Exclusive Intraoperative Radiation Therapy for Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by National Institute for Cancer Research, Italy.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute for Cancer Research, Italy
ClinicalTrials.gov Identifier:
NCT01276938
First received: January 13, 2011
Last updated: NA
Last verified: September 2010
History: No changes posted

January 13, 2011
January 13, 2011
April 2009
September 2011   (final data collection date for primary outcome measure)
  • Early toxicity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Assessment of early toxicity using modified RTOG scale
  • Late toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Assessment of late toxicity using modified LENT scale
  • Cosmetic outcome [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Assessment of cosmetic outcome according to semi-objective criteria
Same as current
No Changes Posted
  • Local Relapse Free Survival (LRFS) [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
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
Female
45 Years to 85 Years
No
Contact: Marina Guenzi, MD +390105600366 marina.guenzi@istge.it
Contact: Renzo Corvò, MD +390105600365 Renzo.Corvo@unige.it
Italy
 
NCT01276938
istgeiort
Yes
Marina Guenzi, MD, National Institute for Cancer Research, Italy
National Institute for Cancer Research, Italy
Not Provided
Principal Investigator: Marina Guenzi, MD National Institute for Cancer Research
National Institute for Cancer Research, Italy
September 2010

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