Trial Title:
Carbon Ion Radiotherapy for Locally Advanced Lung Cancer in Elderly Patients
NCT ID:
NCT06311981
Condition:
Non-small Cell Lung Cancer
Older People
Carbon Ion Radiotherapy
Radiotherapy Side Effect
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 radiotherapy
Description:
The patient will receive carbon ion radiotherapy with 70Gy per 20 fractions. Patients
with genetic mutations (including but not limited to EGFR, ALK, etc.) should receive
targeted therapy as their systemic therapy. For patients who are not suitable for
targeted therapy, we recommend single regimen chemotherapy in sequence with radiotherapy.
The drugs include etoposide, platinum (carboplatin, cisplatin, nedaplatin or loplatin),
vinorelbine, paclitaxel (including liposome paclitaxel and albumin paclitaxel),
docetaxel, pemetrexel, gemcitabine, etc. If there is no contraindication to PD-1/PD-L1
immunotherapy, it can be combined with immunotherapy, such as Pembrolizumab. For patients
who cannot tolerate chemotherapy, PD-1/PD-L1 immunotherapy is recommended. The
progression-free survival rate, toxicity, local control rate, cause-specific survival
rate and overall survival rate were observed with regular follow-up after treatment.
Arm group label:
Study arm
Intervention type:
Other
Intervention name:
targeted therapy
Description:
targeted therapy
Arm group label:
Study arm
Intervention type:
Other
Intervention name:
single regimen chemotherapy in sequence with radiotherapy
Description:
single regimen chemotherapy in sequence with radiotherapy
Arm group label:
Study arm
Summary:
To observe the effect and toxicity of carbon ion radiotherapy on local advanced non-small
cell lung cancer over 75 years old patients. Systemic therapy could be targeted therapy,
chemotherapy or immunotherapy.
Detailed description:
The patient will receive carbon ion radiotherapy with 70Gy per 20 fractions. Patients
with genetic mutations (including but not limited to EGFR, ALK, etc.) should receive
targeted therapy as their systemic therapy. For patients who are not suitable for
targeted therapy, we recommend single regimen chemotherapy in sequence with radiotherapy.
The drugs include etoposide, platinum (carboplatin, cisplatin, nedaplatin or loplatin),
vinorelbine, paclitaxel (including liposome paclitaxel and albumin paclitaxel),
docetaxel, pemetrexel, gemcitabine, etc. If there is no contraindication to PD-1/PD-L1
immunotherapy, it can be combined with immunotherapy, such as Pembrolizumab. For patients
who cannot tolerate chemotherapy, PD-1/PD-L1 immunotherapy is recommended. The
progression-free survival rate, toxicity, local control rate, cause-specific survival
rate and overall survival rate were observed with regular follow-up after treatment.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Older than 75 years old.
- ECOG general status score of 0-2.
- Primary non-small cell lung cancer (NSCLC) confirmed by histology or cytological
pathology, T1-4N1-3M0, stage IIb-IIIc (AJCC/UICC 8th edition).
- 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 informed consent.
Exclusion Criteria:
- Patient with squamous cell carcinoma was treated with bevacizumab before carbon ion
radiotherapy.
- 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.
- 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.
Gender:
All
Minimum age:
75 Years
Maximum age:
N/A
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:
Jian Chen, MD
Email:
Principal Investigator
Investigator:
Last name:
Jingfang Mao, PHD
Email:
Principal Investigator
Investigator:
Last name:
Kai-liang Wu, PHD
Email:
Principal Investigator
Start date:
April 1, 2024
Completion date:
June 17, 2026
Lead sponsor:
Agency:
Jian Chen
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/NCT06311981