Stereotactic Precision And Conventional Radiotherapy Evaluation
This trial is active, not recruiting.
|Condition||non-small cell lung cancer|
|Treatments||stereotactic radiotherapy, conventionally fractionated radiotherapy|
|Sponsor||Ass. Prof. Jan Nyman|
|Start date||January 2007|
|End date||March 2015|
|Trial size||102 participants|
|Trial identifier||NCT01920789, SPACE|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Freedom from tumor progression
time frame: At 36 months after randomization
time frame: At 36 monts after randomization
Male or female participants of any age.
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.
|Official title||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|
|Principal investigator||Jan Nyman, Ass. Prof|
|Description||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.|
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