Radiotherapy for NSCLC to a Individualized MLD (BRONC MLD)
Our group has shown in a modeling study that increasing the radiation dose to pre-specified normal tissue dose constrains could lead to increased TCP with the same NTCP. In a subsequent phase I trial, the investigators showed the safety of this approach. Here, the investigators want to investigate its efficacy in a prospective study in patients with stage I-III NSCLC, who are selected for radical radiotherapy
Non-small Cell Lung Cancer
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Radiotherapy for Stage I-III Non-small Cell Lung Cancer to an Individualized MLD|
- death [ Time Frame: 2,3 and 5 years ] [ Designated as safety issue: No ]
- -progression-free interval -Dyspnea (CTCAE 3.0) -Dysphagia (CTCAE 3.0) -Patterns of recurrence [ Time Frame: 2,3 and 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||August 2005|
|Study Completion Date:||June 2008|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00573040
|MAASTRO clinic, Maastricht Radiation Oncology|
|Maastricht, Limburg, Netherlands, 6202 AZ|
|Principal Investigator:||Dirk De Ruysscher, MD,PhD||MAASTRO clinic, Maastricht Radiation Oncology|