An interventional study of Stereotactic radiotherapy and Conventionally fractionated radiotherapy in Non-small Cell Lung Cancer, sponsored by Ass. Prof. Jan Nyman. Status unknown. Per ClinicalTrials.gov, last updated 2014-12-09.
Sponsored by Ass. Prof. Jan Nyman · Not applicable, Interventional, and Treatment
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.
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 102 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Ass. Prof. Jan Nyman is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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
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
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.
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.
Freedom from tumor progression
complete remission,partial remission or stable disease
Time frame: At 36 months after randomization
Overall survival
Time frame: At 36 monts after randomization
Toxicity
CTC version 3.0 will be used for acute and late toxicity
Time frame: At 7 weeks, 3, 6, 12, 18, 24 and 36 months after randomization
Quality of life
EORTC QLQ 30 + LC 14 questionnaire will be used
Time frame: At 7 weeks, 6 and 24 months after randomization
No study locations are listed for this record.
This study is status unknown, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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