The aim of the study is to evaluate the change of lung function at least one year after definitive chemoradiation (concurrent or sequential) or radiotherapy alone in patients with locally advanced (non) small cell lung carcinoma to assess late…
ID
Source
Brief title
Condition
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in FEV1 and DLCO >1 year after treatment with radiotherapy or
combination treatment with chemoradiotherap either concurrent or sequential.
Secondary outcome
Not applicable
Background summary
Radiation induced lung injury is common in patients receiving thoracic
radiotherapy. Radiotherapy-induced pulmonary symptoms (shortness of breath and
cough) occur in approximately 5-20% of patients irradiated for breast cancer,
lymphoma or lung cancer. 50-90% of these patients have declines in pulmonary
function tests (PFTs)
Radiation induced lung injury can be divided in early injury (3- 6 months after
treatment), most of the time radiation pneumonitis and late injury (from 1 year
after treatment, chronic fibrosis). Previous studies show the first decline in
PFT in 6 months and further decline beyond 1 year (3, 4). During treatment
with (chemo) radiation there is no change in PFT
The change in pulmonary function is dependent on the mean lung dose and
pre-existing lung disease. Concurrent chemotherapy has an additional negative
effect on pulmonary function. From previous studies in breast cancer en
lymphoma it is known that the changes in PFT values can be estimated before
treatment.
Study objective
The aim of the study is to evaluate the change of lung function at least one
year after definitive chemoradiation (concurrent or sequential) or radiotherapy
alone in patients with locally advanced (non) small cell lung carcinoma to
assess late radiation injury in our patient population (patients treated in a
large non academic teaching hospital). Our aim is to see if our results match
the results found in literature.
Study design
Retrospective selection of patients with prospective analysis of pulmonary
function changes.The setting of this study is the pulmonary function
laboratory, part of the Pulmonology Department, Haga Teaching Hospital, The
Hague, The Netherlands. The study will start December 2016. At the latest it
will end in March 2017
Study burden and risks
Burden: an extra visit to the oupatient clinic. This will take 60 minutes
including medical history and pulmonary function testing wit finger prick.
Risks: none
Els Borst-Eiulersplein 275
Den haag 2545 AA
NL
Els Borst-Eiulersplein 275
Den haag 2545 AA
NL
Age
Inclusion criteria
1.* 18 years of age
2.Histologically of cytologically confirmed diagnosis of (N)SCLC
3.Stage II/III non operable disease
4.Treatment with definite concurrent of sequential chemoradiation between November 2010 and November 2015
5.Lung function testing including DLCO measurement pre-treatment is available
6.Signed written informed consent
Exclusion criteria
Not being able to have another lung function test done (due to death or poor condition)
Design
Recruitment
metc-ldd@lumc.nl
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 | NL60077.098.16 |