Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT01266642 |
| Other study ID # |
2010-0559 |
| Secondary ID |
NCI-2011-0025320 |
| Status |
Active, not recruiting |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
February 8, 2011 |
| Est. completion date |
November 30, 2025 |
Study information
| Verified date |
April 2024 |
| Source |
M.D. Anderson Cancer Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This randomized phase II trial studies how well hypofractionated radiation therapy (RT) works
compared to standard RT in treating patients with ductal breast carcinoma in situ (DCIS) or
early invasive breast cancer. Radiation therapy (RT) uses high energy x-rays to kill tumor
cells. Giving higher doses of RT over a shorter period of time may kill more tumor cells and
have fewer side effects. It is not yet known if hypofractionated RT is more effective than
standard RT in treating breast cancer.
Description:
PRIMARY OBJECTIVES:
I. To compare patient-reported cosmetic outcome at 3 years using the Breast Cancer Treatment
Outcomes Scale (BCTOS) for patients assigned to hypofractionated whole breast irradiation
(HF-WBI) versus conventionally fractionated whole breast irradiation (CF-WBI).
SECONDARY OBJECTIVES:
I. To determine patient-reported cosmetic outcome using the BCTOS at 6 months, 1, 2, 4, and 5
years.
II. To determine physician-rated cosmetic outcome at 6 months, 1, 2, 3, 4, and 5 years using
the Radiation Therapy and Oncology Group (RTOG) scale for physician assessment.
III. To determine the level of agreement between patient-rated cosmetic outcome and
physician-rated cosmetic outcome at the various time points assessed.
IV. To determine the 5-year and risk of pathologically-confirmed invasive and/or in situ
ipsilateral breast tumor recurrence (IBTR) for patients with ductal carcinoma in situ (DCIS)
and early invasive breast cancer.
V. To determine patient-reported functional status and breast pain using the BCTOS at 6
months, 1, 2, 3, 4, and 5 years after treatment.
VI. To determine maximal acute (within 6 weeks of treatment) and late (more than 6 weeks
after treatment) skin and soft tissue toxicities using the National Cancer Institute (NCI)
Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 scale.
VII. To determine the relationship between the volume of breast tissue receiving excessive
dose (defined as greater than 105% of the prescription dose) and the risk of adverse
cosmesis.
VIII. To determine the relationship between bra cup size and the risk of adverse cosmesis.
IX. To determine whether there is a statistical interaction between breast volume and volume
of tissue receiving greater than 105% of the prescription dose in predicting adverse
cosmesis.
X. To determine in an exploratory analysis whether any other demographic, clinical, and
pathologic factors correlate with risk of adverse cosmesis, quality of life, body image,
image investment, and risk of IBTR.
XI. To determine if the C-509T variant allele of transforming growth factor-beta (TGF-beta)
is associated with an increased risk of grade 2 or higher fibrosis (as determined by the
Subjective, Objective, Medical Management, Analytic [SOMA] scale) three years after
completion of radiation.
XII. To compare the cost of radiation for patients treated on the two treatment arms.
XIII. To compare patient quality of life, body image, and appearance investment for the two
treatment arms using the Functional Assessment of Cancer Therapy-Breast (FACT-B), Appearance
Schemas Inventory-Revised (ASI-R), and Body Image Scale, respectively.
XIV. To contribute additional blood samples to protocol LAB02-086 which is a case-control
study investigating deoxyribonucleic acid (DNA) repair phenotypes and genotypes in breast
cancer.
XV. To assess the psychometric profile of the Functional Assessment of Cancer Therapy-Breast
(FACT-B) version 4 in collaboration with investigators from the Department of Medical Social
Science, Northwestern University Feinberg School of Medicine.
XVI. To determine the influence of oncoplastic lumpectomy on the following outcomes:
physician- and patient-reported cosmetic outcomes, other patient-reported health-related
quality of life outcomes, and photographic measurements of breast cosmetic outcome.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo HF-WBI comprising external beam RT 5 days a week for approximately 3
weeks.
ARM II: Patients undergo CF-WBI comprising external beam RT 5 days a week for approximately 5
weeks.
After completion of study treatment, patients are followed up at 6 months and then annually
for 5 years.
