Stereotactic Precision And Conventional Radiotherapy Evaluation

Not Applicable

• Conditions: Non-small Cell Lung Cancer
• Interventions: Radiation: Stereotactic radiotherapy; Radiation: Conventionally fractionated radiotherapy

• Registration Number: NCT01920789
• Lead Sponsor: Ass. Prof. Jan Nyman

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.

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 Timeline

• Study Start: 2007-01
• Study First Submitted: 2013-08-05
• Study First Submitted QC: 2013-08-08
• Study First Posted: 2013-08-12
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-08
• Last Update Posted: 2014-12-09
• Primary Completion: 2015-03
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Not specified
• Target Recruitment: 102

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stereotactic radiotherapy	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.
Conventionally fractionated radiotherapy	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.

Primary Outcome Measures

Name	Time	Method
Freedom from tumor progression	At 36 months after randomization	complete remission,partial remission or stable disease

Secondary Outcome Measures

Name	Time	Method
Overall survival	At 36 monts after randomization