NCT01112631

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
293

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 28, 2010

Completed
Last Updated

September 20, 2011

Status Verified

April 1, 2010

Enrollment Period

4.4 years

First QC Date

April 27, 2010

Last Update Submit

September 19, 2011

Conditions

Non-Small Cell Lung Cancer

Keywords

NSCLC,PORT,Quality of Life,Pulmonary function after RT

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Quality of Life

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

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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%.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M. Sklodowska-Curie Memorial Cancer Centre

Warsaw, 02-781, Poland

Location

Related 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. Polish.

    PMID: 17966101BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Krzysztof Bujko, Prof.

    Roentgena 5, 02-781 Warsaw, Poland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 27, 2010

First Posted

April 28, 2010

Study Start

April 1, 2003

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

September 20, 2011

Record last verified: 2010-04

Locations

PL(1)