Carbon Ion Therapy for Peripheral Non-small Cell Lung Cancer

NCT ID: NCT05613452

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-29
• Study Completion Date: 2026-12-31

Brief 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.

Conditions

Non-small Cell Lung Cancer

Study Design

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

Study Groups

Study arm

patients received carbon ion radiotherapy

Group Type: EXPERIMENTAL

Carbon ion beam radiotherapy

Intervention Type: RADIATION

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.

Interventions

Carbon ion beam radiotherapy

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.

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Proton and Heavy Ion Center

OTHER

Sponsor Role: lead

Responsible Party

Jian Chen

Clinical Associate Professor

Responsibility Role: PRINCIPAL_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-THLC 2022-03

Identifier Type: -

Identifier Source: org_study_id