Intensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy (2009-APBI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Rocky Mountain Cancer Centers
Sponsor:
Information provided by (Responsible Party):
Rocky Mountain Cancer Centers
ClinicalTrials.gov Identifier:
NCT01185132
First received: August 18, 2010
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Radiation: accelerated partial breast irradiation - 3D-conformal planning
Radiation: accelerated partial breast irradiation - IMRT planning
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Randomized Study Comparing Intensity Modulated Planning Versus 3-Dimensional Planning for Accelerated Partial Breast Radiotherapy

Resource links provided by NLM:


Further study details as provided by Rocky Mountain Cancer Centers:

Primary Outcome Measures:
  • Prevalence of breast pain after Accelerated Partial Breast Radiotherapy (APBI) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: 2-5 years ] [ Designated as safety issue: Yes ]
    Assessment by both treating investigators and by subjective patient outcomes questionnaires filled out at each follow-up visit


Secondary Outcome Measures:
  • Dosimetric comparison [ Time Frame: 5-10 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Radiation-induced dermatitis

  • Cosmetic outcomes after APBI [ Time Frame: 2-5 years ] [ Designated as safety issue: No ]
    Assesed by both treating investigators and subjective patient questionnaires filled out at each follow-up visit

  • Ipsilateral breast event [ Time Frame: 5-15 years ] [ Designated as safety issue: No ]
    Track occurrence and patterns of local treatment failures or new primaries within the treated breast (efficacy outcome measure)

  • Cause specific survival [ Time Frame: 5-15 years ] [ Designated as safety issue: No ]
    Track survival status and the specific cause(s) of death if applicable for study participants (efficacy outcome measure)

  • Disease free survival [ Time Frame: 5-15 years ] [ Designated as safety issue: No ]
    Track breast-cancer free survival status of study participants (efficacy outcome measure)

  • Overall survival [ Time Frame: 5-15 years ] [ Designated as safety issue: No ]
    Track the overall survival status of all study participants (efficacy outcome measure)


Estimated Enrollment: 660
Study Start Date: July 2009
Estimated Study Completion Date: July 2028
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IMRT
Intensity modulated radiotherapy, 38.5 Gy, 10 fractions over 5 days
Radiation: accelerated partial breast irradiation - IMRT planning
38.5 Gy, 10 fractions over 5 days
Other Names:
  • APBI
  • EBRT
Active Comparator: 3D-CRT
Three dimensional conformal external radiotherapy, 38.5 Gy, 10 fractions over 5 days
Radiation: accelerated partial breast irradiation - 3D-conformal planning
38.5 Gy, 10 fractions over 5 days
Other Names:
  • APBI
  • EBRT

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01185132

Contacts
Contact: Rachel Lei, BS 303-418-7607 rachel.lei@usoncology.com
Contact: Charles Leonard, MD 303-730-4700

Locations
United States, Colorado
Rocky Mountain Cancer Centers - Aurora Recruiting
Aurora, Colorado, United States, 80012
Sub-Investigator: Dennis Carter, MD         
Sub-Investigator: William Daniel, MD         
Sub-Investigator: Kathryn Howell, MD         
Rocky Mountain Cancer Centers - Boulder Recruiting
Boulder, Colorado, United States, 80303
Sub-Investigator: Andrew Antell, MD         
Sub-Investigator: Meera Patel, MD         
Sub-Investigator: Ralph Wright, MD         
Rocky Mountain Cancer Centers - Lakewood Recruiting
Lakewood, Colorado, United States, 80228
Sub-Investigator: Ralph Wright, MD         
Principal Investigator: Charles Leonard, MD         
Rocky Mountain Cancer Centers - Littleton Recruiting
Littleton, Colorado, United States, 80120
Principal Investigator: Charles Leonard, MD         
Sub-Investigator: Kathryn Howell, MD         
Rocky Mountain Cancer Centers - Thornton Recruiting
Thornton, Colorado, United States, 80260
Sub-Investigator: Robert LaPorte, MD         
Sub-Investigator: Daniel Chin, MD         
Sponsors and Collaborators
Rocky Mountain Cancer Centers
Investigators
Principal Investigator: Charles Leonard, MD Rocky Mountain Cancer Centers
  More Information

No publications provided

Responsible Party: Rocky Mountain Cancer Centers
ClinicalTrials.gov Identifier: NCT01185132     History of Changes
Other Study ID Numbers: 2009-APBI, WIRB #20091193
Study First Received: August 18, 2010
Last Updated: June 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Rocky Mountain Cancer Centers:
breast-conservation
adjuvant radiotherapy
breast cancer
early-stage breast cancer
DCIS
lumpectomy
accelerated partial breast irradiation
APBI
three dimensional conformal external radiotherapy
intensity modulated radiotherapy
3D CRT
IMRT

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 24, 2014