Intensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy

Phase 3

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT01185132
• Lead Sponsor: Rocky Mountain Cancer Centers

Brief Summary

In the setting of radiotherapy as part of breast-conservation therapy for patients with early stage breast cancer, the novel planning and delivery method of intensity modulated radiotherapy is an effective and safe alternative to the commonly-used standard 3D-conformal external beam radiotherapy, spares more normal breast and lung tissue, and may lead to improved clinical outcomes.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2010-08-18
• Study First Submitted QC: 2010-08-18
• Study First Posted: 2010-08-19
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-24
• Last Update Posted: 2014-06-26
• Primary Completion: 2018-07
• Study Completion: 2028-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 660

Inclusion Criteria

• Histologically confirmed disease (AJC Classification): Tis, T1, T2 (≤ 3.0 cm), N0, M0.
• Microscopic multifocal disease is only allowed when the entire span of identified disease measures 3.0 cm or less.
• Negative surgical margins ( ≥ 0.2 cm) after final surgery.
• Subjects with infiltrating lobular histologies or high nuclear grade DCIS will be required to have breast MRI scanning as part of the initial staging to verify localized disease.
• Subjects with DCIS will be included in the study only if they had an MRI prior to lumpectomy.
• Findings on MRI scanning revealing relevant suspicion of disease outside of planned lumpectomy volume should be further evaluated by ultrasound and, if necessary biopsy, to exclude multicentric/multifocal disease.
• Subjects with malignant calcifications on mammography will be required to have repeat mammography after surgery to ensure removal of all malignant calcifications.
• Willing to complete additional screening requirements and meet eligibility criteria as defined in protocol Sec. 4.4.
• Successful placement of fiducial markers for IGRT requiring nonmigrating fiducials.
• PTV to ipsilateral breast ratio (IBR) ≤ 25 %.
• Radiotherapy anticipated to begin within 10 weeks of lumpectomy or re-excision of margins.

Exclusion Criteria

• Pregnancy or breast-feeding.
• Have collagen-vascular disease.
• Inadequate surgical margins ( < 0.2 cm) after final surgery.
• Subjects with persistent malignant/suspicious micro-calcifications.
• Gross multifocal disease and microscopic disease greater than 3.0 cm.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Prevalence of breast pain after Accelerated Partial Breast Radiotherapy (APBI)	5 years	Assessment by both treating investigators and by subjective patient outcomes questionnaires filled out at each follow-up visit
Prevalence of chest wall pain after Accelerated Partial Breast Radiotherapy (APBI)	2-5 years	Assessment by both treating investigators and by subjective patient outcomes questionnaires filled out at each follow-up visit

Secondary Outcome Measures

Name	Time	Method
Dosimetric comparison	5-10 days	Comparison of treatment plans and actual doses received between comparable patients treated with 3D-CRT and IMRT with regard to treatment target and normal tissue
Acute skin reactions	6 months	Radiation-induced dermatitis
Ipsilateral breast event	5-15 years	Track occurrence and patterns of local treatment failures or new primaries within the treated breast (efficacy outcome measure)
Cause specific survival	5-15 years	Track survival status and the specific cause(s) of death if applicable for study participants (efficacy outcome measure)
Cosmetic outcomes after APBI	2-5 years	Assesed by both treating investigators and subjective patient questionnaires filled out at each follow-up visit
Disease free survival	5-15 years	Track breast-cancer free survival status of study participants (efficacy outcome measure)
Overall survival	5-15 years	Track the overall survival status of all study participants (efficacy outcome measure)

Trial Locations

Locations (5)

Rocky Mountain Cancer Centers - Aurora; 🇺🇸 Aurora, Colorado, United States

Rocky Mountain Cancer Centers - Boulder; 🇺🇸 Boulder, Colorado, United States

Rocky Mountain Cancer Centers - Lakewood; 🇺🇸 Lakewood, Colorado, United States

Rocky Mountain Cancer Centers - Littleton; 🇺🇸 Littleton, Colorado, United States

Rocky Mountain Cancer Centers - Thornton; 🇺🇸 Thornton, Colorado, United States