NCT01276938

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

May 24, 2017

Status Verified

September 1, 2010

Enrollment Period

2.4 years

First QC Date

January 13, 2011

Last Update Submit

May 23, 2017

Conditions

Breast NeoplasmsToxicity

Keywords

Breast cancerIntra Operative Radiation TherapyToxicity

Outcome Measures

Primary Outcomes (3)

  • Early toxicity

    Assessment of early toxicity using modified RTOG scale

    6 months

  • Late toxicity

    Assessment of late toxicity using modified LENT scale

    5 years

  • Cosmetic outcome

    Assessment of cosmetic outcome according to semi-objective criteria

    5 years

Secondary Outcomes (2)

  • Local Relapse Free Survival (LRFS)

    10 years

  • Disease Free Survival (DFS)

    10 years

Study Arms (2)

IORT 21 Gy

ACTIVE COMPARATOR

Single fraction 21 Gy Intraoperative Radiation Therapy for breast tumors with diameter between 10 and 25 mm

Radiation: 21 Gy radiation

IORT 18 Gy

EXPERIMENTAL

Single fraction 18 Gy Intra Operative Radiation Therapy in breast tumors smaller than 10 mm.

Radiation: 18 Gy radiation

Interventions

21 Gy radiationRADIATION

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

IORT 21 Gy
18 Gy radiationRADIATION

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

IORT 18 Gy

Eligibility Criteria

Age45 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS AOU San Martino- IST

Genoa, 16132, Italy

Location

Related Publications (2)

  • Guenzi M, Fozza A, Timon G, Belgioia L, Vidano G, Cavagnetto F, Agostinelli S, Gusinu M, Carli F, Cafiero F, Friedman D, Canavese G, Corvo 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.

    PMID: 22493397BACKGROUND

  • Bonzano E, Belgioia L, Fregatti P, Friedman D, Agostinelli S, Cavagnetto F, Bevegni M, Corvo R, Guenzi M. Tumor Size-driven Dose of Intraoperative Radiotherapy for Breast Cancer: 18 Gy Versus 21 Gy. Anticancer Res. 2018 Sep;38(9):5475-5479. doi: 10.21873/anticanres.12880.

    PMID: 30194205DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Marina Guenzi, MD

    IRCCS AOU SanMartino IST

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 13, 2011

First Posted

January 14, 2011

Study Start

April 1, 2009

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

May 24, 2017

Record last verified: 2010-09

Locations

IT(1)