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Tolerance Evaluation of Exclusive Intraoperative Radiation Therapy at Different Doses for Breast Cancer Conservative Treatment


Phase 2/Phase 3
45 Years
85 Years
Open (Enrolling)
Female
Breast Neoplasms, Toxicity

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Trial Information

Tolerance Evaluation of Exclusive Intraoperative Radiation Therapy at Different Doses for Breast Cancer Conservative Treatment


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Early toxicity

Outcome Description:

Assessment of early toxicity using modified RTOG scale

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Marina Guenzi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Institute for Cancer Research

Authority:

Italy: Ministry of Health

Study ID:

istgeiort

NCT ID:

NCT01276938

Start Date:

April 2009

Completion Date:

September 2011

Related Keywords:

  • Breast Neoplasms
  • Toxicity
  • Breast cancer
  • Intra Operative Radiation Therapy
  • Toxicity
  • Breast Neoplasms
  • Neoplasms

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