MedTrace Logo

Internal Radiation Therapy After Lumpectomy in Treating Women With Ductal Carcinoma in Situ

NCT00290654 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2017-12-28

Study results available
· View outcomes & findings →

Summary

RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving internal radiation therapy using a special radiation therapy device may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well internal radiation therapy after lumpectomy works in treating women with ductal carcinoma in situ.

Conditions

Interventions

DRUG

Tamoxifen

Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient

PROCEDURE

Lumpectomy

A standard lumpectomy will be performed with an attempt to remove at least 1 cm of gross margin around the DCIS.

RADIATION

brachytherapy

Treatment will be given in 10 fractions of 3.4 Gy per fraction twice a day, with a minimum of 6 hours between fractions. In general, brachytherapy will start between 2 - 5 days of implant. All treatments will be done using a commercially available HDR and 192Ir radioactive sources.

Sponsors & Collaborators

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • Todd M. Tuttle, MD · Masonic Cancer Center, University of Minnesota

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-12-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United States

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 NCT00290654 on ClinicalTrials.gov