Trials / Active Not Recruiting

Active Not RecruitingNCT01266642

Hypofractionated Radiation Therapy or Standard Radiation Therapy in Treating Patients With Ductal Breast Carcinoma In Situ or Early Invasive Breast Cancer

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

Status: Active Not Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 301 (actual)

Sponsor: M.D. Anderson Cancer Center · Academic / Other
Sex: Female
Age: 40 Years
Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

Interventions

Type	Name	Description
RADIATION	External Beam Radiation Therapy	Undergo HF-WBI
RADIATION	External Beam Radiation Therapy	Undergo CF-WBI
RADIATION	Hypofractionated Radiation Therapy	Undergo HF-WBI
OTHER	Laboratory Biomarker Analysis	Optional correlative studies
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
RADIATION	Whole Breast Irradiation	Undergo HF-WBI
RADIATION	Whole Breast Irradiation	Undergo CF-WBI

Timeline

Start date: 2011-02-08
Primary completion: 2020-11-30
Completion: 2040-11-30
First posted: 2010-12-24
Last updated: 2026-03-11
Results posted: 2021-11-19

Locations

7 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT01266642. Inclusion in this directory is not an endorsement.