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LungTech Stereotactic Body Radiotherapy (SBRT) of Inoperable Centrally Located NSCLC: A Phase II Study in Preparation for a Randomized Phase III Trial

Phase 2
18 Years
Not Enrolling
Non-small Cell Lung Cancer Stage I, Non-small Cell Lung Cancer Stage II

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Trial Information

LungTech Stereotactic Body Radiotherapy (SBRT) of Inoperable Centrally Located NSCLC: A Phase II Study in Preparation for a Randomized Phase III Trial

Conventionally fractionated radiotherapy (RT) has been the standard of care for medically
inoperable NSCLC with prescribed doses of usually 60 - 66 Gy.This moderate irradiation
regimen resulted in a local failure rate of approximately 50% and local failure- not distant
- has been shown to be the most frequent pattern of disease recurrence. Still, conventional
RT resulted in overall survival (OS) and cancer specific survival (CSS) superior to best
supportive care, though it is clearly an insufficient treatment with CSS rates of only about
30% after 5 years.

Retrospective studies reported a dose-response relationship for local tumor control: higher
irradiation doses resulted in improved rates of local tumor control which was found to
translate into improved OS. Simultaneously, a dose- response relationship with a
volume-effect relation has been demonstrated for radiation induced pneumonitis, being the
most relevant toxicity after RT. These relations are known to apply to other organs at risk
(OAR)including esophagus and spinal cord. Consequently, traditional target volume concepts
conducting nodal irradiation in clinically node negative patients and traditional RT-
planning and delivery techniques, with low accuracy and broad safety margins, do not allow
the routine application of sufficient irradiation doses due to high toxicity rates.

In the mid-90s, after encouraging success in the treatment of cerebral malignancies, the
concept of stereotactic RT was taken over from the cranium to the body. Only the primary
tumor was targeted and precise stereotactic tumor localization combined with techniques
reducing breathing- induced target motion allowed small safety margins. These small volumes
were treated with hypo-fractionated, escalated irradiation doses. Since then, the technique
of image guided (IG) -stereotactic body RT (SBRT) also known as Stereotactic Ablative Body
Radiotherapy (SABR) was further developed in multiple clinical and technological aspects
e.g. Fluorine-18 Fluorodeoxyglucose positron emission tomography / computed tomography
(FDG-PET/CT) based nodal staging, respiration correlated CT-imaging for target volume
definition and image-guided treatment delivery.

Safety and efficacy has been demonstrated in a large series of patients with stage I NSCLC.
The majority of patients were medically inoperable and SBRT was practiced instead of
conventionally fractionated RT. However, safety of SBRT has been demonstrated even in high
risk patients with advanced age, severe COPD and very poor pulmonary function, which would
have made any curative approach except SBRT difficult or even impossible. On the other side
of the patient spectrum, retrospective studies suggested equivalent outcome compared to
sub-lobar resection, which is confirmed by Markov modelling studies.

Inclusion Criteria:

- Diagnosis of non-small cell lung cancer (NSCLC), either confirmed by histology or

- Patient deemed medically inoperable after assessment in a multimodality tumor board
or refusing surgery

- Tumor size < 5 cm, or 5-7 cm (strict separate stopping rules will be applied for the
latter population)

- Central tumor location i.e. tumor in or abutting a zone within 2 cm of the proximal
bronchial tree or other parts of the mediastinum, eligibility of each case underlying
expert review

- Staging- whole body FDG-PET/CT acquired within 4 weeks prior to inclusion. In case of
uncertainty about affection of hilar/mediastinal nodes, endobronchial
ultrasound-transbronchial needle aspiration(EBUS-TBNA) is strongly recommended

- N0 tumors

- T3 tumors only if: not within the mediastinum and not abutting the oesophagus and
only one lesion

- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

- Age ≥ 18 years

- Patients of childbearing / reproductive potential should use adequate birth control
measures, as defined by the investigator, during the study treatment period. A highly
effective method of birth control is defined as those which result in low failure
rate (i.e. less than 1% per year) when used consistently and correctly.

- Absence of any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule;
those conditions should be discussed with the patient before registration in the

- Before patient registration, written informed consent must be given according to
International Conference on Harmonization /Good Clinical Practice (ICH/GCP), and
national/local regulations

Exclusion Criteria:

- No prior RT of chest and/or mediastinum

- No chemotherapy and/or targeted treatment within 3 months before the onset of RT

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Effectiveness of SBRT in early stage centrally located tumors, ≤ 7 cm

Outcome Time Frame:

freedom from local progression rate at 3 years

Safety Issue:


Principal Investigator

Nestlé Ursula

Investigator Role:

Study Chair

Investigator Affiliation:

University Hospital Freiburg


Belgium: Ethics Committee

Study ID:




Start Date:

December 2013

Completion Date:

December 2019

Related Keywords:

  • Non-small Cell Lung Cancer Stage I
  • Non-small Cell Lung Cancer Stage II
  • NSCLC, SBRT, PET, Medically Inoperable
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms