Concurrent and Non-concurrent Chemo-radiotherapy or Radiotherapy Alone With Intensity-modulated Radiotherapy (IMRT) for Non Small Cell Lung Cancer (NSCLC) to an Individualised Mean Lung Dose (MLD)

Study Overview
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Brief Summary
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Our group has shown that increasing the radiation dose to pre-specified normal tissue dose constraints could lead to increased TCP with the same NTCP in patients with non-concurrent and concurrent chemo-radiation. Here, the investigators want to investigate its efficacy in a prospective study in patients with stage I-III NSCLC, who are selected for high-dose radiotherapy with or without chemotherapy, but treated with IMRT. The latter technique has become standard, but the patterns of recurrence and the possibility for dose-escalation in an individualised setting have never been investigated properly.

Detailed Description
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Eligible patients (see below) will receive radiotherapy to the primary tumor and the initially involved mediastinal lymph nodes to an MLD (Mean Lung Dose) of 20 +/-1Gy, irrespective of lung function. Other dose-constraints: spinal cord max: 54Gy, brachial plexus (Dmax):66Gy In concurrence with chemotherapy, radiotherapy will be delivered as follows: First three weeks/30 fractions: twice-daily fractions of 1.5Gy, with 8h to 10h as interfraction interval, 5 days per week. Total dose: 45Gy/30 fractions Thereafter: once daily fractions of 2.0Gy, 5 days per week until the target dose has been reached. In sequential or radiotherapy alone schedules, twice-daily 1.8Gy with an interfraction interval of at least 8h will be delivered. 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 third generation schedule is allowed. The type will be registered. Concurrent part: (day 1 = first day of radiotherapy) cisplatin - vinorelbine cisplatin - docetaxel cisplatin - etoposide cisplatin - pemetrexed in non-squamous histologies Q 3 weeks; 3 cycles When the calculated creatinin clearance is less than 60ml/min, cisplatin may be substituted for carboplatin

Official Title
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Concurrent and Non-concurrent Chemo-radiotherapy or Radiotherapy Alone With IMRT for Stage I-III Non-small Cell Lung Cancer to an Individualised MLD

Conditions
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Stage I-III Non-small Cell Lung Cancer

Intervention / Treatment
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* Radiation: Radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological or cytological proven NSCLC IUCC stage I-III, or solitary metastases (<6), which are amendable for radical local treatment. Performance status 0-2 IMRT technique Exclusion Criteria: Not NSCLC or mixed NSCLC and other histologies (e.g. small cell carcinoma) Stage IV, except for solitary (<6) metastases Performance status 3 or more No IMRT technique

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single group<br> | Radiation: Radiotherapy<br>* Radiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 2.3 and 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 2.3 and 5 years | 
| Dyspnea (CTCAE 4.0) |  | 2.3 and 5 years | 
| Dysphagia (CTCAE 4.0) |  | 2.3 and 5 years | 
| Patterns of recurrence |  | 2.3 and 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiotherapy, NSCLC