Radiation Therapy Planning Techniques in Reducing Damage to Normal Tissue in Women Undergoing Breast-Conserving Surgery for Ductal Carcinoma of the Breast

NCT ID: NCT00602628

Last Updated: 2013-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2009-01-31

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.

Conditions

Breast Cancer

Study Design

• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

questionnaire administration

Intervention Type: OTHER

adjuvant therapy

Intervention Type: PROCEDURE

biopsy

Intervention Type: PROCEDURE

computed tomography

Intervention Type: PROCEDURE

dynamic contrast-enhanced magnetic resonance imaging

Intervention Type: PROCEDURE

magnetic resonance imaging

Intervention Type: PROCEDURE

therapeutic conventional surgery

Intervention Type: PROCEDURE

ultrasound imaging

Intervention Type: PROCEDURE

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• No T4d or multifocal disease (as defined on mammography or ultrasound)
• No G3 disease
• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role: lead

Principal Investigators

John R. Yarnold, MD, FRCR

Role: STUDY_CHAIR

Royal Marsden NHS Foundation Trust

Locations

Royal Marsden - Surrey

Sutton, England, United Kingdom

Countries

United Kingdom

Other Identifiers

CDR0000581130

Identifier Type: REGISTRY

Identifier Source: secondary_id

RMH-CCR2981

Identifier Type: -

Identifier Source: org_study_id