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Trial Title:
LungTech: Stereotactic Body Radiotherapy (SBRT) of Inoperable Centrally Located NSCLC
NCT ID:
NCT01795521
Condition:
Non-small Cell Lung Cancer Stage I
Non-small Cell Lung Cancer Stage II
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
NSCLC, SBRT, PET, Medically Inoperable
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Stereotactic Body Radiotherapy (SBRT)
Description:
A form of radiation therapy, where only the primary tumor is targeted and precise
stereotactic tumor localization combined with techniques reducing breathing- induced
target motion allowed small safety margins. These small volumes are treated with
hypo-fractionated, escalated irradiation doses. It's now further developed in multiple
clinical and technological aspects e.g. FDG-PET/CT based nodal staging, respiration
correlated CT- imaging for target volume definition and image-guided treatment delivery.
Arm group label:
Stereotactic Body Radiotherapy (SBRT)
Other name:
Stereotactic Ablative Body Radiotherapy (SABR)
Summary:
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
Detailed description:
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.
Criteria for eligibility:
Criteria:
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
Exclusion Criteria:
- No prior RT of chest and/or mediastinum
- No chemotherapy and/or targeted treatment within 3 months before the onset of RT
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cliniques Universitaires Saint-Luc
Address:
City:
Brussels
Zip:
1200
Country:
Belgium
Facility:
Name:
U.Z. Leuven - Campus Gasthuisberg
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Facility:
Name:
Universitaetsklinikum Freiburg
Address:
City:
Freiburg
Zip:
79106
Country:
Germany
Facility:
Name:
Universitaetsklinikum Wuerzburg
Address:
City:
Wuerzburg
Zip:
97080
Country:
Germany
Facility:
Name:
UniversitaetsSpital Zurich
Address:
City:
Zurich
Zip:
8091
Country:
Switzerland
Facility:
Name:
Royal Marsden Hospital - Sutton, Surrey
Address:
City:
Sutton
Zip:
SM2 5PT
Country:
United Kingdom
Start date:
August 2015
Completion date:
July 2021
Lead sponsor:
Agency:
European Organisation for Research and Treatment of Cancer - EORTC
Agency class:
Other
Source:
European Organisation for Research and Treatment of Cancer - EORTC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01795521