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Trial Title:
Carbon Ion Therapy for Peripheral Non-small Cell Lung Cancer
NCT ID:
NCT05613452
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Carbon ion beam radiotherapy
Description:
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.
Arm group label:
Study arm
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.
Criteria for eligibility:
Criteria:
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:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Proton and Heavy Ion Center
Address:
City:
Shanghai
Zip:
201513
Country:
China
Status:
Recruiting
Contact:
Last name:
Jing Li
Phone:
86-21-38296678
Email:
jing.li@sphic.org.cn
Contact backup:
Last name:
Kun Liu
Phone:
86-21-38296678
Email:
kun.liu@sphic.org.cn
Investigator:
Last name:
Jingfang Mao, PHD
Email:
Principal Investigator
Investigator:
Last name:
Kai-liang Wu, PHD
Email:
Sub-Investigator
Investigator:
Last name:
Jian Chen, MD
Email:
Sub-Investigator
Start date:
March 1, 2024
Completion date:
January 2026
Lead sponsor:
Agency:
Shanghai Proton and Heavy Ion Center
Agency class:
Other
Source:
Shanghai Proton and Heavy Ion Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05613452
