Carbon Ion Radiotherapy for Locally Advanced Lung Cancer in Elderly Patients

NCT06311981 | Recruiting Phase 2 DMC

• 1 other identifier: SPHIC-TR-THLC2023-08
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Disease progression-free survival rate

  Disease progression-free survival rate was defined from the start of carbon ion radiotherapy till the date of disease progression at any site or death, or the last follow up.

  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.

• Incidence of Treatment-induced Adverse Events

  Treatment-induced toxicities were scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, for events observed after the first dose of irradiation. Toxicities occurred 90 or more days after the completion of CIRT were defined as late toxicities.

  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 (3)

• Local control rate

  From date of radiotherapy started until the date of first documented local disease progression, assessed up to 100 months.

• Cause-specific survival rate

  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.

• Overall survival rate

  From date of radiotherapy started until the date of death from any cause, assessed up to 100 months.

Study Arms (1)

Study arm

EXPERIMENTAL

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.

Radiation: carbon ion radiotherapy; Other: targeted therapy; Other: single regimen chemotherapy in sequence with radiotherapy

Interventions

carbon ion radiotherapy 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.

Study arm

targeted therapy OTHER

targeted therapy

Study arm

single regimen chemotherapy in sequence with radiotherapy OTHER

single regimen chemotherapy in sequence with radiotherapy

Study arm

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jian Chen: lead

Study Sites (1)

Shanghai Proton and Heavy Ion Center

Shanghai, Shanghai Municipality, 201513, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Radiation Injuries

Interventions

Heavy Ion Radiotherapy; Base Sequence; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Molecular Structure; Biochemical Phenomena; Chemical Phenomena; Genetic Structures; Genetic Phenomena

Study Officials

• Jingfang Mao, PHD

  Shanghai Proton and Heavy Ion Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Li

CONTACT

86-21-38296678; jing.li@sphic.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 9, 2024
• First Posted: March 15, 2024
• Study Start: August 8, 2024
• Primary Completion: June 17, 2025
• Study Completion (Estimated): June 17, 2026
• Last Updated: June 13, 2025

Record last verified: 2025-06

Locations

CN (1)