Prospective Study of Quality of Life in Non-small Cell Lung Cancer (NSCLC) Patients Treated With/Without Postoperative Radiotherapy

Non-Small Cell Lung Cancer Clinical Trial

Official title:

Prospective Comparison of Quality of Life and Cardiopulmonary Morbidity After Surgery in Non-small Cell Lung Cancer Patients Treated With and Without Postoperative Radiotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01112631
• Other study ID #: LPSG01
• Status: Completed
• Phase: N/A
• First received: April 27, 2010
• Last updated: September 19, 2011
• Start date: April 2003
• Est. completion date: September 2007

Study information

• Verified date: April 2010
• Source: Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Science and Informatization
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 293
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• complete resection by lobectomy, bi-lobectomy or pneumonectomy of NSCLC,

• pN1 or pN2 disease,

• signed informed consent for participation in the study,

• Karnofsky Performance Status (KPS) higher than 70%.

Exclusion Criteria:

• presence of distant metastases,

• N2 diagnosed before surgery in imaging and/or mediastinoscopy,

• previous radiotherapy to the chest,

• no or inadequate mediastinal nodal dissection ,

• FEV1 after surgery lower than 1.0 liter,

• any active infectious process (including fistula formation) in the chest

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Locations

Country	Name	City	State
Poland	M. Sklodowska-Curie Memorial Cancer Centre	Warsaw

Sponsors (17)

Lead Sponsor

Collaborator

Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology

Cancer Centre in Bydgoszcz, Department of Radiotherapy - Olsztyn, Department of Thoracic Surgery - Lódz, Department of Thoracic Surgery - Otwock, Department of Thoracic Surgery - Wroclaw, Holycross Cancer Center in Kielce, Institute of Tuberculosis and Lung Diseases in Warsaw, Kujawsko-Pomorskie Center of Pulmonology in Bydgoszcz, Lower Silesian Oncology Center - Wroclaw, Medical University of Gdansk, Medical University of Lódz, Regional Cancer Hospital - Szczecin, Regional Specialized Hospital -Checiny, Czerwona Góra, Specialized Hospital in Zdunowo - Szczecin, The Greater Poland Cancer Centre, The Greater Poland Centre of Lung Diseases and Tuberculosis in Poznan

Country where clinical trial is conducted

Poland, 

References & Publications (1)

Kepka L, Bujko K. [Postoperative radiotherapy for non-small cell lung cancer: evidence based data and clinical practice]. Pneumonol Alergol Pol. 2007;75(3):256-61. Review. Polish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary function	All patients had pulmonary function tests (PFT) with Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1) recorded.	One month after surgery and two years after postoperative radiotherapy or surgery alone	Yes
Secondary	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).	One month after surgery and two years after postoperative radiotherapy or surgery alone	Yes