Clinical trial NCT01920789: Stereotactic Precision And Conventional Radiotherapy Evaluation
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-small Cell Lung Cancer
Keywords: Non-small call lung cancer
Medically inoperable
Stage one
Radiotherapy
SBRT
Hypofractionation
Conventional fractionation
Lead sponsor: Swedish Lung Cancer Study Group
Sponsor class: NETWORK
Collaborators: name: Göteborg University
name: Karolinska Institutet
First posted: 2013-08-12
Enrollment: 102
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Freedom from tumor progression
timeFrame: At 36 months after randomization
Secondary outcomes:
measure: Overall survival
timeFrame: At 36 monts after randomization
Other outcomes:
measure: Toxicity
timeFrame: At 7 weeks, 3, 6, 12, 18, 24 and 36 months after randomization
measure: Quality of life
timeFrame: At 7 weeks, 6 and 24 months after randomization
Locations:
Study officials:
affiliation: Department of Oncology, Sahlgrenska University Hospital
name: Jan Nyman, Ass. Prof
role: PRINCIPAL_INVESTIGATOR
References: