SPACE: Stereotactic Precision And Conventional Radiotherapy Evaluation

Sponsor

Ass. Prof. Jan Nyman (Other)

Overall Status

Unknown status

CT.gov ID

NCT01920789

Collaborator

Göteborg University (Other), Karolinska Institutet (Other)

102

Enrollment

Arms

97.9

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer	Radiation: Stereotactic radiotherapy Radiation: Conventionally fractionated radiotherapy	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

102 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 :

Jan 1, 2007

Anticipated Primary Completion Date :

Mar 1, 2015

Anticipated Study Completion Date :

Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Freedom from tumor progression [At 36 months after randomization]
complete remission,partial remission or stable disease

Secondary Outcome Measures

Overall survival [At 36 monts after randomization]

Other Outcome Measures

Toxicity [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 [At 7 weeks, 6 and 24 months after randomization]
EORTC QLQ 30 + LC 14 questionnaire will be used

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.