Recruiting NCT05613452
Carbon Ion Therapy for Peripheral Non-small Cell Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Carbon ion beam radiotherapy.
- Who it may be relevant to
- Registry conditions: Non-small Cell Lung Cancer. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Phase II Clinical Study of Carbon Ion Beam Stereotactic Radiotherapy for Peripheral Type Early-stage Non-small Cell Lung Cancer
Overview
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.
Interventions
- Radiation Carbon 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.
Primary outcome measures
- disease progression-free survival rate [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 outcome measures (3)
- local control rate [Time frame: From date of radiotherapy started until the date of first documented local disease progression, assessed up to 100 months]
- overall survival rate [Time frame: From date of radiotherapy started until the date of death from any cause, assessed up to 100 months]
- Incidence of Treatment-induced Adverse Events [Safety and Tolerability] [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]
Eligibility criteria
Inclusion criteria
- Between the ages of 18 and 80.
- ECOG general status score of 0-2 .
- Primary non-small cell lung cancer (NSCLC) confirmed by histology or cytological pathology, T1-2N0M0, stage Ia-IIa (AJCC/UICC 8th edition).
- 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).
- Medically inoperable, or patient refuses surgery.
- 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.
- Sign the informed consent.
Exclusion criteria
- Multiple primary tumors.
- Patient fails to comply with the treatment protocol.
- Complicated with other malignant tumors that have not been controlled.
- 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.
- Chest radiation therapy or radioactive particle implantation history.
- 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.
- Pregnancy (confirmed by serum or urine β-HCG test) or lactation period.
- HIV positive. Hepatitis virus replication phase, need to receive antiviral therapy, but because of concomitant disease cannot receive antiviral therapy. Active stage of syphilis.
- A history of mental illness may hinder the completion of treatment.
- 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.
- Other circumstances that the physician considers inappropriate to participate in clinical study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Proton and Heavy Ion Center — Shanghai
Identifiers
NCT: NCT05613452 · SPHIC-TR-THLC 2022-03