Clinical trial NCT04684186: Comparison Between Endovascular and Bronchoscopic Tumor Marker Insertion for Real-time Stereotactic-guided Radiotherapy in Lung Cancer
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Lung Metastases
Radiotherapy
Keywords: fiducial marker placement
stereotactic body radiotherapy
interventional radiology
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with lung cancer (1ary and 2ndary), not eligible for surgery, and treated by radiation therapy needing a fiducial marker placement will be eligible for this study which is a prospective randomized controlled trial (endovascular vs endobronchic fiducial marker).

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Cyberknife© tracking
timeFrame: Before Cyberknife
Secondary outcomes:
measure: Fiducial implantation evaluation by operator
timeFrame: Immediately post-implantation
measure: Fiducial marker migration
timeFrame: Immediately post-implantation and before Cyberknife
measure: Procedure time
timeFrame: Immediately after the procedure
measure: Complication rate
timeFrame: within 30 days of fiducial marker placement
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire vaudois - Department of Radiology and Interventional Radiology
state: VD
Study officials:
References:
citation: Hagmeyer L, Priegnitz C, Kocher M, Schilcher B, Budach W, Treml M, Stieglitz S, Randerath W. Fiducial marker placement via conventional or electromagnetic navigation bronchoscopy (ENB): an interdisciplinary approach to the curative management of lung cancer. Clin Respir J. 2016 May;10(3):291-7. doi: 10.1111/crj.12214. Epub 2014 Nov 3.
citation: Harada T, Shirato H, Ogura S, Oizumi S, Yamazaki K, Shimizu S, Onimaru R, Miyasaka K, Nishimura M, Dosaka-Akita H. Real-time tumor-tracking radiation therapy for lung carcinoma by the aid of insertion of a gold marker using bronchofiberscopy. Cancer. 2002 Oct 15;95(8):1720-7. doi: 10.1002/cncr.10856.
citation: Siegel R, Ward E, Brawley O, Jemal A. Cancer statistics, 2011: the impact of eliminating socioeconomic and racial disparities on premature cancer deaths. CA Cancer J Clin. 2011 Jul-Aug;61(4):212-36. doi: 10.3322/caac.20121. Epub 2011 Jun 17.
citation: Ferlay J, Steliarova-Foucher E, Lortet-Tieulent J, Rosso S, Coebergh JW, Comber H, Forman D, Bray F. Cancer incidence and mortality patterns in Europe: estimates for 40 countries in 2012. Eur J Cancer. 2013 Apr;49(6):1374-403. doi: 10.1016/j.ejca.2012.12.027. Epub 2013 Feb 26.
citation: Detterbeck FC, Lewis SZ, Diekemper R, Addrizzo-Harris D, Alberts WM. Executive Summary: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):7S-37S. doi: 10.1378/chest.12-2377. No abstract available.
citation: Detterbeck FC. Lobectomy versus limited resection in T1N0 lung cancer. Ann Thorac Surg. 2013 Aug;96(2):742-4. doi: 10.1016/j.athoracsur.2013.03.074. No abstract available.
citation: Stefani A, Nesci J, Casali C, Morandi U. Wedge resection versus lobectomy for T1N0 non-small cell lung cancer. Minerva Chir. 2012 Dec;67(6):489-98.
citation: Ahn SH, Han MS, Yoon JH, Jeon SY, Kim CH, Yoo HJ, Lee JC. Treatment of stage I non-small cell lung cancer with CyberKnife, image-guided robotic stereotactic radiosurgery. Oncol Rep. 2009 Mar;21(3):693-6.
citation: Shen ZT, Wu XH, Li B, Zhu XX. Clinical outcomes of CyberKnife stereotactic body radiotherapy for peripheral stage I non-small cell lung cancer. Med Oncol. 2015 Mar;32(3):55. doi: 10.1007/s12032-015-0506-1. Epub 2015 Feb 1.
citation: van der Voort van Zyp NC, Hoogeman MS, van de Water S, Levendag PC, van der Holt B, Heijmen BJ, Nuyttens JJ. Stability of markers used for real-time tumor tracking after percutaneous intrapulmonary placement. Int J Radiat Oncol Biol Phys. 2011 Nov 1;81(3):e75-81. doi: 10.1016/j.ijrobp.2010.12.026. Epub 2011 Feb 23.
citation: Patel A, Khalsa B, Lord B, Sandrasegaran K, Lall C. Planting the seeds of success: CT-guided gold seed fiducial marker placement to guide robotic radiosurgery. J Med Imaging Radiat Oncol. 2013 Apr;57(2):207-11. doi: 10.1111/j.1754-9485.2012.02445.x. Epub 2012 Sep 21.
citation: Habermehl D, Henkner K, Ecker S, Jakel O, Debus J, Combs SE. Evaluation of different fiducial markers for image-guided radiotherapy and particle therapy. J Radiat Res. 2013 Jul;54 Suppl 1(Suppl 1):i61-8. doi: 10.1093/jrr/rrt071.
citation: Chan MF, Cohen GN, Deasy JO. Qualitative evaluation of fiducial markers for radiotherapy imaging. Technol Cancer Res Treat. 2015 Jun;14(3):298-304. doi: 10.1177/1533034614547447. Epub 2014 Sep 16.
citation: Pepin E, Olsen L, Badiyan S, Murad F, Mullady D, Wang-Gillam A, Linehan D, Parikh P, Olsen J. Comparison of implanted fiducial markers and self-expandable metallic stents for pancreatic image guided radiation therapy localization. Pract Radiat Oncol. 2015 May-Jun;5(3):e193-e199. doi: 10.1016/j.prro.2014.08.019. Epub 2014 Oct 3.
citation: 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. No abstract available.
citation: Nuyttens JJ, Prevost 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. doi: 10.1080/02841860600902205.
citation: Shirato H, Harada T, Harabayashi T, Hida K, Endo H, Kitamura K, Onimaru R, Yamazaki K, Kurauchi N, Shimizu T, Shinohara N, Matsushita M, Dosaka-Akita H, Miyasaka K. Feasibility of insertion/implantation of 2.0-mm-diameter gold internal fiducial markers for precise setup and real-time tumor tracking in radiotherapy. Int J Radiat Oncol Biol Phys. 2003 May 1;56(1):240-7. doi: 10.1016/s0360-3016(03)00076-2.
citation: Chen AP, Setser A, Anadkat MJ, Cotliar J, Olsen EA, Garden BC, Lacouture ME. Grading dermatologic adverse events of cancer treatments: the Common Terminology Criteria for Adverse Events Version 4.0. J Am Acad Dermatol. 2012 Nov;67(5):1025-39. doi: 10.1016/j.jaad.2012.02.010. Epub 2012 Apr 11.
citation: Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
citation: Prevost JB, Nuyttens JJ, Hoogeman MS, Poll 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.
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.
citation: 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 pulmonary tumors. Int J Radiat Oncol Biol Phys. 2011 Sep 1;81(1):85-90. doi: 10.1016/j.ijrobp.2010.04.037. Epub 2010 Aug 1.