Exclusive Intraoperative Radiation Therapy for Breast Cancer

Breast Neoplasms Clinical Trial

Official title:

Tolerance Evaluation of Exclusive Intraoperative Radiation Therapy at Different Doses for Breast Cancer Conservative Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01276938
• Other study ID #: istgeiort
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 13, 2011
• Last updated: May 23, 2017
• Start date: April 2009
• Est. completion date: September 2011

Study information

• Verified date: September 2010
• Source: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Toxicity

Intervention

Radiation:
• 21 Gy radiation
21 Gy radiation using electrons produced with mobile linear accelerator (energies ranging from 4 to 10 MeV)
• 18 Gy radiation
18 Gy radiation using electrons produced with mobile linear accelerator (energies ranging from 4 to 10 MeV)

Locations

Country	Name	City	State
Italy	IRCCS AOU San Martino- IST	Genoa

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early toxicity	Assessment of early toxicity using modified RTOG scale	6 months
Primary	Late toxicity	Assessment of late toxicity using modified LENT scale	5 years
Primary	Cosmetic outcome	Assessment of cosmetic outcome according to semi-objective criteria	5 years
Secondary	Local Relapse Free Survival (LRFS)	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	10 years
Secondary	Disease Free Survival (DFS)	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	10 years