Status:
UNKNOWN
Stereotactic Precision And Conventional Radiotherapy Evaluation
Lead Sponsor:
Ass. Prof. Jan Nyman
Collaborating Sponsors:
Göteborg University
Karolinska Institutet
Conditions:
Non-small Cell Lung Cancer
Phase:
NA
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 ra...
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 inopera...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT01920789
Start Date
January 1 2007
End Date
March 1 2015
Last Update
December 9 2014
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