Stereotactic Precision And Conventional Radiotherapy Evaluation (SPACE)
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|ClinicalTrials.gov Identifier: NCT01920789|
Recruitment Status : Unknown
Verified December 2014 by Ass. Prof. Jan Nyman, Swedish Lung Cancer Study Group.
Recruitment status was: Active, not recruiting
First Posted : August 12, 2013
Last Update Posted : December 9, 2014
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Radiation: Stereotactic radiotherapy Radiation: Conventionally fractionated radiotherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||102 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2007|
|Estimated Primary Completion Date :||March 2015|
|Estimated Study Completion Date :||March 2015|
Experimental: 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.
Radiation: 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.
Active Comparator: 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.
Radiation: 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.
- Freedom from tumor progression [ Time Frame: At 36 months after randomization ]complete remission,partial remission or stable disease
- Overall survival [ Time Frame: At 36 monts after randomization ]
- Toxicity [ Time Frame: At 7 weeks, 3, 6, 12, 18, 24 and 36 months after randomization ]CTC version 3.0 will be used for acute and late toxicity
- Quality of life [ Time Frame: At 7 weeks, 6 and 24 months after randomization ]EORTC QLQ 30 + LC 14 questionnaire will be used
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920789
|Principal Investigator:||Jan Nyman, Ass. Prof||Department of Oncology, Sahlgrenska University Hospital|