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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
questionnaire administration
adjuvant therapy
biopsy
computed tomography
dynamic contrast-enhanced magnetic resonance imaging
magnetic resonance imaging
therapeutic conventional surgery
ultrasound imaging
radiation therapy
Sponsored by
Royal Marsden NHS Foundation Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring ductal breast carcinoma in situ, invasive ductal breast carcinoma, breast cancer in situ, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Marsden - Surrey

Outcomes

Primary Outcome Measures

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

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)

Full Information

First Posted
January 24, 2008
Last Updated
June 25, 2013
Sponsor
Royal Marsden NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00602628
Brief Title
Radiation Therapy Planning Techniques in Reducing Damage to Normal Tissue in Women Undergoing Breast-Conserving Surgery for Ductal Carcinoma of the Breast
Official Title
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?
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Royal Marsden NHS Foundation Trust

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
ductal breast carcinoma in situ, invasive ductal breast carcinoma, breast cancer in situ, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Masking
None (Open Label)
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
biopsy
Intervention Type
Procedure
Intervention Name(s)
computed tomography
Intervention Type
Procedure
Intervention Name(s)
dynamic contrast-enhanced magnetic resonance imaging
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance imaging
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Intervention Type
Procedure
Intervention Name(s)
ultrasound imaging
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Closeness of agreement between MRI-based vs CT scan/clip- based delineation of tumor bed
Title
Closeness of agreement between clinical target volumes (CTVs) defined using uniform margin vs those defined using knowledge of all excision margins
Title
Difference in NTDmean to ipsilateral non-planning target volume (PTV) breast tissue, chest wall muscle, and heart
Title
Difference in mean volume of PTV in supine versus prone positions
Title
Difference in dose homogeneity within PTV in each position
Title
Difference in complexity of beams needed to achieve above dose homogeneity within PTV
Title
Patient comfort with each positioning technique (assessed by questionnaire)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John R. Yarnold, MD, FRCR
Organizational Affiliation
Royal Marsden NHS Foundation Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Royal Marsden - Surrey
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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