Non-small Cell Lung Cancer Stage IPhase 2LungTechNCT01795521
LungTech: Stereotactic Body Radiotherapy (SBRT) of Inoperable Centrally Located NSCLC
A Phase 2 study testing Stereotactic Body Radiotherapy (SBRT) in people with Non-small Cell Lung Cancer Stage I and Non-small Cell Lung Cancer Stage II, run by European Organisation for Research and Treatment of Cancer - EORTC at 6 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer Stage I, Non-small Cell Lung Cancer Stage II
- What is being tested?
- Stereotactic Body Radiotherapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 6 sitesin 4 countries
- Study dates
- Aug 2015to Jul 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- No prior RT of chest and/or mediastinum
- No chemotherapy and/or targeted treatment within 3 months before the onset of RT
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Belgium2 sites
Cliniques Universitaires Saint-Luc
Brussels, 1200
U.Z. Leuven - Campus Gasthuisberg
Leuven, 3000
Germany2 sites
Universitaetsklinikum Freiburg
Freiburg im Breisgau, 79106
Universitaetsklinikum Wuerzburg
Würzburg, 97080
United Kingdom1 site
Royal Marsden Hospital - Sutton, Surrey
Sutton, Surrey, SM2 5PT
About this study
Official title: LungTech Stereotactic Body Radiotherapy (SBRT) of Inoperable Centrally Located NSCLC: A Phase II Study in Preparation for a Randomized Phase III Trial
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.
Read more
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
Read the 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.
- Being tested
- Stereotactic Body Radiotherapy (SBRT)
- Keywords
- NSCLC, SBRT, PET, Medically Inoperable
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiotherapy (SBRT)Radiation
Also called Stereotactic Ablative Body Radiotherapy (SABR)
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.
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Body Radiotherapy (SBRT) | Experimental | All eligible patients will be offered Stereotactic Body Radiotherapy using Four-dimensional computed tomography (4D-CT) planning (as a minimum), delivering a dose of 60 Gy in 8 fractions of 7.5 Gy on alternate days over a planned treatment time of 2.5 weeks Receives: Radiation: Stereotactic Body Radiotherapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of SBRT in early stage centrally located tumors, ≤ 7 cm
Measured: freedom from local progression rate at 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study startAug 2015
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung Cancer Stage IStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Nestlé Ursula, Study chair, University Hospital Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01795521
- Sponsor's protocol ID
- EORTC-22113-08113
- Other IDs
- 2012-000415-83
- Acronym
- LungTech
- Status last verified
- Jan 2020
- First submitted
- 18 Feb 2013
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Levy A, Guckenberger M, Hurkmans C, Nestle U, Belderbos J, De Ruysscher D, Faivre-Finn C, Le Pechoux C. SBRT Dose and Survival in Non-Small Cell Lung Cancer: In Regard to Koshy et al. Int J Radiat Oncol Biol Phys. 2015 Jul 15;92(4):945-6. doi: 10.1016/j.ijrobp.2015.03.032. No abstract available.
PubMed 26104945
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LungTech Stereotactic Body Radiotherapy (SBRT) of Inoperable Centrally Located NSCLC: A Phase II Study in Preparation for a Randomized Phase III Trial
- ClinicalTrials.gov ID
- NCT01795521
- Acronym / sponsor ID
- LungTech / EORTC-22113-08113
- Keywords
- NSCLC, SBRT, PET, Medically Inoperable
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Aug 2015
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 20 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Body Radiotherapy (SBRT) | Experimental | Radiation: Stereotactic Body Radiotherapy (SBRT)All eligible patients will be offered Stereotactic Body Radiotherapy using Four-dimensional computed tomography (4D-CT) planning (as a minimum), delivering a dose of 60 Gy in 8 fractions of 7.5 Gy on alternate days over a planned treatment time of 2.5 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (2 listed)
- No prior RT of chest and/or mediastinum
- No chemotherapy and/or targeted treatment within 3 months before the onset of RT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Body Radiotherapy (SBRT)Also: Stereotactic Ablative Body Radiotherapy (SABR)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. | Radiation | Stereotactic Body Radiotherapy (SBRT) |
Primary outcome
Effectiveness of SBRT in early stage centrally located tumors, ≤ 7 cm
Time frame: freedom from local progression rate at 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Derived from this study: PubMed 26104945Levy A, Guckenberger M, Hurkmans C, Nestle U, Belderbos J, De Ruysscher D, Faivre-Finn C, Le Pechoux C. SBRT Dose and Survival in Non-Small Cell Lung Cancer: In Regard to Koshy et al. Int J Radiat Oncol Biol Phys. 2015 Jul 15;92(4):945-6. doi: 10.1016/j.ijrobp.2015.03.032. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nestlé Ursula study chair
University Hospital Freiburg
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stereotactic Body Radiotherapy (SBRT) in people with Non-small Cell Lung Cancer Stage I and Non-small Cell Lung Cancer Stage II, run by European Organisation for Research and Treatment of Cancer - EORTC at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium, Germany, Switzerland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of SBRT in early stage centrally located tumors, ≤ 7 cm (time frame: freedom from local progression rate at 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01795521, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2020.