Partial Breast Irradiation With Interstitial High Dose Rate Brachytherapy

NCT00499057 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2014-12-23

No results posted yet for this study

Summary

Partial breast irradiation (PBI) is becoming more widespread in the treatment of early breast cancer in patients at low risk of relapse as pathological and clinical findings have demonstrated that most breast cancer recurrences after BCS occur close to the tumour bed. In our phase II prospective study PBI is administered with high-dose-rate brachytherapy in patients with low-risk early-stage breast cancer. Patients receive 4 Gy twice a day for 4 days (total dose 32 Gy).

Conditions

Interventions

RADIATION

interstitial high dose-rate brachytherapy, PBI

Single arm study Treatment schedule is 4 Gy twice a day, with a time relapse of at least 6 hours between each fraction, for four days, for a total dose 32 Gy.

Sponsors & Collaborators

  • University Of Perugia

    lead OTHER

Principal Investigators

  • Cynthia Aristei, Prof. M.D. · University Of Perugia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-08-31
Primary Completion
2015-08-31
Completion
2016-08-31

Countries

  • Italy

Study Locations

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Entities

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 NCT00499057 on ClinicalTrials.gov