Novel Approach to Radiotherapy in Locally Advanced Lung Cancer Concomitant Navelbine®

Study Overview
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Brief Summary
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To investigate the effect of escalation of radiation dose to tumor and lymph nodes based on an inhomogeneous dose distribution controlled by FDG-PET positive areas compared to a standard homogeneous dose spread

Detailed Description
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To investigate the effect of escalation of radiation dose to tumor and lymph nodes based on an inhomogeneous dose distribution controlled by FDG-PET-positive areas compared to a standard homogeneous dose spread.

Official Title
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Novel Approach to Radiotherapy in Locally Advanced Lung Cancer - Heterogeneous FDG-guided Dose Escalation With Concomitant Navelbine®

Conditions
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NSCLC

Intervention / Treatment
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* Radiation: Escalated: Inhomogeneous dose plan
* Radiation: Standard: Homogeneous dose plan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with histologically or cytologically proven locally advanced NSCLC stage IIB to IIIB Performance status 0-1 Able to comply with treatment and follow study and follow-up procedures Women must have negative pregnancy test Signed, informed consent Plan for radiotherapy with conventional 66 Gy/ 33 F, which meets all dosing limits two normal tissue must be available Exclusion Criteria: Any unstable systemic disorder (including infection , unstable angina, congestive heart failure , severe liver , kidney or metabolic disease) Need for nasal oxygen Former thoracic radiotherapy, unless there is no significant overlap with previous fields Any other active malignant disease Unable to take oral medications or needing intravenous nutrition Ulcer Nursing women

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard: Homogeneous dose plan<br>Treatment will be given over 33 treatments. The dose is 66 Gy. | Radiation: Standard: Homogeneous dose plan<br> <br> |
| Experimental: Escalation: Inhomogeneous dose plan<br>Radiation dose is increased to tumor and lymph nodes based on an inhomogeneous dose distribution determined by the most active ( FDG-PET criteria ) area of the node compared to a standard uniform dose distribution. Treatment will be given over 33 treatments. The dose is as high as possible taking the tolerance of the normal tissue into consideration | Radiation: Escalated: Inhomogeneous dose plan<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Locoregional control (Tumor recurrency is assessed by scheduled CT (of the thorax and upper abdomen) | Tumor recurrency is assessed by scheduled CT (of the thorax and upper abdomen ) every 3 months combined with PET/CT every 9 months or if occurrence is clinically suspected. Suspicion of tumor relapse local, regional or distant should be verified by biopsy. Date of detected recurrence is the date of the imaging modality suspecting relapse. The patient will be censured at death without local relapse. | 5-7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity (graded after CTCAE 4.0 assessed by physician) | Acute and late toxicity graded after CTCAE 4.0 assessed by physician at scheduled follow-up visits | 10 years | 
| Survival | Time from randomization to exact date of death of any cause. | 15 years | 
| Progression free survival | Time from randomization to date of progression, death, or occurence of metastatic disease | 15 years |