Radiation Therapy Planning Techniques in Reducing Damage to Normal Tissue in Women Undergoing Breast-Conserving Surgery for Ductal Carcinoma of the Breast
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.
Other: questionnaire administration
Procedure: adjuvant therapy
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 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 ]
|Study Start Date:||November 2007|
|Study Completion Date:||January 2009|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00602628
|Royal Marsden - Surrey|
|Sutton, England, United Kingdom, SM2 5PT|
|Study Chair:||John R. Yarnold, MD, FRCR||Royal Marsden NHS Foundation Trust|