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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
This study has been completed.
Sponsored by: Royal Marsden - Surrey
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00602628
  Purpose

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.


Condition Intervention
Breast Cancer
Procedure: adjuvant therapy
Procedure: biopsy
Procedure: computed tomography
Procedure: dynamic contrast-enhanced magnetic resonance imaging
Procedure: magnetic resonance imaging
Procedure: questionnaire administration
Procedure: radiation therapy
Procedure: therapeutic conventional surgery
Procedure: ultrasound imaging

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer CT Scans Cancer MRI Scans
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Open Label
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?

Further study details as provided by National Cancer Institute (NCI):

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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Closeness of agreement between MRI-based vs CT scan/clip- based delineation of tumor bed [ Designated as safety issue: No ]
  • Closeness of agreement between clinical target volumes (CTVs) defined using uniform margin vs those defined using knowledge of all excision margins [ Designated as safety issue: No ]
  • Difference in NTDmean to ipsilateral non-planning target volume (PTV) breast tissue, chest wall muscle, and heart [ Designated as safety issue: No ]
  • Difference in mean volume of PTV in supine versus prone positions [ Designated as safety issue: No ]
  • Difference in dose homogeneity within PTV in each position [ Designated as safety issue: No ]
  • Difference in complexity of beams needed to achieve above dose homogeneity within PTV [ Designated as safety issue: No ]
  • Patient comfort with each positioning technique (assessed by questionnaire) [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2007
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00602628

Locations
United Kingdom, England
Royal Marsden - Surrey
Sutton, England, United Kingdom, SM2 5PT
Sponsors and Collaborators
Royal Marsden - Surrey
Investigators
Study Chair: John R. Yarnold, MD, FRCR Royal Marsden - Surrey
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000581130, RMH-CCR2981
Study First Received: January 24, 2008
Last Updated: January 9, 2009
ClinicalTrials.gov Identifier: NCT00602628  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Carcinoma, Ductal
Skin Diseases
Carcinoma in Situ
Breast Neoplasms
Carcinoma, Ductal, Breast
Carcinoma, Intraductal, Noninfiltrating
Adenocarcinoma
Breast Diseases
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on January 14, 2009