Radiation Therapy Planning Techniques in Reducing Damage to Normal Tissue in Women Undergoing Breast-Conserving Surgery for Ductal Carcinoma of the Breast

June 25, 2013 updated by: Royal Marsden NHS Foundation Trust

WILL MULTIFUNCTIONAL MAGNETIC RESONANCE TECHNIQUES, DETAILED HISTOPATHOLOGICAL ANALYSIS AND PRONE TREATMENT POSITION IMPROVE ACCURACY OF TARGET VOLUME LOCALISATION & DEFINITION AND REDUCE EXPOSURE OF NORMAL TISSUES IN BREAST RADIOTHERAPY?

RATIONALE: Diagnostic procedures, such as multifunctional magnetic resonance imaging and CT scans, may help reduce normal tissue damage in patients undergoing radiation therapy for cancer.

PURPOSE: This clinical trial is studying how well radiation therapy planning techniques work in reducing damage to normal tissue in women undergoing breast-conserving surgery for ductal breast carcinoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • To improve precision of tumor bed localization and definition of clinical target volume, and to reduce normal tissue irradiation in women undergoing partial breast or breast boost radiotherapy.
  • To test whether post-operative MRI improves the precision of tumor bed delineation after wide-local excision in comparison with the current standard CT scan/clip method.
  • To determine the impact of tumor position within the excision specimen upon the localization of clinical target volume in relation to the tumor bed.
  • To compare theoretical non-target tissue exposure from partial breast irradiation planned in the supine and prone (face-down) positions.

OUTLINE: Patients undergo planned breast-conservation surgery and placement of titanium clips to the four radial, the deep, and superficial margins of the excision cavity (for localization of tumor bed).

Within 2 weeks after surgery, patients undergo supine radiotherapy-planning CT scan as standard analysis. Patients then undergo a radiotherapy-planning CT scan in the prone position. Patients complete a linear analogue questionnaire after both scans designed to assess patient comfort and anxiety in each position. Patients then undergo multifunctional MRI (including dynamic contrast-enhancement MRI and diffusion-weighted MRI) of the ipsilateral breast in the prone position (≥ 3 weeks after surgery). If suspicious lesions ≥ 5 mm are found on MRI, patients are referred for a second-look ultrasound with biopsy (if lesion visible on ultrasound); where suspicious lesions are seen only on MRI, patients undergo MRI-guided biopsy. Lesions < 5 mm are included in the whole-breast radiotherapy treatment.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

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 Kingdom
    • England
      • Sutton, England, United Kingdom, SM2 5PT
        • Royal Marsden - Surrey

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

DISEASE CHARACTERISTICS:

  • Planning to undergo breast-conserving surgery (BCS)* for unifocal ductal carcinoma in situ (DCIS) or grade 1-2 invasive ductal carcinoma (IDC) of the breast NOTE: *Patients who have underwent BCS and have titanium clips placed according to this protocol are eligible for this study.
  • No T4d or multifocal disease (as defined on mammography or ultrasound)
  • No G3 disease
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • Female
  • Menopausal status not specified

Exclusion criteria:

  • Cup size DD or greater
  • Ferromagnetic implants (exclude participation in MRI)
  • Claustrophobia (exclude participation in MRI)
  • Gadolinium allergy

PRIOR CONCURRENT THERAPY:

  • No prior surgery to ipsilateral breast
  • No prior neoadjuvant 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: Diagnostic
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Difference in lung NTDmean (biologically weighted [normalized] mean of total dose to lung normalized to 2 Gy fractions) in supine vs prone positions

Secondary Outcome Measures

Outcome Measure
Closeness of agreement between MRI-based vs CT scan/clip- based delineation of tumor bed
Closeness of agreement between clinical target volumes (CTVs) defined using uniform margin vs those defined using knowledge of all excision margins
Difference in NTDmean to ipsilateral non-planning target volume (PTV) breast tissue, chest wall muscle, and heart
Difference in mean volume of PTV in supine versus prone positions
Difference in dose homogeneity within PTV in each position
Difference in complexity of beams needed to achieve above dose homogeneity within PTV
Patient comfort with each positioning technique (assessed by questionnaire)

Collaborators and Investigators

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

Sponsor

Royal Marsden NHS Foundation Trust

Investigators

  • Study Chair: John R. Yarnold, MD, FRCR, Royal Marsden NHS Foundation Trust

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

November 1, 2007

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

January 24, 2008

First Submitted That Met QC Criteria

January 24, 2008

First Posted (Estimate)

January 28, 2008

Study Record Updates

Last Update Posted (Estimate)

June 26, 2013

Last Update Submitted That Met QC Criteria

June 25, 2013

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMH-CCR2981
  • CDR0000581130 (Registry Identifier: PDQ (Physician Data Query))

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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