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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

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