|- candidate number||6083|
|- NTR Number||NTR1905|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-jul-2009|
|- Secondary IDs||RT2009-06 |
|- Public Title||Prediction of radiation induced lung damage based on dose distribution and tumour location.|
|- Scientific Title||Prediction of radiation induced lung damage based on dose distribution and tumour location.|
|- hypothesis||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.
|- Healt Condition(s) or Problem(s) studied||Radiotherapy, Lung|
|- Inclusion criteria||1. Age > 18 years;|
2. WHO PS 0-2;
3. Stage IIIA/IIIB Non Small Cell Lung Cancer (NSCLC);
4. Limited disease Small Cell Lung Cancer;
5. Adequate pulmonary lung function;
6. Life expectancy of at least 6 months.
|- Exclusion criteria||1. WHO PS=3;|
2. Life expectancy < 6months.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-sep-2009|
|- planned closingdate||1-sep-2010|
|- Target number of participants||20|
|- Interventions||Research CT-scans are performed prior to and 6, 24, 52 weeks after completion of treatment. This time course covers acute radiation pneumonitis (6-26 weeks after treatment) and the development of radiation induced lung fibrosis (26 weeks and onwards). |
|- Primary outcome||Density changes measured with serial CT-scans scored using the newly developed quantification method.|
|- Secondary outcome||1. The regional dependency of structural lung damage (tumor location);|
2. The relationship between lung density changes and dose distribution;
3. The dynamics of structural lung damage (density changes) in time.
|- Timepoints||Research CT-scans are performed prior to and 6, 24, 52 weeks after completion of treatment.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| |
|- CONTACT for SCIENTIFIC QUERIES|| |
|- Sponsor/Initiator |
(Source(s) of Monetary or Material Support)
|UMC Groningen, Department of radiation oncology|
|- Brief summary||N/A|
|- Main changes (audit trail)|
|- RECORD||10-jul-2009 - 10-okt-2009|