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Dose Optimization for Pulsed-dose-rate (PDR)/High-dose-rate (HDR) Brachytherapy Alone for Early Breast Cancer

NCT01175694 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2010-08-20

No results posted yet for this study

Summary

Accelerated partial breast irradiation (APBI) leads to a equivalent local control rate with lower toxicity as external beam irradiation (EBI) after breast conserving surgery (BCS) in a highly selected subgroup of patients with low risk invasive carcinoma and low risk duct carcinoma in-situ (DCIS). The goal of this trial is to assess the role of a modified dose of pulsed-dose-rate (PDR) and high-dose-rate (HDR) brachytherapy alone as Accelerated Partial Breast Irradiation (APBI) in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning local failure (all ipsilateral local recurrences), in particular regarding the local recurrences, the toxicity and for the cosmetic result. It is a phase II study. According to study protocol altogether 200 female patients will be treated.

Conditions

Interventions

RADIATION

Interstitial multicatheter brachytherapy

Interstitial PDR- and HDR-brachytherapy up to 50 Gy-eq

Sponsors & Collaborators

  • University Hospital Erlangen

    lead OTHER

Principal Investigators

  • Vratislav Strnad, MD, Prof. · University Hospital Erlangen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2012-06-30
Completion
2015-01-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT01175694 on ClinicalTrials.gov