Status:
COMPLETED
Randomized Trial on Intraoperative Radiotherapy Full Dose Vs External Radiotherapy
Lead Sponsor:
European Institute of Oncology
Conditions:
Carcinoma Breast
Eligibility:
FEMALE
48-75 years
Phase:
NA
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. Th...
Detailed Description
The ELIOT trial is a prospective single center randomised phase III trial which compared intraoperative radiotherapy with electrons to the tumor bed with conventional scheme of whole breast external b...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
1305 Patients enrolled
Trial Details
Trial ID
NCT01849133
Start Date
November 1 2000
End Date
December 1 2012
Last Update
May 8 2013
Active Locations (1)
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1
European Institute of Oncology
Milan, Italy