Randomized Trial on Intraoperative Radiotherapy Full Dose Vs External Radiotherapy (ELIOT)

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ClinicalTrials.gov Identifier: NCT01849133

Recruitment Status : Completed

First Posted : May 8, 2013

Last Update Posted : May 8, 2013

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Sponsor:

Information provided by (Responsible Party):

European Institute of Oncology

No Study Results Posted on ClinicalTrials.gov for this Study

About Study Results Reporting on ClinicalTrials.gov

Recruitment Status :	Completed
Actual Primary Completion Date :	December 2012
Actual Study Completion Date :	December 2012

Publications of Results:

Intra M, Luini A, Gatti G, Ciocca M, Gentilini OD, Viana AA, Chagas EM, Berrettini A, Schuh F, Scarpa D, Orecchia R, Veronesi U. Surgical technique of intraoperative radiation therapy with electrons (ELIOT) in breast cancer: a lesson learned by over 1000 procedures. Surgery. 2006 Sep;140(3):467-71. doi: 10.1016/j.surg.2006.03.019. No abstract available.

Other Publications:

Veronesi U, Orecchia R, Luini A, Gatti G, Intra M, Zurrida S, Ivaldi G, Tosi G, Ciocca M, Tosoni A, De Lucia F. A preliminary report of intraoperative radiotherapy (IORT) in limited-stage breast cancers that are conservatively treated. Eur J Cancer. 2001 Nov;37(17):2178-83. doi: 10.1016/s0959-8049(01)00285-4.

Gatzemeier W, Orecchia R, Gatti G, Intra M, Veronesi U. [Intraoperative radiotherapy (IORT) in treatment of breast carcinoma--a new therapeutic alternative within the scope of breast-saving therapy? Current status and future prospects. Report of experiences from the European Institute of Oncology (EIO), Mailand]. Strahlenther Onkol. 2001 Jul;177(7):330-7. doi: 10.1007/pl00002415. German.

Intra M, Gatti G, Luini A, Galimberti V, Veronesi P, Zurrida S, Frasson A, Ciocca M, Orecchia R, Veronesi U. Surgical technique of intraoperative radiotherapy in conservative treatment of limited-stage breast cancer. Arch Surg. 2002 Jun;137(6):737-40. doi: 10.1001/archsurg.137.6.737.

Veronesi U, Gatti G, Luini A, Intra M, Orecchia R, Borgen P, Zelefsky M, McCormick B, Sacchini V. Intraoperative radiation therapy for breast cancer: technical notes. Breast J. 2003 Mar-Apr;9(2):106-12. doi: 10.1046/j.1524-4741.2003.09208.x.

Ciocca M, Orecchia R, Garibaldi C, Rondi E, Luini A, Gatti G, Intra M, Veronesi P, Lazzari R, Tosi G, Veronesi U. In vivo dosimetry using radiochromic films during intraoperative electron beam radiation therapy in early-stage breast cancer. Radiother Oncol. 2003 Dec;69(3):285-9. doi: 10.1016/j.radonc.2003.09.001.

Orecchia R, Ciocca M, Lazzari R, Garibaldi C, Leonardi MC, Luini A, Intra M, Gatti G, Veronesi P, Petit JI, Veronesi U. Intraoperative radiation therapy with electrons (ELIOT) in early-stage breast cancer. Breast. 2003 Dec;12(6):483-90. doi: 10.1016/s0960-9776(03)00156-5.

Veronesi U, Gatti G, Luini A, Intra M, Ciocca M, Sanchez D, Zurrida S, Navarro S, Orecchia R. Full-dose intraoperative radiotherapy with electrons during breast-conserving surgery. Arch Surg. 2003 Nov;138(11):1253-6. doi: 10.1001/archsurg.138.11.1253.

Intra M, Leonardi MC, Gatti G, Vento AR, Ciocca M, Veronesi P, Bassani G, Dos Santos GR, Rodriguez J, Luini A, Orecchia R, Veronesi U. Intraoperative radiotherapy during breast conserving surgery in patients previously treated with radiotherapy for Hodgkin's disease. Tumori. 2004 Jan-Feb;90(1):13-6. doi: 10.1177/030089160409000104.

Intra M, Orecchia R, Veronesi U. Intraoperative radiotherapy: the debate continues. Lancet Oncol. 2004 Jun;5(6):340. doi: 10.1016/S1470-2045(04)01489-5. No abstract available.

Orecchia R, Ciocca M, Tosi G, Franzetti S, Luini A, Gatti G, Veronesi U. Intraoperative electron beam radiotherapy (ELIOT) to the breast: a need for a quality assurance programme. Breast. 2005 Dec;14(6):541-6. doi: 10.1016/j.breast.2005.08.038. Epub 2005 Oct 19.

Intra M, Leonardi C, Luini A, Veronesi P, Gennari R, Gatti G, Ciocca M, Soteldo J, Bassi F, Venturino M, Orecchia R, Veronesi U. Full-dose intraoperative radiotherapy with electrons in breast surgery: broadening the indications. Arch Surg. 2005 Oct;140(10):936-9. doi: 10.1001/archsurg.140.10.936.

Luini A, Orecchia R, Gatti G, Intra M, Ciocca M, Galimberti V, Veronesi P, Santos GR, Gilardi D, Veronesi U. The pilot trial on intraoperative radiotherapy with electrons (ELIOT): update on the results. Breast Cancer Res Treat. 2005 Sep;93(1):55-9. doi: 10.1007/s10549-005-3782-1.

Orecchia R, Luini A, Veronesi P, Ciocca M, Franzetti S, Gatti G, Veronesi U. Electron intraoperative treatment in patients with early-stage breast cancer: data update. Expert Rev Anticancer Ther. 2006 Apr;6(4):605-11. doi: 10.1586/14737140.6.4.605.

Petit JY, Veronesi U, Orecchia R, Luini A, Rey P, Intra M, Didier F, Martella S, Rietjens M, Garusi C, DeLorenzi F, Gatti G, Leon ME, Casadio C. Nipple-sparing mastectomy in association with intra operative radiotherapy (ELIOT): A new type of mastectomy for breast cancer treatment. Breast Cancer Res Treat. 2006 Mar;96(1):47-51. doi: 10.1007/s10549-005-9033-7. Epub 2005 Oct 27.

Calvo FA, Meirino RM, Orecchia R. Intraoperative radiation therapy first part: rationale and techniques. Crit Rev Oncol Hematol. 2006 Aug;59(2):106-15. doi: 10.1016/j.critrevonc.2005.11.004. Epub 2006 Jul 14.

Calvo FA, Meirino RM, Orecchia R. intraoperative radiation therapy part 2. Clinical results. Crit Rev Oncol Hematol. 2006 Aug;59(2):116-27. doi: 10.1016/j.critrevonc.2006.04.004. Epub 2006 Jul 21.

Bernier J, Viale G, Orecchia R, Ballardini B, Richetti A, Bronz L, Franzetti-Pellanda A, Intra M, Veronesi U. Partial irradiation of the breast: Old challenges, new solutions. Breast. 2006 Aug;15(4):466-75. doi: 10.1016/j.breast.2005.11.012. Epub 2006 Jan 24.

Ciocca M, Piazzi V, Lazzari R, Vavassori A, Luini A, Veronesi P, Galimberti V, Intra M, Guido A, Tosi G, Veronesi U, Orecchia R. Real-time in vivo dosimetry using micro-MOSFET detectors during intraoperative electron beam radiation therapy in early-stage breast cancer. Radiother Oncol. 2006 Feb;78(2):213-6. doi: 10.1016/j.radonc.2005.11.011. Epub 2005 Dec 15.

Luini A, Gatti G, Zurrida S, Talakhadze N, Brenelli F, Gilardi D, Paganelli G, Orecchia R, Cassano E, Viale G, Sangalli C, Ballardini B, dos Santos GR, Veronesi U. The evolution of the conservative approach to breast cancer. Breast. 2007 Apr;16(2):120-9. doi: 10.1016/j.breast.2006.11.001.

Ciocca M, Pedroli G, Orecchia R, Guido A, Cattani F, Cambria R, Veronesi U. Radiation survey around a Liac mobile electron linear accelerator for intraoperative radiation therapy. J Appl Clin Med Phys. 2009 Apr 28;10(2):131-138. doi: 10.1120/jacmp.v10i2.2950.

Orecchia R, Ivaldi GB, Leonardi MC. Integrated breast conservation and intraoperative radiation therapy. Breast. 2009 Oct;18 Suppl 3:S98-102. doi: 10.1016/S0960-9776(09)70283-8.

Petit JY, Veronesi U, Orecchia R, Rey P, Martella S, Didier F, Viale G, Veronesi P, Luini A, Galimberti V, Bedolis R, Rietjens M, Garusi C, De Lorenzi F, Bosco R, Manconi A, Ivaldi GB, Youssef O. Nipple sparing mastectomy with nipple areola intraoperative radiotherapy: one thousand and one cases of a five years experience at the European institute of oncology of Milan (EIO). Breast Cancer Res Treat. 2009 Sep;117(2):333-8. doi: 10.1007/s10549-008-0304-y. Epub 2009 Jan 17.

Galimberti V, Ciocca M, Leonardi MC, Zanagnolo V, Paola B, Manuela S, Sahium RC, Lazzari R, Gentilini O, Peccatori F, Veronesi U, Orecchia R. Is electron beam intraoperative radiotherapy (ELIOT) safe in pregnant women with early breast cancer? In vivo dosimetry to assess fetal dose. Ann Surg Oncol. 2009 Jan;16(1):100-5. doi: 10.1245/s10434-008-0172-z. Epub 2008 Oct 21.

Rampinelli C, Bellomi M, Ivaldi GB, Intra M, Raimondi S, Meroni S, Orecchia R, Veronesi U. Assessment of pulmonary fibrosis after radiotherapy (RT) in breast conserving surgery: comparison between conventional external beam RT (EBRT) and intraoperative RT with electrons (ELIOT). Technol Cancer Res Treat. 2011 Aug;10(4):323-9. doi: 10.7785/tcrt.2012.500209.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Orecchia R, Veronesi U, Maisonneuve P, Galimberti VE, Lazzari R, Veronesi P, Jereczek-Fossa BA, Cattani F, Sangalli C, Luini A, Caldarella P, Venturino M, Sances D, Zurrida S, Viale G, Leonardi MC, Intra M. Intraoperative irradiation for early breast cancer (ELIOT): long-term recurrence and survival outcomes from a single-centre, randomised, phase 3 equivalence trial. Lancet Oncol. 2021 May;22(5):597-608. doi: 10.1016/S1470-2045(21)00080-2. Epub 2021 Apr 9.

Veronesi U, Orecchia R, Maisonneuve P, Viale G, Rotmensz N, Sangalli C, Luini A, Veronesi P, Galimberti V, Zurrida S, Leonardi MC, Lazzari R, Cattani F, Gentilini O, Intra M, Caldarella P, Ballardini B. Intraoperative radiotherapy versus external radiotherapy for early breast cancer (ELIOT): a randomised controlled equivalence trial. Lancet Oncol. 2013 Dec;14(13):1269-77. doi: 10.1016/S1470-2045(13)70497-2. Epub 2013 Nov 11.

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