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Randomized Trial on Intraoperative Radiotherapy Full Dose Vs External Radiotherapy

NCT01849133 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1305

Last updated 2013-05-08

No results posted yet for this study

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.

Conditions

  • Carcinoma Breast

Interventions

RADIATION

external fractionated radiotherapy

conventional external beam radiotherapy

RADIATION

intraoperative radiotherapy

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

Sponsors & Collaborators

  • European Institute of Oncology

    lead OTHER

Principal Investigators

  • UMBERTO VERONESI, PROF · European Institute of Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
48 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-11-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01849133 on ClinicalTrials.gov