Non-small cell lung cancer (NSCLC) Cancer Non-small cell lung cancer (NSCLC)
Conditions
Interventions
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 accor
Sponsors
Shanghai Proton and Heavy Ion Center
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
China
Outcome results
None listed