Clinical trial · Interventional
Stereotactic Precision And Conventional Radiotherapy Evaluation
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
NCT01920789CI-TRIAL-00016294SPACEunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventionally fractionated radiotherapy | Radiation | — | UNRESOLVED |
| Stereotactic radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Stereotactic radiotherapy
- description
- 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.
- interventionNames
- Radiation: Stereotactic radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Conventionally fractionated radiotherapy
- description
- 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.
- interventionNames
- Radiation: Conventionally fractionated radiotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.