PRIMARY OBJECTIVE1. To assess the effect of screening with AFB and subsequent treatment of endobronchial lesions in addition to screening with CT scan on cancer free survival of COPD patients previously treated for early stage NSCLC. SECONDARY…
ID
Source
Brief title
Condition
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Five-year cancer free survival
Secondary outcome
Overall five-year survival
Quality of life
Cost-effectiveness
Background summary
Patients treated for early stage lung cancer with curative intent are at risk
for subsequent primary lung cancer(s). At present there is no international
consensus on the follow-up of these patients. Sensitive methods for the early
detection of lung cancer such as CT scan and autofluorescence bronchoscopy are
currently available and primary screening trials are ongoing. It is unknown
whether autofluorescence bronchoscopy (AFB) is accurate and cost-effective in
secondary screening and whether early detection and treatment of subsequent
endobronchial primary lung cancer(s) improves patient survival.
Study objective
PRIMARY OBJECTIVE
1. To assess the effect of screening with AFB and subsequent treatment of
endobronchial lesions in addition to screening with CT scan on cancer free
survival of COPD patients previously treated for early stage NSCLC.
SECONDARY OBJECTIVES
1. To assess the incidence and progression rate of endobronchial
(pre-)malignant lesions in high-risk patients.
2. To assess the effect of screening with AFB and subsequent treatment of
endobronchial lesions in addition to screening with CT scan on overall survival
and quality of life of COPD patients previously treated for early stage NSCLC.
3. To investigate the cost-effectiveness of screening with AFB in addition to
CT scan in COPD patients previously treated for early stage NSCLC.
Study design
Randomized, open trial
Intervention
Screening with autofluorescence bronchoscopy and direct treatment in case of
detection.
Study burden and risks
The burden in the intervention group consists of annual
autofluorescencebronchoscopy and treatment in case of detection of a
(pre-)malignant lesion. The risks (complications) of bronchoscopy and local
endobronchial treatment are low (<1%). The endobronchial treatment might
prolong cancer free and overall survival in the intervention arm.
De Boelelaan 1117
1081 HV Amsterdam
NL
De Boelelaan 1117
1081 HV Amsterdam
NL
Listed location countries
Age
Inclusion criteria
T1N0M0 or T2aN0M0 histologically proven NSCLC with a maximum tumor diameter of 4cm, treated with either anatomical surgical resection or SBRT with curative intent within the last six months. T descriptors according to the 7th edition of the TNM classification for lung cancer. ;GOLD II-IV COPD prior to resection.10
Exclusion criteria
Adjuvant chemo-, immune- or radiotherapy
Current or recent (<5 years) cancer other than lung cancer.
Chronic respiratory failure, defined as PaO2 <60 mmHg with or without PaCO2 >50 mmHg.10
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL36480.029.11 |