Ignite Creation Date:
2024-05-06 @ 1:23 AM
Last Modification Date:
2024-10-26 @ 11:03 AM
Study NCT ID:
NCT01795521
Status:
UNKNOWN
Last Update Posted:
2020-01-31
First Post:
2013-02-18
Brief Title:
LungTech Stereotactic Body Radiotherapy SBRT of Inoperable Centrally Located NSCLC
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
LungTech Stereotactic Body Radiotherapy SBRT of Inoperable Centrally Located NSCLC A Phase II Study in Preparation for a Randomized Phase III Trial
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LungTech
Brief Summary:
Lung cancer is the leading cause of cancer death worldwide with a crude incidence of lung cancer in the European Union of 52100000 per year and a mortality of 47100000 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
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 GyThis 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 OARincluding 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 eg Fluorine-18 Fluorodeoxyglucose positron emission tomography computed tomography FDG-PETCT 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
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 OARincluding 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 eg Fluorine-18 Fluorodeoxyglucose positron emission tomography computed tomography FDG-PETCT 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2012-000415-83 | EUDRACT_NUMBER | None | None |