Exclusive Intraoperative Radiation Therapy for Breast Cancer

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Status and phase: Completed; Phase 3; Phase 2

Conditions: Breast Neoplasms; Toxicity

Treatments: Radiation: 21 Gy radiation; Radiation: 18 Gy radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT01276938

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Details and patient eligibility

About

Aim of the study is to evaluate toxicity in breast cancer patients treated with two different doses of Intra Operative Radiotherapy

Enrollment: 40 patients

Sex: Female

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non lobular epithelial breast carcinoma, excised with standard quadrantectomy
• Age ≥ 45 and < 85
• Tumor major diameter ≤ 2.5 cm
• Negative surgical margins (≥ 5 mm)
• Willingness to undergo follow up examinations
• Willingness to undergo imaging examinations (MRI, mammograms, ultrasonography)
• Signed informed consent

Exclusion criteria

• Ductal carcinoma in situ or lobular carcinoma
• Extensive intraductal component (greater than 25%) or intraductal carcinoma with microinvasion
• Serious concomitant disease or any disorder or condition (such as psychiatric or addictive disorders) that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
• Pregnancy or lactation at the time of enrolment proposal (if necessary, during the trial patients must use effective contraceptive device)
• Collagen vascular disorders

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

IORT 21 Gy

Active Comparator group

Description:

Single fraction 21 Gy Intraoperative Radiation Therapy for breast tumors with diameter between 10 and 25 mm

Treatment:

Radiation: 21 Gy radiation

IORT 18 Gy

Experimental group

Description:

Single fraction 18 Gy Intra Operative Radiation Therapy in breast tumors smaller than 10 mm.

Treatment:

Radiation: 18 Gy radiation