To investigate the newly developed method to study lung density changes using CT-scan, in a small patient population. The relationship between radiation induced lung density changes and dose distribution/tumor location will be investigated.
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Density changes measured with serial CT-scans scored using the newly developed
quantification method.
Secondary outcome
. The regional dependency of structural lung damage (tumor location)
. The relationship between lung density changes and dose distribution
. The dynamics of structural lung damage (density changes) in time
Background summary
Radiotherapy is based on reaching the equilibrium between optimal tumor control
and an acceptable chance of radiation induced side effects. In the case of lung
cancer, the prediction of radiation induced lung damage based on physical dose
volume-parameters is limited. Thus, some patients may be undertreated,
receiving lower doses than that they may safely tolerate.
This study aims to investigate the relationship between dose-distrbution and
tumor location on the development of radiation induced changes in lung density.
In the study the newly developed method for quantification of lung density
changes using CT-scans will be used. The acquired data will be incorporated in
the prediction models. If the prediction of radiation induced lung damage can
be improved, a higher dose may be administered to a subset of patients, thus
improving local control and survival with an acceptable chance of toxicity.
Study objective
To investigate the newly developed method to study lung density changes using
CT-scan, in a small patient population.
The relationship between radiation induced lung density changes and dose
distribution/tumor location will be investigated.
Study design
Observational pilot study.
Study burden and risks
Prior to start of radiotherapy, patients will undergo a routine
plannings-CT-scan of the thorax. In case of participation in the study, the
planning-CT-scan is extended with one extra series, i.e. the blank deep
inspiration CT-scan. During follow-up, the research CT-scans consist of a blank
deep inspiration CT-scan of the thorax, 6-26-52 weeks after
(chemo)radiotherapy. These CT-scans will be made at the department of radiation
oncology. The time-points coincide with regular follow-up visits at the
department of radiation oncology. Thus, no extra visits are necessary.
The radiation dose of the 4 CT-scans has been calculated at 40 mSv. This dose
is negligible when compared to the radiotherapy dose given (approximately
45.000-60.000 mSv).
Hanzeplein 1
9700 RB
NL
Hanzeplein 1
9700 RB
NL
Listed location countries
Age
Inclusion criteria
. Age > 18 years
. WHO PS 0-2
. Stage IIIA/IIIB Non Small Cell Lung Cancer (NSCLC). Planned for conventionally fractionated radiotherapy with or without concomitant chemotherapy, 51-60 Gy.
. Limited disease Small Cell Lung Cancer, i.e. tumor confined to hemithorax without evidence of distant metastases or malignant pleural effusion. Planned for conventionally fractionated (chemo)radiotherapy, 45 Gy.
. Adequate pulmonary function
. Life expectancy of at least 6 months
.. Before patient registration, informed consent must be given
Exclusion criteria
. WHO PS=3
. Life expectancy less than 6 months
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 | NL29017.042.09 |