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Exclusive Intraoperative Radiation Therapy for Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01276938
First Posted: January 14, 2011
Last Update Posted: May 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
January 13, 2011
January 14, 2011
May 24, 2017
April 2009
September 2011   (Final data collection date for primary outcome measure)
  • Early toxicity [ Time Frame: 6 months ]
    Assessment of early toxicity using modified RTOG scale
  • Late toxicity [ Time Frame: 5 years ]
    Assessment of late toxicity using modified LENT scale
  • Cosmetic outcome [ Time Frame: 5 years ]
    Assessment of cosmetic outcome according to semi-objective criteria
Same as current
Complete list of historical versions of study NCT01276938 on ClinicalTrials.gov Archive Site
  • Local Relapse Free Survival (LRFS) [ Time Frame: 10 years ]
    Local recurrence rate will be continuously monitored in order to stop the trial in case results will be consistently worse than expected according to literature data
  • Disease Free Survival (DFS) [ Time Frame: 10 years ]
    Disease Free Survival will be continuously monitored in order to stop the trial in case results will be consistently worse than expected according to literature data
Same as current
Not Provided
Not Provided
 
Exclusive Intraoperative Radiation Therapy for Breast Cancer
Tolerance Evaluation of Exclusive Intraoperative Radiation Therapy at Different Doses for Breast Cancer Conservative Treatment
Aim of the study is to evaluate toxicity in breast cancer patients treated with two different doses of Intra Operative Radiotherapy
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Breast Neoplasms
  • Toxicity
  • Radiation: 21 Gy radiation
    21 Gy radiation using electrons produced with mobile linear accelerator (energies ranging from 4 to 10 MeV)
  • Radiation: 18 Gy radiation
    18 Gy radiation using electrons produced with mobile linear accelerator (energies ranging from 4 to 10 MeV)
  • Active Comparator: IORT 21 Gy
    Single fraction 21 Gy Intraoperative Radiation Therapy for breast tumors with diameter between 10 and 25 mm
    Intervention: Radiation: 21 Gy radiation
  • Experimental: IORT 18 Gy
    Single fraction 18 Gy Intra Operative Radiation Therapy in breast tumors smaller than 10 mm.
    Intervention: Radiation: 18 Gy radiation
Guenzi M, Fozza A, Timon G, Belgioia L, Vidano G, Cavagnetto F, Agostinelli S, Gusinu M, Carli F, Cafiero F, Friedman D, Canavese G, Corvò R. A two-step selection of breast cancer patients candidates for exclusive IORT with electrons: a mono-institutional experience. Anticancer Res. 2012 Apr;32(4):1533-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
September 2011
September 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
45 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT01276938
istgeiort
Yes
Not Provided
Not Provided
Marina Guenzi, MD, National Institute for Cancer Research, Italy
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Not Provided
Principal Investigator: Marina Guenzi, MD IRCCS AOU SanMartino IST
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP