Radiation Therapy Planning Techniques in Reducing Damage to Normal Tissue in Women Undergoing Breast-Conserving Surgery for Ductal Carcinoma of the Breast
| Tracking Information | |||||
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| First Received Date ICMJE | January 24, 2008 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | November 2007 | ||||
| Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00602628 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Radiation Therapy Planning Techniques in Reducing Damage to Normal Tissue in Women Undergoing Breast-Conserving Surgery for Ductal Carcinoma of the Breast | ||||
| Official Title ICMJE | 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? | ||||
| 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. |
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| Detailed Description | OBJECTIVES:
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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Breast Cancer | ||||
| Intervention ICMJE |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Inclusion criteria:
Exclusion criteria:
PRIOR CONCURRENT THERAPY:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00602628 | ||||
| Other Study ID Numbers ICMJE | CDR0000581130, RMH-CCR2981 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Royal Marsden NHS Foundation Trust | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | January 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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