Stereotactic Precision And Conventional Radiotherapy Evaluation
NCT ID: NCT01920789
Last Updated: 2014-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
102 participants
INTERVENTIONAL
2007-01-31
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Stereotactic radiotherapy
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.
Stereotactic radiotherapy
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.
Conventionally fractionated radiotherapy
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.
Conventionally fractionated radiotherapy
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.
Interventions
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Stereotactic radiotherapy
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.
Conventionally fractionated radiotherapy
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
No
Sponsors
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Göteborg University
OTHER
Karolinska Institutet
OTHER
Ass. Prof. Jan Nyman
NETWORK
Responsible Party
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Ass. Prof. Jan Nyman
Ass. Prof. Jan Nyman
Principal Investigators
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Jan Nyman, Ass. Prof
Role: PRINCIPAL_INVESTIGATOR
Department of Oncology, Sahlgrenska University Hospital
Other Identifiers
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SPACE
Identifier Type: -
Identifier Source: org_study_id