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

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

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.

Study Overview

• Status: Completed
• Conditions: Non-Small Cell Lung Cancer

• Study Type: Observational
• Enrollment (Actual): 293

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 02-781
    • M. Sklodowska-Curie Memorial Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Stage II patients post surgery; Stage II patients treated with surgery alone
Stage III patients post surgery; Stage III patients treated with surgery and PORT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
• Collaborators: Medical University of Gdansk; The Greater Poland Cancer Centre; Medical University of Łódź; Institute of Tuberculosis and Lung Diseases in Warsaw; The Greater Poland Centre of Lung Diseases and Tuberculosis in Poznan; Cancer Centre in Bydgoszcz; Kujawsko-Pomorskie Center of Pulmonology in Bydgoszcz; Specialized Hospital in Zdunowo - Szczecin; Regional Cancer Hospital - Szczecin; Holycross Cancer Center in Kielce; Department of Thoracic Surgery - Wrocław; Department of Radiotherapy - Olsztyn; Department of Thoracic Surgery - Łódź; Lower Silesian Oncology Center - Wroclaw; Regional Specialized Hospital -Chęciny, Czerwona Góra; Department of Thoracic Surgery - Otwock

Publications and helpful links

General Publications

• 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. Polish.

Study record dates

Study Major Dates

• Study Start: April 1, 2003
• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: April 27, 2010
• First Submitted That Met QC Criteria: April 27, 2010
• First Posted (Estimate): April 28, 2010

Study Record Updates

• Last Update Posted (Estimate): September 20, 2011
• Last Update Submitted That Met QC Criteria: September 19, 2011
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: NSCLC,; Quality of Life,; PORT,; Pulmonary function after RT
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: LPSG01