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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Rocky Mountain Cancer Centers
Study ID
NCT01185132
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 31, 2009
Status verified
Jun 2014
Primary completion
Jul 31, 2018
Completion
Jul 31, 2028

Study Design

Enrollment
660 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IMRT
    Intensity modulated radiotherapy, 38.5 Gy, 10 fractions over 5 days
  • Active Comparator: 3D-CRT
    Three dimensional conformal external radiotherapy, 38.5 Gy, 10 fractions over 5 days

Primary Outcome Measure

Prevalence of breast pain after Accelerated Partial Breast Radiotherapy (APBI) [ Time Frame: 5 years ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Rocky Mountain Cancer Centers - AuroraAuroraColorado80012
Dennis Carter, MD (SUB_INVESTIGATOR)
William Daniel, MD (SUB_INVESTIGATOR)
Kathryn Howell, MD (SUB_INVESTIGATOR)
Rocky Mountain Cancer Centers - BoulderBoulderColorado80303
Andrew Antell, MD (SUB_INVESTIGATOR)
Meera Patel, MD (SUB_INVESTIGATOR)
Ralph Wright, MD (SUB_INVESTIGATOR)
Rocky Mountain Cancer Centers - LakewoodLakewoodColorado80228
Ralph Wright, MD (SUB_INVESTIGATOR)
Charles Leonard, MD (PRINCIPAL_INVESTIGATOR)
Rocky Mountain Cancer Centers - LittletonLittletonColorado80120
Charles Leonard, MD (PRINCIPAL_INVESTIGATOR)
Kathryn Howell, MD (SUB_INVESTIGATOR)
Rocky Mountain Cancer Centers - ThorntonThorntonColorado80260
Robert LaPorte, MD (SUB_INVESTIGATOR)
Daniel Chin, MD (SUB_INVESTIGATOR)

Find similar trials in Aurora, CO

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Rocky Mountain Cancer Centers - Aurora· Aurora, CORocky Mountain Cancer Centers - Boulder· Boulder, CORocky Mountain Cancer Centers - Lakewood· Lakewood, CORocky Mountain Cancer Centers - Littleton· Littleton, CORocky Mountain Cancer Centers - Thornton· Thornton, CO

Related Studies