Know Cancer

or
forgot password

Randomized Trial of Hypofractionated Whole Breast Irradiation Versus Conventionally Fractionated Whole Breast Irradiation for Ductal Carcinoma in Situ and Early Invasive Breast Cancer


Phase 2
40 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

Randomized Trial of Hypofractionated Whole Breast Irradiation Versus Conventionally Fractionated Whole Breast Irradiation for Ductal Carcinoma in Situ and Early Invasive Breast Cancer


Study Questionnaire and Photographs:

If you agree to take part in this study, you will complete questionnaires about your general
health and how your breast currently looks and feels. This should take about 15 minutes to
complete. Photographs will also be taken of your breast and your doctor will rate the way
your breast looks before you begin receiving radiation. You will not be able to be
identified in the photographs. The photographs will be kept as part of your medical record.
You will also have a physical exam and your medical history will be recorded.

Study Groups:

You will then be randomly assigned (as in the flip of a coin) to 1 of 2 groups. Group 1
will receive shorter radiation. Group 2 will receive standard radiation.

For shorter radiation (Group 1), you will receive about 3 weeks of radiation (16 treatments)
to the entire breast. You will also have 4-5 additional treatments of radiation as a
"boost". The boost will be delivered to the part of the breast where the disease first
started.

For standard radiation (Group 2), you will receive about 5 weeks of radiation (25
treatments) to the entire breast. You will also have 5-7 additional treatments of radiation
as a boost to the part of the breast where the disease started.

Study Visits:

While you are receiving radiation, you will be asked about any side effects you may be
having each week.

Follow-up Visit:

You will return to the clinic for follow-up visits 6 months and 1, 2, 3, 4, and 5 years
after you have finished receiving radiation. At each follow-up visit, you will fill out the
study questionnaire, more photographs will be taken of your breast, and you will be asked
about any side effects you may be having. You will also have a physical exam and your
medical history will be recorded.

Length of Study:

After the 5-year follow-up visit, you will be off study.

This is an investigational study. Both the standard and the shorter radiation courses are
FDA-approved in patients with breast cancer. The goal of this study is to compare the 2
treatments.

Up to 288 participants will be enrolled in this study. All will be enrolled at MD Anderson.


Inclusion Criteria:



1. Pathologically confirmed ductal carcinoma in situ of the breast or early invasive
breast cancer defined as pathologic stage Tis, T1, or T2, N0, N1mic, or N1a
(pathologic staging of the axilla is required for all patients with invasive disease
but is not required for patients with DCIS only).

2. Treatment with breast conserving surgery.

3. Final surgical margins must be negative, defined as no evidence for ductal carcinoma
in situ or invasive breast cancer touching the inked surgical margin. If the invasive
or in situ breast cancer approaches within less than 1 mm of the final surgical
margin, then a reexcision is strongly encouraged. Lobular carcinoma in situ at the
final surgical margin will be disregarded.

4. Age 40 years or older. This age cutoff is justified because breast cancers in women
under the age of 40 are known to have a significantly higher risk of IBTR presumably
due to underlying biologic differences.

5. Female sex.

6. Attending radiation oncologist declares intention to treat the whole breast only and
that a third radiation field to treat regional lymph nodes is not planned (radiation
of the undissected level I/II axilla with high tangents is allowed).

7. If the patient has a history of a prior non-breast cancer, all treatment for this
cancer must have been completed prior to study registration and the patient must have
no evidence of disease for this prior non-breast cancer.

8. Patients must be enrolled on the trial within 12 weeks of the later of two dates: the
final breast conserving surgical procedure or administration of the last cycle of
cytotoxic chemotherapy.

Exclusion Criteria:

1. Pathologic or clinical evidence for a stage T3 or T4 breast cancer.

2. Pathologic evidence for involvement of 4 or more axillary lymph nodes, or imaging
evidence of involvement of infraclavicular, supraclavicular, or internal mammary
lymph nodes.

3. Clinical or pathologic evidence for distant metastases.

4. Any prior diagnosis of invasive or ductal carcinoma in situ breast cancer in either
breast.

5. Current diagnosis of bilateral breast cancer.

6. History of therapeutic irradiation to the breast, lower neck, mediastinum or other
area in which there could potentially be overlap with the affected breast.

7. Patients not fluent in English or Spanish. (The Informed Consent will be available in
these two languages)

8. Patient is pregnant.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Percent Women with Adverse Cosmetic Scores at 3 Years

Outcome Description:

Comparison of patient-reported cosmetic outcomes using Breast Cancer Treatment Outcomes Scale (BCTOS): 1) Hypofractionated whole breast irradiation (HF-WBI) versus 2) Conventionally fractionated whole breast irradiation (CF-WBI). Number of women with adverse cosmetic scores at 3 years after completion of breast conserving surgery, as determined by the patient-reported BCTOS where a score of 2.5 or more indicates an adverse cosmetic outcome.

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Benjamin Smith, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2010-0559

NCT ID:

NCT01266642

Start Date:

February 2011

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • Early invasive breast cancer
  • Ductal carcinoma in situ of the breast
  • Tis
  • T1
  • T2
  • N0
  • N1mic
  • N1a
  • Lumpectomy
  • Hypofractionated whole breast irradiation
  • HF-WBI
  • Conventionally fractionated whole breast irradiation
  • CF-WBI
  • Radiation therapy
  • Radiotherapy
  • Breast Neoplasms
  • Carcinoma in Situ
  • Carcinoma, Intraductal, Noninfiltrating
  • Carcinoma, Ductal, Breast
  • Carcinoma, Ductal

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030