Concurrent Chemo-radiation Form NSCLC to a Individualized MLD

Study Overview
=================
Brief Summary
-----------------
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 patients with non-concurrent chemo-radiation. In a subsequent phase I trial, in patients receiving non-concurrent chemo-radiation we showed the safety of this approach. Here,we want to investigate its efficacy in a prospective study in patients with stage III NSCLC, who are selected for radical concurrent radiotherapy

Detailed Description
-----------------
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

Official Title
-----------------
Concurrent Chemo-radiotherapy for Stage III Non-small Cell Lung Cancer ta an Individualized MLD

Conditions
-----------------
Non-small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological or cytological proven NSCLC UICC stage I-III Performance status 0-2 FeV 1 and DLCO at least 30% of the age-predicted value Exclusion Criteria: Not NSCLC or mixed NSCLC and other histologies (e.g. small cell carcinoma) UICC stage IV Performance status 3 or more FeV 1 and DLCO < 30% of the age-predicted value

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Inclusion criteria Histological or cytological proven NSCLC UICC stage I-III Performance status 0-2 FeV1 and DLCO at least 30% of age-predicted value Exclusion criteria: Not NSCLC or mixed NSCLC and other histologies (e.g. small cell carcinoma) stage IV performance status 3 or more FeV 1 or DLCO< 30% of the age-predicted value | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death |  | 2,3 and 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| -progression-free interval -Dyspnea (CTCAE 3.0) -Dysphagia (CTCAE 3.0) -Patterns of recurrence |  | 2,3 and 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radiotherapy, NSCLC, stage III non-small cell lung cancer