Radiotherapy for NSCLC to a Individualized MLD (BRONC MLD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00573040|
Recruitment Status : Completed
First Posted : December 13, 2007
Last Update Posted : July 21, 2010
|Condition or disease|
|Non-small Cell Lung Cancer|
Eligible patients (see below) will receive radiotherapy to the primary tumor and the initially involved mediastinal lymph nodes to the following MLD (Mean Lung Dose):
- MLD=19 Gy when Fev1 and DLCO > 50% of the predicted value
- MLD=15 Gy when Fev1 and/or DLCO 40-49% of the predicted value
- MLD=10 Gy when Fev1 and/or DLCO <40% of the predicted value
Other dose-constrains: spinal cord max: 54 Gy, brachial plexus (Dmax):66 Gy Minimum tumor dose:79.2 Gy.
Radiotherapy will be delivered in twice-daily fractions of 1.8 Gy with 8 to 10 h as interfraction-interval, 5 days per week.
The radiation doses will be specified according to ICRU 50. Lung density corrections will be applied, as well as all standard QA procedures. Technical requirements are the same as in standard practice at MAASTRO clinic.
|Study Type :||Observational|
|Estimated Enrollment :||180 participants|
|Official Title:||Radiotherapy for Stage I-III Non-small Cell Lung Cancer to an Individualized MLD|
|Study Start Date :||August 2005|
|Actual Study Completion Date :||June 2008|
- death [ Time Frame: 2,3 and 5 years ]
- -progression-free interval -Dyspnea (CTCAE 3.0) -Dysphagia (CTCAE 3.0) -Patterns of recurrence [ Time Frame: 2,3 and 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00573040
|MAASTRO clinic, Maastricht Radiation Oncology|
|Maastricht, Limburg, Netherlands, 6202 AZ|
|Principal Investigator:||Dirk De Ruysscher, MD,PhD||MAASTRO clinic, Maastricht Radiation Oncology|