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

Breast Cancer Clinical Trial

— 2009-APBI  

Official title:

A Phase III Randomized Study Comparing Intensity Modulated Planning Versus 3-Dimensional Planning for Accelerated Partial Breast Radiotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01185132
• Other study ID #: 2009-APBI
• Secondary ID: WIRB #20091193
• Status: Recruiting
• Phase: Phase 3
• First received: August 18, 2010
• Last updated: June 24, 2014
• Start date: July 2009
• Est. completion date: July 2028

Study information

• Verified date: June 2014
• Source: Rocky Mountain Cancer Centers
• Contact: Rachel Lei, BS
• Phone: 303-418-7607
• Email: rachel.lei[@]usoncology.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 660
• Est. completion date: July 2028
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• accelerated partial breast irradiation - 3D-conformal planning
38.5 Gy, 10 fractions over 5 days
• accelerated partial breast irradiation - IMRT planning
38.5 Gy, 10 fractions over 5 days

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Rocky Mountain Cancer Centers

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of breast pain after Accelerated Partial Breast Radiotherapy (APBI)	Assessment by both treating investigators and by subjective patient outcomes questionnaires filled out at each follow-up visit	5 years	Yes
Primary	Prevalence of chest wall pain after Accelerated Partial Breast Radiotherapy (APBI)	Assessment by both treating investigators and by subjective patient outcomes questionnaires filled out at each follow-up visit	2-5 years	Yes
Secondary	Dosimetric comparison	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	5-10 days	Yes
Secondary	Acute skin reactions	Radiation-induced dermatitis	6 months	Yes
Secondary	Cosmetic outcomes after APBI	Assesed by both treating investigators and subjective patient questionnaires filled out at each follow-up visit	2-5 years	No
Secondary	Ipsilateral breast event	Track occurrence and patterns of local treatment failures or new primaries within the treated breast (efficacy outcome measure)	5-15 years	No
Secondary	Cause specific survival	Track survival status and the specific cause(s) of death if applicable for study participants (efficacy outcome measure)	5-15 years	No
Secondary	Disease free survival	Track breast-cancer free survival status of study participants (efficacy outcome measure)	5-15 years	No
Secondary	Overall survival	Track the overall survival status of all study participants (efficacy outcome measure)	5-15 years	No