Randomized Trial on Intraoperative Radiotherapy Full Dose Vs External Radiotherapy

NCT01849133 | Completed

• 1 other identifier: IEO S65/500
• Study Type: interventional
• Target: 1,305
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the efficacy of exclusive intraoperative radiation therapy after conserving surgery in early-stage breast cancer compared with whole breast radiotherapy. The primary outcome was the rate of ipsilateral true recurrence ( any recurrence at or close to primary tumor bed) and new ipsilateral tumors ( any recurrence occurring in quadrants other than the previous one) and the recurrence free survival.

Conditions

Carcinoma Breast

Keywords

Breast cancer; conservative surgery; intraoperative radiation therapy; mobile linear accelerator

Outcome Measures

Primary Outcomes (1)

• Number of local relapses

  local relapse of disease and ipsilateral second primary

  5 YEARS

Study Arms (2)

ELIOT

EXPERIMENTAL

intraoperative radiotherapy

Radiation: intraoperative radiotherapy

EXTERNAL RT

ACTIVE COMPARATOR

external fractionated radiotherapy

Radiation: external fractionated radiotherapy

Interventions

external fractionated radiotherapy RADIATION

conventional external beam radiotherapy

EXTERNAL RT

intraoperative radiotherapy RADIATION

Intraoperative radiotherapy (IORT). Total delivered dose 21Gy (Gray), 90% isodose

ELIOT

Eligibility Criteria

• Age: 48 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 48 and \< 75
• Clinical mammographic/ultrasound diagnosis of unicentric carcinoma, with ultrasound diameter ≤2.5 cm. Advisable, but not mandatory, the execution of mammoscintigraphy with MDP-99mTc (Methyl diphosphonate technetium-99m) : this procedure allows the bone staging and the mapping of eventual multi-focality/multi-centricity of the breast neoplasm.
• No previous therapy (biopsy included) for breast cancer in other Institutions.
• Patients with non-palpable lesions will undergo preoperative centering and stereotactic and/or ultrasound-guided cytology (the execution of this last procedure is not mandatory).
• Adequate information to the patient and informed consent.

You may not qualify if:

• Ductal or lobular non-infiltrating carcinoma.
• Paget disease.
• Tumor in close proximity to the skin.
• Tumor in the axillary tail.
• Documented multi-centricity/multi-focality of the tumor.
• Patients who underwent excisional biopsy in other Institutions.
• Histology different from carcinoma.
• Personal anamnesis positive for malignancy (basocellular carcinoma, in situ carcinoma of the cervix, contralateral breast cancer free of disease after 15 years of follow-up excluded).
• General contraindications to regular follow-up or radiotherapy.

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, Italy

Location

Related Publications (27)

• 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.

  PMID: 11677104 BACKGROUND

• 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.

  PMID: 11505618 BACKGROUND

• 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.

  PMID: 12049547 BACKGROUND

• 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.

  PMID: 12603383 BACKGROUND

• 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.

  PMID: 14644488 BACKGROUND

• 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.

  PMID: 14659125 BACKGROUND

• 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.

  PMID: 14609877 BACKGROUND

• 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.

  PMID: 15143964 BACKGROUND

• 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.

  PMID: 15172353 BACKGROUND

• 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.

  PMID: 16242331 BACKGROUND

• 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.

  PMID: 16230541 BACKGROUND

• 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.

  PMID: 16184459 BACKGROUND

• 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.

  PMID: 16613547 BACKGROUND

• 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.

  PMID: 16261402 BACKGROUND

• 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.

  PMID: 16844383 BACKGROUND

• 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.

  PMID: 16859922 BACKGROUND

• 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.

  PMID: 16439129 BACKGROUND

• 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.

  PMID: 16359743 BACKGROUND

• 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.

  PMID: 17403449 BACKGROUND

• 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.

  PMID: 19458597 BACKGROUND

• 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.

  PMID: 19914553 BACKGROUND

• 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.

  PMID: 19152026 BACKGROUND

• 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.

  PMID: 18941842 BACKGROUND

• 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.

  PMID: 21728389 BACKGROUND

• 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.

  PMID: 16934611 RESULT

• 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.

  PMID: 33845035 DERIVED

• 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.

  PMID: 24225155 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• UMBERTO VERONESI, PROF

  European Institute of Oncology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2013
• First Posted: May 8, 2013
• Study Start: November 1, 2000
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 8, 2013

Record last verified: 2013-05

Locations

IT (1)