CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,305 enrolled
Drug / intervention
external fractionated radiotherapy +1 moreradiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01849133
NCT01849133N/ACompleted
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Randomized Clinical Trial: Comparison Between Quadrantectomy Followed by External Fractionated Radiotherapy and Quadrantectomy Associated With Intraoperative Radiotherapy in Women >= 48 Years of Age Affected by Early-stage Breast Carcinoma.

European Institute of Oncology·interventional·Posted May 8, 2013·Updated May 8, 2013

In Brief

A clinical study evaluating external fractionated radiotherapy and intraoperative radiotherapy for Carcinoma Breast. Completed, enrolled 1,305 participants across 1 site.

Detailed Summary

The purpose of this study is to investigate the efficacy of exclusive intraoperative radiation therapy after conserving surgery in early-stage breast cancer compared with whole breast radiotherapy. The primary outcome was the rate of ipsilateral true recurrence ( any recurrence at or close to primary tumor bed) and new ipsilateral tumors ( any recurrence occurring in quadrants other than the previous one) and the recurrence free survival.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma Breast
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 8, 2013
Enrollment StartNov 1, 2000
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 12.1 yearsPosted 13.2 years ago

Interventions

external fractionated radiotherapyradiation

conventional external beam radiotherapy

intraoperative radiotherapyradiation

Intraoperative radiotherapy (IORT). Total delivered dose 21Gy (Gray), 90% isodose