Intensity Modulated Radiotherapy for Breast Cancer (IMRT)

August 8, 2017 updated by: Washington University School of Medicine

Intensity Modulated Radiation Therapy for Breast Cancer: A Phase I Feasibility Study

This study delivers radiation therapy to any residual breast tissue and the chest wall plus lymph node areas around the breast. These lymph node areas are under the arm, around the collar bone, and under the sternum (breastbone).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

IMRT treatment uses a computer-controlled x-ray (CT) to deliver radiation beams at several different angles and strengths to deliver precise doses to the regions at risk for recurrence of breast cancer while reducing or sparing the dose to critical structures (heart, lungs) and nearby normal tissue.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female gender
  • Age ≥ 18 years
  • Invasive primary female breast cancer
  • Pathologically proven regional nodal metastasis
  • Status post mastectomy or partial mastectomy with an assessment of axillary nodes via sentinel lymph node biopsy and/or axillary lymph node dissection.
  • Signed study specific consent form

Exclusion Criteria:

  • Distant metastasis
  • Currently Pregnant
  • Psychiatric or addictive disorders that preclude informed consent
  • Time from initial diagnosis to the start of radiation therapy > one year
  • Estimated life expectancy judged to be < one year
  • Prior radiation to the ipsilateral breast or chest wall
  • Primary breast cancer is lymphoma or sarcoma
  • Patients being treated with concurrent chemotherapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IMRT
The prescribed dose for all patients will be 5040 cGy in 28 fractions. Patients will receive external beam treatment once a day, five days a week for approximately five and a half weeks.
Radiation: IMRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the feasibility of adjuvant comprehensive radiation therapy via IMRT with daily set-up position verified using 3D verification
Time Frame: Within 1 year of protocol registration

The study will be deemed infeasible if greater than 10% of enrolled patients have at least one of the following outcomes:

  1. Patient cannot be given the treatment because her anatomy is such that a dosimetrically satisfactory treatment plan cannot be devised for her.
  2. Within 1 year of protocol registration, the patient develops radiation pneumonitis toxicity of greater than or equal to grade 3 by CTCAE scales.
  3. Within 1 year of protocol registration, the patient develops any local or regional breast cancer recurrence.
  4. Within 1 year of protocol registration, the patient dies from causes judged to be related to her treatment.
Within 1 year of protocol registration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the rate and severity of both acute and late cutaneous toxicity
Time Frame: 6-8 months following completion of treatment and 12-14 months following completion of treatment
6-8 months following completion of treatment and 12-14 months following completion of treatment
Evaluate the rate and severity of late subcutaneous fibrosis
Time Frame: 6-8 months following completion of treatment and 12-14 months following completion of treatment
6-8 months following completion of treatment and 12-14 months following completion of treatment
Evaluate the rate of radiation pneumonitis
Time Frame: 6-8 weeks following completion of treatment, 3-4 months following completion of treatment, 6-8 months following completion of treatment, and 12-14 months following completion of treatment
6-8 weeks following completion of treatment, 3-4 months following completion of treatment, 6-8 months following completion of treatment, and 12-14 months following completion of treatment
Evaluate ipsilateral upper quadrant function
Time Frame: Pretreatment and 3-4 months following completion of treatment
For patients who receive physical therapy, objective measures of the rotator cuff, bursa, and joint space will be evaluated by diagnostic ultrasound if medically indicated.
Pretreatment and 3-4 months following completion of treatment
Evaluate patient quality of life
Time Frame: Pretreatment, 6-8 months following completion of treatment, and 12-14 months following completion of treatment
Pretreatment, 6-8 months following completion of treatment, and 12-14 months following completion of treatment
Evaluate local-regional control rates
Time Frame: 12-14 months following completion of radiation therapy
12-14 months following completion of radiation therapy
Evaluate patient set-up reproducibility in breast cancer patients treated with IMRT using daily 3D position verification
Time Frame: 12-14 months following completion of treatment
12-14 months following completion of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Imran Zoberi, MD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2008

Primary Completion (Actual)

August 8, 2016

Study Completion (Actual)

August 8, 2016

Study Registration Dates

First Submitted

January 4, 2008

First Submitted That Met QC Criteria

January 14, 2008

First Posted (Estimate)

January 15, 2008

Study Record Updates

Last Update Posted (Actual)

August 10, 2017

Last Update Submitted That Met QC Criteria

August 8, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-1077 / 201106403

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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