Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005725

Trial Description

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Title

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

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Trial Acronym

LungTech

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Lung cancer is the leading cause of cancer death worldwide with a crude incidence of lung
cancer in the European Union of 52/100.000 per year and a mortality of 47/100.000 per year.
Non-small-cell lung cancer (NSCLC) accounts for approximately 80% of all cases. The five
year survival of NSCLC patients is quite poor (16%), mainly due to patients being diagnosed
at advanced stages. However if lung cancer can be detected and treated at an earlier stage
the outcome and survival is much more favorable with five year survival rates up to 77%.

The current standard of care for small volume tumors is surgical resection in medically fit
patients, consisting in lobectomy or pneumonectomy accompanied by a systematic mediastinal
lymph node sampling or lymphadenectomy. For the patient population with small volume disease
at early stage surgery offers the potential of local tumor control in up to 96% of the
patients.

However, about one quarter of the patients is medically inoperable because of coexisting
morbidities or poor general condition, mostly the result of a long smoking history and
consecutive chronic Obstructive pulmonary disease (COPD) and coronary artery disease (CAD).

The main purpose of this trial is to assess the effectiveness of IG-SBRT (Image guided
stereotactic body radiotherapy) in patients with medically inoperable early stage, centrally
located NSCLC and in those who are not willing to undergo surgical treatment.

Secondary objectives of the study are

- to assess safety of the treatment modality by collecting data about acute and late
toxicity

- patterns of local and distant recurrence and relation between the site of local
recurrence and the clinical (CTV) and planning target volume (PTV)

- survival and cause of death

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00005725
  •   2014/06/16
  •   2013/02/18
  •   yes
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Secondary IDs

  •   2012-000415-83 
  •   NCT01795521  (ClinicalTrials.gov)
  •   EORTC-22113-08113  (European Organisation for Research and Treatment of Cancer - EORTC)
  •   2012-000415-83 
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Health Condition or Problem studied

  •   C34 -  Malignant neoplasm of bronchus and lung
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Interventions/Observational Groups

  •   Radiation: Stereotactic Body Radiotherapy (SBRT)
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
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Primary Outcome

- Effectiveness of SBRT in early stage centrally located tumors, ≤ 7 cm; time frame: freedom from local progression rate at 3 years

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Secondary Outcome

toxicity,
pattern of recurrences,
overall survival,
cause of death

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Countries of Recruitment

  • [---]*
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Locations of Recruitment

  • University Medical Center 
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Recruitment

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  •   2013/12/31
  •   150
  •   Multicenter trial
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

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

- 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
trial

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

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Exclusion Criteria

- No prior RT of chest and/or mediastinum

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

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Addresses

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    • European Organisation for Research and Treatment of Cancer - EORTC
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    • University Hospital Freiburg
    • Nestlé Ursula 
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    • Hermans Julie 
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   6
  •   2014/02/05
* This entry means the parameter is not applicable or has not been set.