Clinical trial NCT00602628: Radiation Therapy Planning Techniques in Reducing Damage to Normal Tissue in Women Undergoing Breast-Conserving Surgery for Ductal Carcinoma of the Breast
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2008-01-28
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: DIAGNOSTIC

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.

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 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

Primary outcomes:
measure: Difference in lung NTDmean (biologically weighted [normalized] mean of total dose to lung normalized to 2 Gy fractions) in supine vs prone positions
Secondary outcomes:
measure: Closeness of agreement between MRI-based vs CT scan/clip- based delineation of tumor bed
measure: Closeness of agreement between clinical target volumes (CTVs) defined using uniform margin vs those defined using knowledge of all excision margins
measure: Difference in NTDmean to ipsilateral non-planning target volume (PTV) breast tissue, chest wall muscle, and heart
measure: Difference in mean volume of PTV in supine versus prone positions
measure: Difference in dose homogeneity within PTV in each position
measure: Difference in complexity of beams needed to achieve above dose homogeneity within PTV
measure: Patient comfort with each positioning technique (assessed by questionnaire)
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Royal Marsden - Surrey
state: England
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: John R. Yarnold, MD, FRCR
role: STUDY_CHAIR
References: