Primary Outcome Measures:
- death [ Time Frame: 2,3 and 5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- -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 ]
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:54 Gy. Maximal tumor dose:69 Gy
Radiotherapy will be delivered as follows:
- First 3 weeks: 30 fractions: twice-daily fractions of 1.5 Gy, with 8 to 10 h as interfraction-interval, 5 days per week Total dose;45Gy/30 fractions
- Thereafter: once-daily fractions of 2.0 Gy, 5 days per week until the target dose has been reached.
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.
Chemotherapy schedules allowed:
- 1-2 cycles induction chemotherapy; any type will be registered.
concurrent part:(day1= first day of radiotherapy)
cisplatin - vinorelbine
- Cisplatin 50 mg/m2 day 2 and day 9
- Vinorelbine 20 mg/m2 day 2 and day 9
- Cisplatin 40mg/m2 day 23
- Vinorelbine 15mg/m2 day 23 and day 30
cisplatin - docetaxel
- Cisplatin 50 mg/m2 day 2,9 and 29
- Docetaxel 20 mg/m2 day 2, 9, 16, 23 and 29
cisplatin - etoposide
- Cisplatin 60 mg/m2 day 1
- Docetaxel 120 mg/m2 day 1-3
Q 3 weeks, 3 cycles
When the calculated creatinin clearance is less than 60 ml/min, cisplatin may be substituted for carboplatin
Purpose
