Exclusive Intraoperative Radiation Therapy for Breast Cancer
Conditions
Breast Neoplasms - Toxicity
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
Breast cancer, Intra Operative Radiation Therapy, Toxicity
Study Type
Interventional
Study Phase
Phase 2/Phase 3
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: 21 Gy radiation Type: Radiation
Name: 18 Gy radiation Type: Radiation
Overall Status
Recruiting
Summary
Aim of the study is to evaluate toxicity in breast cancer patients treated with two different doses of Intra Operative Radiotherapy
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 85 Years
Minimum Age: 45 Years
Gender: Female
Criteria: 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
Location
National Institute for Cancer Research (Istituto Nazionale per la Ricerca sul Cancro)
Genova, Italy
Status: Recruiting
Contact: Marina Guenzi, MD - +390105600366 - marina.guenzi@istge.it
Start Date
April 2009
Completion Date
September 2011
Sponsors
National Institute for Cancer Research, Italy
Source
National Institute for Cancer Research, Italy
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page