Particle radiotherapy in early stage non-small cell lung cancer

Completed

• Conditions: on-small cell lung cancer (NSCLC); Cancer; Non-small cell lung cancer (NSCLC)

• Registration Number: ISRCTN78973763
• Lead Sponsor: Shanghai Proton and Heavy Ion Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-07-31
• Study Start: 2018-08-14
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 31

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 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:<br> 1. Treatment-induced side effects and toxicities, assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03<br> 2. Disease response and progression, assessed using the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1<br>

Secondary Outcome Measures

Name	Time	Method
<br> 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<br> 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<br> 3. Local control and various survival rates, calculated using the Kaplan-Meier method<br>