The primary objective of this trial is to assess the effectiveness of IG-SBRT in patients with medically inoperable early stage, centrally located NSCLC and in those who are not willing to undergo surgical treatment.The primary measure of…
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- freedom from local progression at three years
Secondary outcome
- acute and late toxicity
- patterns of local and distant recurrence
- overall survival and cause of death
Background summary
It has been demonstrated in peripherally located tumors that SBRT is more
effective than conventional RT due to delivery of higher BED. Modern imaging
techniques combined with high-precision dose delivery enable a significant
reduction in target volume size and exposure of normal tissue to high doses
resulting in decreased toxicity risk. Furthermore, the time course for these
treatment schedules is considerably shorter than conventional RT (typically
30-33 fractions) which is more convenient for both patients and RT departments
leading to an increased biological effectiveness.
Single center experience with SBRT has been reported but the effectiveness and
safety of this technique has not been reported in the context of a multi-center
setting for centrally located tumors. The primary aim of this study is to
evaluate the freedom from local progression and toxicity of SBRT for patients
with early stage, centrally located, inoperable NSCLC.
Study objective
The primary objective of this trial is to assess the effectiveness of IG-SBRT
in patients with medically inoperable early stage, centrally located NSCLC and
in those who are not willing to undergo surgical treatment.
The primary measure of effectiveness will be freedom from local progression at
three years as assessed by serial CT scans. Equivocal findings or progressive
soft tissue abnormalities will be evaluated by FDG-PET/CT. If still unclear,
biopsies (if clinically indicated and the patient*s condition is allowing for
it) or repeat imaging (within 3 months of the previous imaging) shall be
performed, providing that the patient is fit enough to undergo such a procedure.
Translational research (optional):
- Staging comparison between 3D and 4D FDG-PET/CT assesment
- Possible impact of 4D FDG-PET/CT on target volume contouring
- External validation of Huang Criteria
- Value of post treatment imaging for assessment of local control and toxicity
after SBRT
Study design
This is a non-randomized, single arm multicenter phase II trial. The objective
of the trial is to assess the effectiveness of SBRT in early stage centrally
located tumors, * 7 cm.
Intervention
Image guided SBRT with CBCT verification 7.5 Gy *8 fractions = 60 Gy
Translational research (optional): 2 x 4D FDG-PET/CT
Study burden and risks
Until now, the available single center data from Amsterdam suggest an expected
rate of grade III toxicity of < 10%. However, the main safety concern is
radiation induced normal tissue toxicity, which is a secondary endpoint and
which will be watched closely during the whole study period.
All adverse events will be recorded; the investigator will assess whether those
events are treatment related (reasonable possibility, no reasonable
possibility) and this assessment will be recorded in the database for all
adverse events.
The restriction of RT dose application to the macroscopic tumor and the
possibility to use only very small margins due to high precision techniques
leads to avoidance of the irradiation of large volumes of unaffected normal
tissues. Therefore, it may be possible to reduce clinically significant
radiation induced toxicity in parallel organs (e.g. lung). The focus of
toxicity largely lies inserial organs within or in the immediate neighborhood
of the PTV like central bronchi, heart, oesophagus and large vessels. Toxicity
in these organs may include strictures, fistulae or bleeding.
Avenue Emmanuel Mounier 83/11
Brussel 1200
BE
Avenue Emmanuel Mounier 83/11
Brussel 1200
BE
Listed location countries
Age
Inclusion criteria
- Diagnosis of non-metastatic NSCLC, confirmed by either histology or cytology.
- Centrally located tumor defined as tumor within 2 cm or touching the zone of the proximal bronchial tree or tumor that is immediately adjacent to the mediastinal or pericardial pleura, with a PTV expected to touch or include the pleura.
- Patient deemed medically inoperable after assessment in a multimodality tumor board or refusing surgery.
- Tumor size * 7 cm (T1-T3 N0 according to UICC 7th Edition 2011).
- T3 tumors will be accepted only if one lesion and not abutting the oesophagus.
- Whole body FDG-PET scan acquired before inclusion, combined with either
whole body CT or CT of chest and upper abdomen. In case of uncertainty about involvement of hilar/mediastinal nodes, endobronchial ultrasound-transbronchial needle aspiration (EBUS-TBNA) is strongly recommended
- Expert central review of all staging FDG-PET/CT images before inclusion by an experienced radiation oncologist and a PET/CT specialist.
- Treatment must be planned to start within 6 weeks of FDG-PET/CT.
- No prior radiotherapy to chest and/or mediastinum
- No chemotherapy and/or targeted treatment within 3 months before the start of SBRT
- WHO performance status * 2
- Age * 18 years
- Patients of childbearing / reproductive potential should use adequate birth control measures, 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.
- No other malignancy except adequately treated basal cell carcinoma of the skin or other malignancy from which the patient has been disease free for at least 5 years.
- 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 ICH/GCP, and national/local regulations
Exclusion criteria
- Women must not be pregnant
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01795521 |
| CCMO | NL48863.031.14 |