An observational study in Non-Small Cell Lung Cancer, sponsored by Maria Sklodowska-Curie National Research Institute of Oncology. Completed at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-09-20.
Sponsored by Maria Sklodowska-Curie National Research Institute of Oncology · Observational
The patients from 12 centers were included into the study. pN2 patients received PORT, pN1 patients did not. PORT was 3D-planned and consisted in 54-56 Gy in 27-28 fractions. One month after surgery, all patients completed EORTC QLQ C-30 questionnaires and had pulmonary function tests (PFT); cardiopulmonary symptoms were assessed by modified LENT-SOM score. Two years after, all patients free of disease repeated the same examinations. Changes in QLQ, LENT-SOM score and the results of PFT were compared for patients receiving and not PORT.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.
This study's enrollment of 293 is above the median of 189 across 1,512 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Maria Sklodowska-Curie National Research Institute of Oncology is the lead sponsor of 63 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
It was assessed that during planned 3 years of accrual approximately 360 stage II patients treated with surgery alone and approximately 240 stage III patients treated with surgery and postoperative radiotherapy (PORT) would enter the study.The higher number of inclusions of pN1 was planned, because of expected higher percentage of cancer related deaths within two years in pN2 patients.
Patients with pN1 disease were followed in the thoracic surgery center and had no PORT. Patients with pN2 disease were referred to PORT.
Exclusion Criteria:
Stage II patients treated with surgery alone
Stage III patients treated with surgery and PORT
Pulmonary function
All patients had pulmonary function tests (PFT) with Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1) recorded.
Time frame: One month after surgery and two years after postoperative radiotherapy or surgery alone
Quality of Life
For quality of life assessment, patients were asked to complete the Quality of Life Questionnaire Core 30 Items (QLC-C30) of the European Organization for Research and Treatment of Cancer (EORTC).
Time frame: One month after surgery and two years after postoperative radiotherapy or surgery alone
This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.
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Maria Sklodowska-Curie National Research Institute of Oncology