Radiotherapy Planning Based on Positron Emission Tomography With Fluoro-deoxyglucose For Advanced NSCLC

Study Overview
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Brief Summary
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Simultaneous radio-chemotherapy in advanced non-small cell lung cancer. The study focusses on a randomised comparison of conventional radiotherapy planning with irradiation of macroscopic tumor and lymph nodes together with prophylactic target volumes vs. irradiation only of FDG-positive lesions. Primary endpoint is the local disease control in the chest.

Detailed Description
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Simultaneous radio-chemotherapy in advanced non-small cell lung cancer. The study focusses on a randomised comparison of conventional radiotherapy planning with irradiation of macroscopic tumor and lymph nodes together with prophylactic target volumes vs. irradiation only of FDG-positive lesions. Primary endpoint is the local disease control in the chest

Official Title
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Optimisation of Radiotherapy-Planning in Patients With Inoperable Locally Advanced Non-Small-Cell Lung Cancer by FDG-PET

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Procedure: restriction of radiotherapy to FDG-PET positive areas only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically proved NSCLC UICC-stage I-III, no resection planned complete staging < 6 wks before treatment including cranial CT ECOG <3, Karnofsky-Index >60% age > 18 < FEV1 > 1,0 l or >35% RT-planning according to protocol feasible chemotherapy feasible written informed consent Exclusion Criteria: neuroendocrine tumors, plain broncho-alveolar-cell ca. distant metastases, supraclavicular lymph node metastases malignant pleural effusion resection of actual tumor performed inclusion in other study protocol chemotherapy due to actual tumor before FDG-PET induction-chemotherapy acute vena cava superior syndrome second malignancy other than basalioma pregnancy, lactation heart insufficiency NYHA III/IV pneumoconiosis with active inflammatory changes of mediastinal lymph nodes acute broncho-pulmonary infection at time of PET-examination

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 |
| --- | --- |
| No Intervention: A<br>Irradiation of all tumor manifestations detectable by CT and/or positron emission tomography using fluoro-deoxy-glucose including a part of eventual atelectasis and the whole affected lymph node stations by 60 - 74 Gy/2Gy) irradiation of elective lymph node stations up to 50 Gy/2 Gy | |
| Experimental: B<br>Irradiation of all tumor manifestations detectable by positron emission tomography using fluoro-deoxy-glucose including the whole affected lymph node stations by 60 - 74 Gy/2Gy | Procedure: restriction of radiotherapy to FDG-PET positive areas only<br>* Restriction of target volumes to areas positive in positron emission tomography using fluoro-deoxy-glucose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to local progression | Time from randomization to first evidence of local progression or last follow up | actuarial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Time from randomization to death or last follow up | actuarial | 
| normal tissue toxicity | Time from randomization to death or last follow up | actuarial | 
| in and out field progression | Time from randomization to progression or last follow up | actuarial | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, FDG-PET, Radiotherapy, planning, target volumes