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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|ClinicalTrials.gov Identifier: NCT00602628|
Recruitment Status : Completed
First Posted : January 28, 2008
Last Update Posted : June 26, 2013
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 or disease||Intervention/treatment||Phase|
|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||Not Applicable|
- 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 (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Masking:||None (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?|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||January 2009|
- Difference in lung NTDmean (biologically weighted [normalized] mean of total dose to lung normalized to 2 Gy fractions) in supine vs prone positions
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00602628
|Royal Marsden - Surrey|
|Sutton, England, United Kingdom, SM2 5PT|
|Study Chair:||John R. Yarnold, MD, FRCR||Royal Marsden NHS Foundation Trust|