Clinical trial NCT06311981: Carbon Ion Radiotherapy for Locally Advanced Lung Cancer in Elderly Patients
Official title: A Prospective Phase II Clinical Study of Carbon Ion Radiotherapy for Locally Advanced Non-small Cell Lung Cancer in the Older Adult
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Older People
Carbon Ion Radiotherapy
Radiotherapy Side Effect
Lead sponsor: Shanghai Proton and Heavy Ion Center
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 29
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Disease progression-free survival rate
timeFrame: 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.
measure: Incidence of Treatment-induced Adverse Events
timeFrame: 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.
Secondary outcomes:
measure: Local control rate
timeFrame: From date of radiotherapy started until the date of first documented local disease progression, assessed up to 100 months.
measure: Cause-specific survival rate
timeFrame: From date of radiotherapy started until the date of first documented death caused by non-small cell lung cancer treated in this study, assessed up to 100 months.
measure: Overall survival rate
timeFrame: From date of radiotherapy started until the date of death from any cause, assessed up to 100 months.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Proton and Heavy Ion Center
state: Shanghai
Study officials:
affiliation: Shanghai Proton and Heavy Ion Center
name: Jingfang Mao, PHD
role: PRINCIPAL_INVESTIGATOR
References: