Stereotactic Precision And Conventional Radiotherapy Evaluation (SPACE)
|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
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|