Predictive Value of FDG-TEP During Radiotherapy or Chemo-radiotherapy in Patients With NCSC on the One-year Survival

Study Overview
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Brief Summary
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The poor prognosis in the early-stage of lung cancer is due to potential worsening of the disease (local relapse, metastasis), to insufficient efficacy and toxicity of actual treatments. FDG-PET is a medical imaging modality allowing the quantification of the tumour glucose consumption. Then, this exam is used for pathology staging, target volume definition for RT, and treatment efficiency few months after RT or CRT. Our assumption is that an FDG-PET exam during the course of the RT or CRT might be predictive of the treatment efficiency few months later. In this study, the investigators propose to perform 4 FDG-PET: first PET1 before radiotherapy, second PET2 during the radiotherapy (see RTEP1), third and fourth PET3 PET4 3month and 12 month after the therapy. The investigators will investigate the performances of FDG-PET performed during the RT or CRT for the prediction of the one-year patient heath outcome. If the predictive value of TEP2 is confirmed, the investigators would be able to optimize the planning treatment during the course of the therapy.

Official Title
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Predictive Value of FDG-TEP During Radiotherapy (RT) or Chemo-radiotherapy (CRT) in Patients With Non Small Cell Lung Cancer on the One-year Survival

Conditions
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Lung Cancer, NSCLC

Intervention / Treatment
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* Procedure: Positron Emission Tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed non-small cell lung cancer Fertile patients must use effective contraception WHO performance status <2 Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (≥ 10 mm with spiral CT scan) Exclusion Criteria: Pregnant or lactating females Baseline fludeoxyglucose F 18 (FDG)-positron emission tomography (PET) scan without any target lesion Unable to under PET CT evaluation other concurrent investigational agents No Planning to undergo curative intent radiotherapy familial, social, geographic, or psychological conditions that would preclude study participation Prior malignancy progressive disease

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Patients treated with curative and exclusive radiotherapy (60 Gy minimum), with possibly prior chemotherapy | Procedure: Positron Emission Tomography<br>* Positron Emission Tomography<br>* Other names: PET scan;|
| Other: 2<br>Patient treated with concomitant chemotherapy and radiotherapy (60 Gy minimum), with possibly prior chemotherapy chemotherapy Treatment | Procedure: Positron Emission Tomography<br>* Positron Emission Tomography<br>* Other names: PET scan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SUV max from FDG PETScan | Measure of FDG-TEP uptake variation (SUV max) to assess predictive value of FDG-TEP during radiotherapy | Baseline - 5 Weeks after begining of radiotherapy- 3 months after end of radiotherapy- 1 year afterwards | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study of several optimized radiotherapy scenary according to the quantification of the tumour glucose consumption during radiotherapy |  | after the completion enrollment date | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Positron-Emission Tomography, PET Scan, Non-Small-Cell Lung Carcinoma, Radiation Oncology, SUV