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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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 |
Other: questionnaire administration Procedure: adjuvant therapy Procedure: biopsy Procedure: computed tomography Procedure: dynamic contrast-enhanced magnetic resonance imaging Procedure: magnetic resonance imaging Procedure: therapeutic conventional surgery Procedure: ultrasound imaging Radiation: radiation therapy |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Diagnostic |
| 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? |
- 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 ]
- 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) |
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 |
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| United Kingdom | |
| Royal Marsden - Surrey | |
| Sutton, England, United Kingdom, SM2 5PT | |
| Study Chair: | John R. Yarnold, MD, FRCR | Royal Marsden NHS Foundation Trust |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00602628 History of Changes |
| Other Study ID Numbers: | CDR0000581130, RMH-CCR2981 |
| Study First Received: | January 24, 2008 |
| Last Updated: | February 6, 2009 |
| 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 |
Additional relevant MeSH terms:
|
Breast Neoplasms Carcinoma, Ductal, Breast Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Carcinoma, Ductal Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Ductal, Lobular, and Medullary |
ClinicalTrials.gov processed this record on May 16, 2013