ClinicalTrials.Veeva

Menu

Exclusive Intraoperative Radiation Therapy for Breast Cancer

I

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
istgeiort

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)

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems