Condition category
Cancer
Date applied
10/08/2018
Date assigned
14/08/2018
Last edited
29/01/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jingfang Mao

ORCID ID

Contact details

4365 Kang Xing Road
Shanghai
201321
China

Additional identifiers

EudraCT 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

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

Trial setting

Hospitals

Trial 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

Phase

Drug names

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 trial start date

01/07/2014

Overall trial 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

Patient

Age group

Adult

Gender

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

Trial 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

http://www.sphic.org.cn

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.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to privacy protection.

Intention to publish date

30/09/2018

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30683133

Publication citations

Additional files

Editorial Notes

29/01/2019: Publication reference added,