Plain English Summary
Background and study aims
Lung cancer is the leading cause of cancer-based death worldwide. Approximately 80% of patients with lung cancer are diagnosed with non-small cell lung cancer (NSCLC). Currently, the standard therapy for early stage NSCLC is surgery. However, patients who have chronic lung or heart disease may not be able to endure this surgery. Instead, radiation therapy (RT) has become the first choice of treatment for these patients. Most RT uses photon beams, which deliver high doses of radiation to and affect a larger area of normal organs and tissues, which can lead to damage in these areas.
Particle therapy (PT) is an alternative to RT, which can provide various advantages over RT, including better protection of normal organs and tissues, and better tumor control. Therefore, PT can be used for NSCLC patients with impaired lung or heart function. There are 2 major techniques used for PT, called passive scattering (PS) or pencil-beam scanning (PBS). In theory, PBS provides a better dose distribution of therapy (the spread or distribution of the treatment) than PS. However, PBS has been adopted less quickly as a treatment because of possible dose inaccuracies, due to movement of tumors and surrounding normal tissues. Carbon-ion radiation therapy (CIRT) is a type of PT that uses the PBS technique; however, no patient experiences with using this to treat NSCLC have been reported.
This study aims to report the initial experience with and clinical results of a group of patients with early stage NSCLC treated with CIRT PT using PBS, as part of our work to reduce the impact caused by motion and improve the dose distribution accuracy of PBS PT in patients with lung cancer.
Who can participate?
Adult patients with early stage non-small cell lung cancer (NSCLC) treated with particle therapy in Shanghai Proton and Heavy Ion Center (SPHIC)
What does the study involve?
The toxicity and effectiveness of particle therapy was recorded retrospectively from the records of patient's follow-up period after cancer treatment.
What are the possible benefits and risks of participating?
There is no direct participation required from participants, therefore there are no known benefits or risks of participating in this study.
Where is the study run from?
Shanghai Proton and Heavy Ion Center (SPHIC) (China)
When is the study starting and how long is it expected to run for?
July 2014 to July 2018
Who is funding the study?
1. Shanghai Science and Technology Commission (China)
2. Shanghai Shen Kang Hospital Development Center (China)
3. Shanghai Pudong New Area Technology and Economic Commission (China)
Who is the main contact?
Jingfang Mao
jingfang.mao@sphic.org.cn
Study website
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
171020EXP-01
Study information
Scientific title
Early stage non-small cell lung cancer treated with pencil beam scanning particle therapy: retrospective analysis of early results on safety and efficacy
Acronym
Study hypothesis
Particle therapy should be effective and safe in treating early stage non-small cell lung cancer based on its dosimetric and radio-biologic advantages.
Ethics approval(s)
Institutional Research Board (IRB) of the Shanghai Proton and Heavy Ion Center (SPHIC), 27/10/2017, 171020EXP-01
Study design
Observational single-center retrospective study
Primary study design
Observational
Secondary study design
Case series
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
No participant information sheet available
Condition
Non-small cell lung cancer (NSCLC)
Intervention
All patients were evaluated weekly for treatment-induced toxicities and disease response/progression during their treatment. After the completion of RT, all patients are required to be evaluated according to our institutional follow-up protocol for lung cancer at 3 months after the 1st day of RT, every 3-4 months within the first 2 years, every 6 months between year 3 and 5, and annually thereafter. Treatment-induced side effects 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 PRT were defined as late toxicities. All the toxicities were recorded prospectively.
The overall survival (OS) time was calculated from the date of pathological diagnosis of the primary disease or radiological diagnosis of disease for patients without pathological confirmation until death or the date of the last follow-up. The time to local, regional, or distant failure was calculated from the date of the first fraction of PT until documented first considered treatment failure. Local control and various survival rates were calculated using the Kaplan-Meier method.
Intervention type
Device
Pharmaceutical study type(s)
Phase
Drug/device/biological/vaccine name(s)
Primary outcome measure
The following were assessed at 3 months after the first day of treatment, then every 3-4 months within the first 2 years, then every 6 months for years 3-5, and annually thereafter:
1. Treatment-induced side effects and toxicities, assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
2. Disease response and progression, assessed using the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1
Secondary outcome measures
1. Overall survival time, calculated from the date of pathological diagnosis of the primary disease, or radiological diagnosis of disease for patients without pathological confirmation, until death or the date of the last follow-up
2. TIme to local, regional, or distant failure, calculated from the date of the first fraction of particle therapy until the documented first considered treatment failure
3. Local control and various survival rates, calculated using the Kaplan-Meier method
Overall study start date
01/07/2014
Overall study end date
31/07/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Non-small cell lung cancer (NSCLC):
1.1. According to the following criteria of the American Association of Cancer staging version 7:
1.1.1. T1-2 (T1 indicates that the cancer is contained within the lungs and T2 indicates that either the cancer is 3-5 cm in size, or any of the following: the cancer involves the main airway but is not close to where the bronchus divides, the cancer involves the inner lining of the chest cavity, or that part/all of the lung has collapsed or is blocked)
1.1.2. N0-1 (N0 indicates no spread to lymph nodes, N1 indicates there are cancer cells in the lymph nodes)
1.1.3. M0 (no distant cancer spread found)
1.2. Medically inoperable or declined surgery
2. Longest diameters of primary tumour and hilar lymph node <5 cm
3. Pathologically confirmed NSCLC or clinically diagnosed as NSCLC with the Fluorodeoxyglucose-Positron Emission Tomography/Computed Tomography (FDG-PET/CT) avid lung lesion
4. Diagnosed with NSCLC with CT scans by 2 senior radiologists independently
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
31
Participant exclusion criteria
1. Locally advanced or metastastic NSCLC at diagnosis
2. Previously received radiotherapy
3. Younger than 14 years of age
4. No signed informed consent
Recruitment start date
01/08/2014
Recruitment end date
31/03/2018
Locations
Countries of recruitment
China
Study participating centre
Shanghai proton and heavy ion center
4365 Kang Xing Road
Shanghai
201321
China
Sponsor information
Organisation
Shanghai Proton and Heavy Ion Center
Sponsor details
4365 Kang Xing Road
Shanghai
201321
China
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Not defined
Funder name
Shanghai Science and Technology Commission
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Shanghai Shen Kang Hospital Development Center
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Shanghai Pudong New Area Technology and Economic Commission
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We are intending to publish a research article in the second half of 2018.
Intention to publish date
30/09/2018
Individual participant data (IPD) sharing plan
The datasets generated during and/or analysed during the current study are not expected to be made available due to privacy protection.
IPD sharing plan summary
Not expected to be made available
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 25/01/2019 | Yes | No |