Particle radiotherapy in early stage non-small cell lung cancer
| ISRCTN | ISRCTN78973763 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78973763 |
| Protocol serial number | 171020EXP-01 |
| Sponsor | Shanghai Proton and Heavy Ion Center |
| Funders | Shanghai Science and Technology Commission, Shanghai Shen Kang Hospital Development Center , Shanghai Pudong New Area Technology and Economic Commission |
- Submission date
- 10/08/2018
- Registration date
- 14/08/2018
- Last edited
- 29/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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
Contact information
Scientific
4365 Kang Xing Road
Shanghai
201321
China
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational single-center retrospective study |
| Secondary study design | Case series |
| Study type | Participant information sheet |
| 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 |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
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: |
| Key secondary outcome measure(s) |
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 |
| Completion date | 31/07/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 31 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/08/2014 |
| Date of final enrolment | 31/03/2018 |
Locations
Countries of recruitment
- China
Study participating centre
Shanghai
201321
China
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 25/01/2019 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
29/01/2019: Publication reference added,
