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Exclusive Intraoperative Radiation Therapy for Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
ClinicalTrials.gov Identifier:
NCT01276938
First received: January 13, 2011
Last updated: May 23, 2017
Last verified: September 2010
  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
Intervention Model: Parallel Assignment
Masking: No masking
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:


Further study details as provided by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 40
Study Start Date: April 2009
Study Completion Date: September 2011
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   (Adult, Senior)
Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01276938

Locations
Italy
IRCCS AOU San Martino- IST
Genoa, Italy, 16132
Sponsors and Collaborators
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Investigators
Principal Investigator: Marina Guenzi, MD IRCCS AOU SanMartino IST
  More Information

Publications:
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: May 23, 2017

Keywords provided by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy:
Breast cancer
Intra Operative Radiation Therapy
Toxicity

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

ClinicalTrials.gov processed this record on June 23, 2017