Randomized Trial on Intraoperative Radiotherapy Full Dose Vs External Radiotherapy

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.

Sex

Female

Minimum age

48 Years

Maximum age

75 Years

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

• BACKGROUNDVeronesi 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
• BACKGROUNDGatzemeier 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
• BACKGROUNDIntra 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
• BACKGROUNDVeronesi 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
• BACKGROUNDCiocca 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
• BACKGROUNDOrecchia 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.