Study of the Decrease of Length of Stereotactic Body Radiation Therapy in Lung Cancer

Study Overview
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Brief Summary
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Purpose : Non small cell lung cancer (NSCLC) is among the most common cancers in the werstern world. Patients with stage I have the most satisfactory outcomes. The gold standard for treatment is still surgery, but this approach has recently been challenged by hypofractionnated stereotactic body radiation therapy (SBRT). Therefore, for patients who are not eligible for surgery due to their significant co-morbidity, or for those who refuse surgical resection, stereotactic radiotherapy is an efficient practical alternative. SBRT is well tolerated and efficient, in fact local control rate at 3 years reaches more than 90%. Most of guidelines recommand a dose between 48 and 60 Gy delivered in 3 at 8 fractions and 3 weeks. Biological effect depends on the dose distribution in time and decreases when the number of fractions or length of radiation treatment increase. Decreasing the length of treatment and the interval between fractions may improve efficiency of treatment and local control rate. Moreover, it may improve quality of life of patients. Nevertheless, an evaluation of safety of such shorter treatment course, with a phase I-II clinical study is needed.

Detailed Description
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Intervention : Stereotactic Body Radiation Therapy in the treatment of stage IA - IB non small cell lung cancer (T1N0M0 or T2aN0M0) Study type : Interventional Study design : Endpoint classification : safety/efficacy study Intervention model : single group assignment Masking : open label Primary purpose : treatment

Official Title
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Phase I/II Study of the Decrease of Length of Stereotactic Body Radiation Therapy in the Treatment of Stage IA - IB Non Small Cell Lung Cancer (T1N0M0 or T2aN0M0)

Conditions
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Stage IA - IB Non Small Cell Lung Cancer

Intervention / Treatment
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* Radiation: stereotactic radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologic or cytologic diagnosis of non small cell lung cancer stage IA-IB (T1N0M0 or T2aN0M0) None histologic or cytologic diagnosis of non small cell lung cancer stage IA-IB (T1N0M0 or T2aN0M0) with evolutionary criteria (increase on two successive CT scan and pathological hyperfixation in the TEP scan) Resectable tumor but patient unfit for surgical resection Resectable tumor but patient refusing surgical resection KPS > 60% Pulmonary functions: FEV > 40% theoric value, PO2 ≥ 70mmHg, PCO2 < 50mmHg Patient who can hold appropriate immobilization in dorsal decubitus during approximately 30 minutes Age 18 years or older Not affected by a mental disease Understanding and be informed of the investigational nature of this study and must give written consent prior to the receiving of treatment per this protocol Inscription at the French Social Security Exclusion Criteria: Patient pregnant Patient deprived of freedom or under guardianship Pulmonary functions : FEV < 40% theoric value, PO2 ≤ 70mmHg, PCO2 > 50mmHg Prior thoracic radiation treatment Prior radiation pneumonitis

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: stereotactic<br> | Radiation: stereotactic radiotherapy<br>* first level : W1 : 3 fractions - W2 : 2 fractions - W3 : 3 fractions second level : W1 3 fractions - W2 : 3 fractions - W3 : 3 fractions Third level : W1 : 4 fractions - W2 : 2 fractions - W3 : 2 fractions Fourth level : W1 : 4 fractions - W2 : 4 fractions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal tolerated length of treatment of Stereotactic Body Radiation Therapy in the treatment of stage IA - IB non small cell lung cancer (T1N0M0 or T2aN0M0) | The minimal tolerated length of treatment level is determined according to a 3x3 modified Fibonacci method and 4 schedule levels will be explored. The dose of radiation is 60 Gy in 8 fractions of 7,5 Gy. The first treatment schedule level consists of delivering 3 fractions the first week, 2 fractions the second week and 3 fractions the third week. The second treatment schedule level consists of delivering 3 fractions the first week, 3 fractions the second week and 2 fractions the third week. The third treatment schedule level consists of delivering 4 fractions the first week, 2 fractions the second week and 2 fractions the third week. Finally, the fourth treatment schedule level consists of delivering 4 fractions the first week and 4 fractions the second week (duration of the treatment : 2weeks). | 22 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 22 months |