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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

293 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-04-30

Study Completion Date

2007-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-Small Cell Lung Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Stage II patients post surgery

Stage II patients treated with surgery alone

No interventions assigned to this group

Stage III patients post surgery

Stage III patients treated with surgery and PORT

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No