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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
  Purpose

Aim of the study is to evaluate toxicity in breast cancer patients treated with two different doses of Intra Operative Radiotherapy


Condition Intervention Phase
Breast Neoplasms
Toxicity
 Radiation: 21 Gy radiation
Radiation: 18 Gy radiation
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tolerance Evaluation of Exclusive Intraoperative Radiation Therapy at Different Doses for Breast Cancer Conservative Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute for Cancer Research, Italy:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 40
Study Start Date: April 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IORT 21 Gy
Single fraction 21 Gy Intraoperative Radiation Therapy for breast tumors with diameter between 10 and 25 mm
 Radiation: 21 Gy radiation
21 Gy radiation using electrons produced with mobile linear accelerator (energies ranging from 4 to 10 MeV)
Experimental: IORT 18 Gy
Single fraction 18 Gy Intra Operative Radiation Therapy in breast tumors smaller than 10 mm.
 Radiation: 18 Gy radiation
18 Gy radiation using electrons produced with mobile linear accelerator (energies ranging from 4 to 10 MeV)

  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01276938

Contacts
Contact: Marina Guenzi, MD +390105600366 marina.guenzi@istge.it
Contact: Renzo Corvò, MD +390105600365 Renzo.Corvo@unige.it

Locations
Italy
National Institute for Cancer Research (Istituto Nazionale per la Ricerca sul Cancro) Recruiting
Genova, Italy, 16132
Contact: Marina Guenzi, MD     +390105600366     marina.guenzi@istge.it    
Contact: Renzo Corvò, MD     +390105600365     Renzo.Corvo@unige.it    
Principal Investigator: Marina Guenzi, MD            
Sponsors and Collaborators
National Institute for Cancer Research, Italy
Investigators
Principal Investigator: Marina Guenzi, MD National Institute for Cancer Research
  More Information

No publications provided

Responsible Party: Marina Guenzi, MD, National Institute for Cancer Research, Italy
ClinicalTrials.gov Identifier: NCT01276938     History of Changes
Other Study ID Numbers: istgeiort
Study First Received: January 13, 2011
Last Updated: January 13, 2011
Health Authority: Italy: Ministry of Health

Keywords provided by National Institute for Cancer Research, Italy:
Breast cancer
Intra Operative Radiation Therapy
Toxicity

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013