Lung Cancer Clinical Trial
Official title:
Real-time Guided Stereotactic Radiotherapy in Lung Cancer Using Endovascular Coils for Tumor Marking: Head-to-head Comparison Between Endovascular and Bronchoscopic Fiducial Marker Insertion
NCT number | NCT04684186 |
Other study ID # | 2016-00046 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 10, 2016 |
Est. completion date | June 1, 2026 |
The role of radiotherapy is well established in the management of early stage lung cancer or as part of a multidisciplinary approach of locally advanced lung cancer (1). Recent advances in Cyberknife© technology, which is a robotic system of stereotactic irradiation including localisation and real time lesion-tracking, has led to an increase in accuracy and potentially in efficiency of the irradiation of tumor field (2)(3). According to several studies, promising results in local control and survival rates have been achieved in patients suffering from primary lung cancer or peripheral lung metastasis treated with Cyberknife© (4)(5)(6)(7)(8). Fiducial markers are implanted in or near a tumor in a configuration defining a COM (center of mass) guiding the Cyberknife for tumor localization. Tumor movement is then synchronized to respiratory cycle motion during treatment which reduces toxicity of non target lung tissue irradiation. Change in marker positioning leads to COM alterations, thus limiting detection by the tracking system. Percutaneous (9)(10)(11) (12), endovascular (12)(13) fiducial implantation or by means of bronchoscopic devices (14)(15)(16)(17)(18) are three techniques that have been validated in previous studies as feasible and safe procedures, providing accurate tracking. Few studies are currently available in the litterature comparing these modalities (19)(20). The percutaneous implantation technique will not be considered for this study because this technique is associated with a high risk of pneumothorax (9). Both the endobronchial and endovascular technique have been described in the literature with equivalent success rate (87-90%) in intention to treat (21)(22). One of the endpoints of this study is to verify that these results are reproducible in our institution where both techniques are currently available and to investigate other secondary endpoints such as fiducial marker migration after placement, complications rates and procedure time.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | June 1, 2026 |
Est. primary completion date | June 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Lung cancer (primary or secondary, any histological type) - Early stage lung cancer: patients diagnosed with stage I for which operation is contra-indicated, for example because of cardiac or pulmonary comorbidities. - Locally advanced lung cancer stages II - IIIB - Metastatic lung cancer stage IV (palliative care) - 18 y = age = 85 y Exclusion Criteria: - age <18y - incapacity of judgment - Absence of a signed consent form |
Country | Name | City | State |
---|---|---|---|
Switzerland | Centre Hospitalier Universitaire vaudois - Department of Radiology and Interventional Radiology | Lausanne | VD |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire Vaudois |
Switzerland,
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Boschini FJ, Commander CW, Schreiber EC, Yu H, Dixon RG. Comparison of Gold Seeds, Tight Embolization Coils, and Loose Embolization Coils Used as Fiducial Markers for Dynamic Tracking Using CyberKnife. Pract Radiat Oncol. 2013 Apr-Jun;3(2 Suppl 1):S22. doi: 10.1016/j.prro.2013.01.074. Epub 2013 Mar 25. — View Citation
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Hong JC, Yu Y, Rao AK, Dieterich S, Maxim PG, Le QT, Diehn M, Sze DY, Kothary N, Loo BW Jr. High retention and safety of percutaneously implanted endovascular embolization coils as fiducial markers for image-guided stereotactic ablative radiotherapy of pu — View Citation
Nuyttens JJ, Prévost JB, Praag J, Hoogeman M, Van Klaveren RJ, Levendag PC, Pattynama PM. Lung tumor tracking during stereotactic radiotherapy treatment with the CyberKnife: Marker placement and early results. Acta Oncol. 2006;45(7):961-5. — View Citation
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Prévost JB, Nuyttens JJ, Hoogeman MS, Pöll JJ, van Dijk LC, Pattynama PM. Endovascular coils as lung tumour markers in real-time tumour tracking stereotactic radiotherapy: preliminary results. Eur Radiol. 2008 Aug;18(8):1569-76. doi: 10.1007/s00330-008-0933-x. Epub 2008 Apr 4. — View Citation
Schroeder C, Hejal R, Linden PA. Coil spring fiducial markers placed safely using navigation bronchoscopy in inoperable patients allows accurate delivery of CyberKnife stereotactic radiosurgery. J Thorac Cardiovasc Surg. 2010 Nov;140(5):1137-42. doi: 10.1016/j.jtcvs.2010.07.085. Epub 2010 Sep 20. — View Citation
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* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cyberknife© tracking | Tumor tracking assessment by Cyberknife© after bronchoscopic and endovascular fiducial marker implantation | Before Cyberknife | |
Secondary | Fiducial implantation evaluation by operator | Assessment of technical feasibility of implantation of at least three fiducial markers around the lung tumor in both techniques | Immediately post-implantation | |
Secondary | Fiducial marker migration | Secondary fiducial migration rate assessment in both techniques | Immediately post-implantation and before Cyberknife | |
Secondary | Procedure time | Procedure time required for the implantation of three markers around the lung tumor in both techniques | Immediately after the procedure | |
Secondary | Complication rate | Complication rate (AE/SEA) within 30 days of fiducial marker placement in both techniques | within 30 days of fiducial marker placement |
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