Non-Small Cell Lung CancerNCT01112631
Prospective Study of Quality of Life in Non-small Cell Lung Cancer (NSCLC) Patients Treated With/Without Postoperative Radiotherapy
An observational study of Non-Small Cell Lung Cancer, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- How many people
- 293 participants
- Where
- 1 sitePoland
- Study dates
- Apr 2003to Sep 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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%.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- NSCLC,, PORT,, Quality of Life,, Pulmonary function after RT
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function
All patients had pulmonary function tests (PFT) with Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1) recorded.
Measured: One month after surgery and two years after postoperative radiotherapy or surgery alone
Secondary outcomes (1)
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).
Measured: One month after surgery and two years after postoperative radiotherapy or surgery alone
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startApr 2003
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Tuberculosis and Lung Diseases in Warsaw, The Greater Poland Centre of Lung Diseases and Tuberculosis in Poznan, The Greater Poland Cancer Centre, Cancer Centre in Bydgoszcz, Kujawsko-Pomorskie Center of Pulmonology in Bydgoszcz, Specialized Hospital in Zdunowo - Szczecin, Regional Cancer Hospital - Szczecin, Medical University of Gdansk, 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, Medical University of Łódź
- Investigators
- Krzysztof Bujko, Prof., Principal investigator, Roentgena 5, 02-781 Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112631
- Sponsor's protocol ID
- LPSG01
- Status last verified
- Apr 2010
- First submitted
- 27 Apr 2010
- Last updated
- 20 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 17966101
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01112631
- Acronym / sponsor ID
- LPSG01
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- NSCLC,, PORT,, Quality of Life,, Pulmonary function after RT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of OncologyUniversity, hospital or other
- Collaborators
- Institute of Tuberculosis and Lung Diseases in Warsaw, The Greater Poland Centre of Lung Diseases and Tuberculosis in Poznan, The Greater Poland Cancer Centre, Cancer Centre in Bydgoszcz, Kujawsko-Pomorskie Center of Pulmonology in Bydgoszcz, Specialized Hospital in Zdunowo - Szczecin, Regional Cancer Hospital - Szczecin, Medical University of Gdansk, 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, Medical University of Łódź
- Study start
- Apr 2003
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 28 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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%.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pulmonary function
Time frame: One month after surgery and two years after postoperative radiotherapy or surgery alone
All patients had pulmonary function tests (PFT) with Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1) recorded.
1 secondary outcome
Quality of Life
Time frame: One month after surgery and two years after postoperative radiotherapy or surgery alone
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2011.
- Background: PubMed 17966101Kepka 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krzysztof Bujko, Prof. principal investigator
Roentgena 5, 02-781 Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary function (time frame: One month after surgery and two years after postoperative radiotherapy or surgery alone). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01112631, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2011.