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Carbon Ion Therapy for Peripheral Non-small Cell Lung Cancer

Primary Purpose

Non-small Cell Lung Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Carbon ion beam radiotherapy
Sponsored by
Shanghai Proton and Heavy Ion Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Between the ages of 18 and 80. ECOG general status score of 0-2 . Primary non-small cell lung cancer (NSCLC) confirmed by histology or cytological pathology, T1-2N0M0, stage Ia-IIa (AJCC/UICC 8th edition). 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). 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 the informed consent. Exclusion Criteria: Multiple primary tumors. Patient fails to comply with the treatment protocol. 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. Pregnancy (confirmed by serum or urine β-HCG test) or lactation period. 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.

Sites / Locations

  • Shanghai Proton and Heavy Ion CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study arm

Arm Description

patients received carbon ion radiotherapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

local control rate
local control rate was defined was defined from the start of carbon ion radiotherapy till the date of local failure or the last follow-up
overall survival rate
overall survival rate was defined from the start of carbon ion radiotherapy till the date of death or the last follow-up
Incidence of Treatment-induced Adverse Events [Safety and Tolerability]
Treatment-induced toxicities were scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, 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.

Full Information

First Posted
October 26, 2022
Last Updated
November 10, 2022
Sponsor
Shanghai Proton and Heavy Ion Center
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1. Study Identification

Unique Protocol Identification Number
NCT05613452
Brief Title
Carbon Ion Therapy for Peripheral Non-small Cell Lung Cancer
Official Title
Prospective Phase II Clinical Study of Carbon Ion Beam Stereotactic Radiotherapy for Peripheral Type Early-stage Non-small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2022 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Proton and Heavy Ion Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study arm
Arm Type
Experimental
Arm Description
patients received carbon ion radiotherapy
Intervention Type
Radiation
Intervention Name(s)
Carbon ion beam radiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
disease progression-free survival rate
Description
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.
Time Frame
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
Secondary Outcome Measure Information:
Title
local control rate
Description
local control rate was defined was defined from the start of carbon ion radiotherapy till the date of local failure or the last follow-up
Time Frame
From date of radiotherapy started until the date of first documented local disease progression, assessed up to 100 months
Title
overall survival rate
Description
overall survival rate was defined from the start of carbon ion radiotherapy till the date of death or the last follow-up
Time Frame
From date of radiotherapy started until the date of death from any cause, assessed up to 100 months
Title
Incidence of Treatment-induced Adverse Events [Safety and Tolerability]
Description
Treatment-induced toxicities were scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, 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.
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Between the ages of 18 and 80. ECOG general status score of 0-2 . Primary non-small cell lung cancer (NSCLC) confirmed by histology or cytological pathology, T1-2N0M0, stage Ia-IIa (AJCC/UICC 8th edition). 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). 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 the informed consent. Exclusion Criteria: Multiple primary tumors. Patient fails to comply with the treatment protocol. 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. Pregnancy (confirmed by serum or urine β-HCG test) or lactation period. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Li
Phone
86-21-38296678
Email
jing.li@sphic.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jingfang Mao, PHD
Organizational Affiliation
Shanghai Proton and Heavy Ion Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Proton and Heavy Ion Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201513
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Li
Phone
86-21-38296678
Email
jing.li@sphic.org.cn
First Name & Middle Initial & Last Name & Degree
Kun Liu
Phone
86-21-38296678
Email
kun.liu@sphic.org.cn
First Name & Middle Initial & Last Name & Degree
Jingfang Mao, PHD
First Name & Middle Initial & Last Name & Degree
Kai-liang Wu, PHD
First Name & Middle Initial & Last Name & Degree
Jian Chen, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Carbon Ion Therapy for Peripheral Non-small Cell Lung Cancer

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