Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatments stereotactic radiotherapy, conventionally fractionated radiotherapy
Sponsor Ass. Prof. Jan Nyman
Collaborator Göteborg University
Start date January 2007
End date March 2015
Trial size 102 participants
Trial identifier NCT01920789, SPACE

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
(Active Comparator)
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.

Primary Outcomes

Measure
Freedom from tumor progression
time frame: At 36 months after randomization

Secondary Outcomes

Measure
Overall survival
time frame: At 36 monts after randomization

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

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
Principal investigator Jan Nyman, Ass. Prof
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Swedish Lung Cancer Study Group.