Stereotactic Precision And Conventional Radiotherapy Evaluation

Study Overview
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Brief Summary
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A randomized phase II study for medically inoperable stage I non-small cell lung cancer where stereotactic body radiotherapy in three fractions to 66 Gy is compared with conventionally fractionated radiotherapy to 70 Gy in 35 fractions.

Detailed Description
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This is a multicenter Scandinavian randomized phase II study of stereotactic hypofractionated radiotherapy with body frame versus conventionally fractionated radiotherapy for stage I medically inoperable non-small cell lung cancer patients. There is a 1:1 randomization between arm A: Stereotactic radiotherapy to a dose of 66 Gy with 22 Gy per fraction at the isocenter (45 Gy covers the PTV) in 3 fractions during one week with body frame fixation and a planning target volume with a 5 mm margin around the macroscopic tumour, and arm B: Conventionally fractionated radiotherapy to a dose of 70 Gy with 2 Gy per fraction in 35 fractions during 7 weeks with fixation in a vacuum pillow and a planning target volume with a 2 cm margin around the macroscopic tumour.

Official Title
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A Multicenter Randomized Phase II Study of Stereotactic Hypofractionated Radiotherapy With Body Frame Versus Conventionally Fractionated Radiotherapy for Stage I Medically Inoperable Non-small Cell Lung Cancer

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Radiation: Stereotactic radiotherapy
* Radiation: Conventionally fractionated radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-small cell lung cancer stage I: T1-2 N0 M0. Medically inoperable patients or patients refusing surgery. Morphologically verified. If that is impossible there must be increased tumour size in repeated CT scans and positive PET. Patients should have a life expectancy of > 6 months. WHO performance status 0-2. Signed written informed consent obtained. Patient should be feasible for both study arms. Exclusion Criteria: Patients with central tumour growth adjacent to trachea, main bronchus or esophagus. Maximal tumour diameter > 6 cm. Patients with prior malignancy within the last five years (except basal cell carcinoma of the skin or in situ carcinoma of the cervix). Any prior antitumoral treatment of the present lung cancer. Previous irradiation that included part of the lung. Pregnant women.

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 |
| --- | --- |
| Experimental: Stereotactic radiotherapy<br>Arm A: Stereotactic radiotherapy to a dose of 66 Gy at the isocenter with 22 Gy per fraction in 3 fractions during one week with body frame fixation and a planning target volume with a 5 mm margin around the macroscopic tumour. A heterogeneous dose distribution is used so 45 Gy will cover the PTV. | Radiation: Stereotactic radiotherapy<br>* Margin between CTV and PTV of 5 mm in transversal direction (except for small targets (<3cm) not fixed to thoracic wall or mediastinal structures, where margin should be 10 mm) and 10 mm in longitudinal direction. Planned heterogeneous dose distribution within the PTV with about 50% higher dose to the center compared to the periphery. Hypofractionation with 22 Gy times 3 at the isocenter (15 Gy at the periphery of the PTV)during one week will be used.<br>|
| Active Comparator: Conventionally fractionated radiotherapy<br>Arm B: Conventionally fractionated radiotherapy to a dose of 70 Gy with 2 Gy per fraction in 35 fractions during 7 weeks with fixation in a vacuum pillow and a planning target volume with a 2 cm margin around the macroscopic tumour. | Radiation: Conventionally fractionated radiotherapy<br>* Clinical target volume (CTV) comprises the Gross Tumor Volume (GTV), including its diffuse growth at the borders. Planning target volume (PTV) is defined as the CTV with a total margin of 2 cm in all directions. The patient will receive 35 fractions, with a dose of 2.0 Gy/fraction at the ICRU reference point to a total dose of 70 Gy. The treatments will be given five days a week. The total treatment time should be as close to seven weeks as possible. The aim is that the dose distribution should be as homogeneous as possible.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from tumor progression | complete remission,partial remission or stable disease | At 36 months after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | At 36 monts after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-small call lung cancer, Medically inoperable, Stage one, Radiotherapy, SBRT, Hypofractionation, Conventional fractionation