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RecruitingNCT05613452Updated Jun 13, 2025

Carbon Ion Therapy for Peripheral Non-small Cell Lung Cancer

A Phase 2 interventional study of Carbon ion beam radiotherapy in Non-small Cell Lung Cancer, sponsored by Shanghai Proton and Heavy Ion Center. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-06-13.

Sponsored by Shanghai Proton and Heavy Ion Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
43
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

To investigate the efficacy of carbon ion therapy for stage Ia-IIa primary peripheral non-small cell lung cancer (NSCLC). The primary endpoint was progression-free survival (PFS), and the secondary endpoint was local control rate, overall survival (OS) and toxicities.

02

Conditions studied

  • Non-small Cell Lung Cancer
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Between the ages of 18 and 80.
  2. ECOG general status score of 0-2 .
  3. Primary non-small cell lung cancer (NSCLC) confirmed by histology or cytological pathology, T1-2N0M0, stage Ia-IIa (AJCC/UICC 8th edition).
  4. The location of the tumor belongs to the peripheral type defined in this study (2cm and beyond (≥2cm) from the esophagus, main bronchial tree, spinal cord, heart, great blood vessels, brachial plexus and stomach, and 1cm and beyond (≥1cm) from the chest wall).
  5. Medically inoperable, or patient refuses surgery.
  6. Adequate organ function: 1). Blood function: absolute neutrophil count (ANC) ≥1.5 x 109/L, platelet count ≥80 x 109/L, hemoglobin ≥9 g/dL 2). Lung function: FEV1>25%, DLCO>25% 3). Cardiac function: no serious pulmonary hypertension, cardiovascular and cerebrovascular diseases, peripheral vascular diseases, serious chronic heart disease and other complications that may affect radiotherapy.4). Adequate liver function: total bilirubin \<1.5 times the upper limit of normal value, and AST, ALT\<2 times the upper limit of normal value. 5). Adequate renal function: serum creatinine ≤1.5 times the upper limit of normal or calculated creatinine clearance ≥50 ml /min, and urinary protein \<2+. Patients with a baseline urinary protein level of 2+ or more should have a 24-hour urine collection and evidence of a 24-hour urinary protein level of 1g or less.
  7. Sign the informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Multiple primary tumors.
  2. Patient fails to comply with the treatment protocol.
  3. Complicated with other malignant tumors that have not been controlled.
  4. Patient whose particle radiotherapy plan cannot meet the minimum target dose coverage and dose volume limitation requirements, or cannot meet the dose constrains of normal tissue or organs.
  5. Chest radiation therapy or radioactive particle implantation history.
  6. Cardiac pacemakers or other internal metal prosthesis implants that may be affected by high-energy radiation or may affect the dose distribution to the radiation target area.
  7. Pregnancy (confirmed by serum or urine β-HCG test) or lactation period.
  8. HIV positive. Hepatitis virus replication phase, need to receive antiviral therapy, but because of concomitant disease cannot receive antiviral therapy. Active stage of syphilis.
  9. A history of mental illness may hinder the completion of treatment.
  10. With serious comorbidity that may interfere with radiotherapy, including: (a) Acute infectious diseases or acute active phase of chronic infection. b) Unstable angina pectoris, congestive heart failure, myocardial infarction that has been hospitalized in the past 6 months. c) Exacerbations of chronic obstructive pulmonary disease or other respiratory conditions requiring hospitalization. d) Severely impaired immune function. e) Diseases with excessive sensitivity to radiation such as ataxia telangiectasia. f) Other diseases that may affect particle radiotherapy.
  11. Other circumstances that the physician considers inappropriate to participate in clinical study.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
43 participants (estimated)

Study arms

  • Experimental
    Study arm

    patients received carbon ion radiotherapy

    Radiation: Carbon ion beam radiotherapy

Interventions

  • RadiationCarbon ion beam radiotherapy

    Patients receive carbon ion radiotherapy of 12GyE per fraction, totally 4 fractions. Patients with tumors ≥4cm should receive at least 4 cycles of platinum-based doublet chemotherapy.

05

What researchers measure

Primary outcomes

  1. disease progression-free survival rate

    disease progression-free survival rate was defined from the start of carbon ion radiotherapy till the date of disease progression at any site or death, or the last follow up.

    Time frame: From date of radiotherapy started until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Secondary outcomes

  1. local control rate

    local control rate was defined was defined from the start of carbon ion radiotherapy till the date of local failure or the last follow-up

    Time frame: From date of radiotherapy started until the date of first documented local disease progression, assessed up to 100 months

  2. overall survival rate

    overall survival rate was defined from the start of carbon ion radiotherapy till the date of death or the last follow-up

    Time frame: From date of radiotherapy started until the date of death from any cause, assessed up to 100 months

  3. Incidence of Treatment-induced Adverse Events [Safety and Tolerability]

    Treatment-induced toxicities were scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, for events observed after the first dose of irradiation. Toxicities occurred 90 or more days after the completion of CIRT were defined as late toxicities.

    Time frame: From date of radiotherapy started, every 3-4 months within the first 2 years, every 6 months between years 3 and 5, and annually thereafter, assessed up to 100 months

06

Study locations

1 of 1 sites recruiting
  • Shanghai Proton and Heavy Ion Center
    Shanghai, Shanghai 201513, China
    • Jing Li · Contact · jing.li@sphic.org.cn · 86-21-38296678
    • Kun Liu · Contact · kun.liu@sphic.org.cn · 86-21-38296678
    • Jingfang Mao, PHD · Principal investigator
    • Kai-liang Wu, PHD · Sub investigator
    • Jian Chen, MD · Sub investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05613452
Lead sponsor
Shanghai Proton and Heavy Ion Center
Responsible party
Jian Chen (Clinical Associate Professor, Shanghai Proton and Heavy Ion Center) — Principal investigator
First posted
Nov 14, 2022
Start date
Sep 29, 2024
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jun 13, 2025

Study contacts

Jing Li
Contact
jing.li@sphic.org.cn
86-21-38296678
Jingfang Mao, PHD
principal investigator · Shanghai Proton and Heavy Ion Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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