Exclusive Intraoperative Radiation Therapy for Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-09-30

Brief Summary

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

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Detailed Description

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Conditions

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Breast Neoplasms Toxicity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IORT 21 Gy

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

Group Type ACTIVE_COMPARATOR

21 Gy radiation

Intervention Type RADIATION

21 Gy radiation using electrons produced with mobile linear accelerator (energies ranging from 4 to 10 MeV)

IORT 18 Gy

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

Group Type EXPERIMENTAL

18 Gy radiation

Intervention Type RADIATION

18 Gy radiation using electrons produced with mobile linear accelerator (energies ranging from 4 to 10 MeV)

Interventions

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21 Gy radiation

21 Gy radiation using electrons produced with mobile linear accelerator (energies ranging from 4 to 10 MeV)

Intervention Type RADIATION

18 Gy radiation

18 Gy radiation using electrons produced with mobile linear accelerator (energies ranging from 4 to 10 MeV)

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No