Carbon Ion Radiotherapy for Locally Advanced Lung Cancer in Elderly Patients

NCT ID: NCT06311981

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-08
• Study Completion Date: 2026-06-17

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.

Conditions

Non-small Cell Lung Cancer; Older People; Carbon Ion Radiotherapy; Radiotherapy Side Effect

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study arm

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.

Group Type: EXPERIMENTAL

carbon ion radiotherapy

Intervention Type: RADIATION

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.

targeted therapy

Intervention Type: OTHER

targeted therapy

single regimen chemotherapy in sequence with radiotherapy

Intervention Type: OTHER

single regimen chemotherapy in sequence with radiotherapy

Interventions

carbon ion radiotherapy

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.

Intervention Type: RADIATION

targeted therapy

targeted therapy

Intervention Type: OTHER

single regimen chemotherapy in sequence with radiotherapy

single regimen chemotherapy in sequence with radiotherapy

Intervention Type: OTHER

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.

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jian Chen

OTHER

Sponsor Role: lead

Responsible Party

Jian Chen

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jingfang Mao, PHD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Proton and Heavy Ion Center

Locations

Shanghai Proton and Heavy Ion Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jing Li

Role: CONTACT

jing.li@sphic.org.cn

86-21-38296678

Facility Contacts

Jing Li

Role: primary

jing.li@sphic.org.cn

86-21-38296678

Kun Liu

Role: backup

kun.liu@sphic.org.cn

86-21-38296678

Other Identifiers

SPHIC-TR-THLC2023-08

Identifier Type: -

Identifier Source: org_study_id