, and renal criteria
- Signed informed consent
You will not qualify if you...
- Previous treatment with bevacizumab for squamous cell carcinoma before carbon ion radiotherapy
- Uncontrolled other malignant tumors
- Particle radiotherapy plans not meeting dose coverage or normal tissue constraints
- History of chest radiation therapy or radioactive particle implantation
- Presence of cardiac pacemakers or metal implants affected by radiation
- HIV positive or active viral infections not controlled
- History of mental illness preventing treatment completion
- Serious comorbidities interfering with radiotherapy, including acute infections, unstable heart conditions, severe respiratory exacerbations, severe immune impairment, radiation-sensitive diseases
- Any other conditions deemed inappropriate by the physician for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of radiotherapy treatment plus concurrent systemic therapy as applicable
Participants receive carbon ion radiotherapy with 70 Gy delivered in 20 fractions. Depending on genetic mutations and tolerance, participants may also receive targeted therapy, single regimen chemotherapy, or immunotherapy in sequence with radiotherapy.
Approximately 20 visits for radiotherapy sessions and additional visits for systemic therapy as needed
Duration - Up to 100 months after radiotherapy starts
Participants are regularly followed to assess progression-free survival, treatment-related adverse events, local control, cause-specific survival, and overall survival.
Visits every 3-4 months during the first 2 years, every 6 months between years 3 and 5, and annually thereafter
Trial Site Locations
Total: 1 location
1
Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai Municipality, China, 201513
Actively Recruiting
Research Team
J
Jing Li
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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