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


N/A
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

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Trial Information

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


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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Pulmonary function

Outcome Description:

All patients had pulmonary function tests (PFT) with Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1) recorded.

Outcome Time Frame:

One month after surgery and two years after postoperative radiotherapy or surgery alone

Safety Issue:

Yes

Principal Investigator

Krzysztof Bujko, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roentgena 5, 02-781 Warsaw, Poland

Authority:

Poland: Ministry of Science and Informatization

Study ID:

LPSG01

NCT ID:

NCT01112631

Start Date:

April 2003

Completion Date:

September 2007

Related Keywords:

  • Non-Small Cell Lung Cancer
  • NSCLC,
  • PORT,
  • Quality of Life,
  • Pulmonary function after RT
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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