Accelerated Hypofractionated Radiotherapy (AHF-RT) for the Treatment of Breast Cancer

Sponsor

University of Louisville (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01278212

Collaborator

James Graham Brown Cancer Center (Other)

155

Enrollment

Location

Arm

179

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this study is to explore the safety, effectiveness, quality of life, and cost effectiveness of accelerated hypofractionated radiotherapy (AHF-RT) as treatment after lumpectomy in patients with early stage breast cancer.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Radiation: accelerated hypofractionated radiotherapy (AHF-RT)	N/A

Detailed Description

The traditional radiation treatment schedule for patients who have had a lumpectomy for early stage breast cancer is 15 to 30 treatments delivered once a day for 3 to 6 weeks. This treatment schedule can be inconvenient and costly for elderly, rural, uninsured, and minority patients. This study will evaluate a new radiation treatment schedule called whole-breast accelerated hypofractionated radiotherapy (AHF-RT). AHF-RT delivers higher doses of radiation in fewer treatments than traditional radiation therapy. The AHF-RT treatment course is completed with 5 radiation treatments delivered once a week for 5 weeks.

The purpose of this study is to determine if accelerated hypofractionated radiotherapy (AHF-RT) is a safe, effective, more convenient, and less costly alternative to traditional radiation that will offer the same chance of cure with no additional side effects.

Study Design

Study Type:

Interventional

Actual Enrollment :

155 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Study of Accelerated Hypofractionated Radiotherapy (AHF-RT) After Breast Conserving Surgery (BCS) in Medically Underserved Patients

Study Start Date :

Jan 1, 2011

Anticipated Primary Completion Date :

Oct 1, 2021

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AHF-RT accelerated hypofractionated radiotherapy (AHF-RT) 30 Gy in 5 fractions once a week for 5 weeks, followed by optional boost of 10-16 Gy	Radiation: accelerated hypofractionated radiotherapy (AHF-RT) 30 Gy in 5 fractions once a week for 5 weeks, followed by optional boost of 10-16 Gy Other Names: accelerated hypofractionated radiation

Arm

Intervention/Treatment

Experimental: AHF-RT

accelerated hypofractionated radiotherapy (AHF-RT) 30 Gy in 5 fractions once a week for 5 weeks, followed by optional boost of 10-16 Gy

Radiation: accelerated hypofractionated radiotherapy (AHF-RT)

30 Gy in 5 fractions once a week for 5 weeks, followed by optional boost of 10-16 Gy

Other Names:

accelerated hypofractionated radiation

Outcome Measures

Primary Outcome Measures

ipsilateral breast tumor recurrence (IBTR), as determined by mammogram [at 5 years post completion of AHF-RT]
Both invasive and non-invasive IBTRs will be considered in calculating the primary endpoint.

Secondary Outcome Measures

Distant disease-free interval, as determined by mammogram [at 5 years post completion of AHF-RT]
Distant disease-free interval is defined as the time from enrollment to first diagnosis of distant disease, regardless of the occurrence of any intervening local or regional failure, contralateral breast cancer, or non-breast second primaries.
Recurrence-free survival, as determined by mammogram [at 5 years post completion of AHF-RT]
Recurrence-free survival is defined as the time from enrollment to first diagnosis of a local, regional, or distant recurrence, regardless of any intervening contralateral or other second primary cancer.
overall survival [at 5 years post completion of AHF-RT]
treatment toxicities [at 6 months post completion of AHF-RT]
breast cosmesis, measured by a patient self-report instrument, physician cosmetic evaluation, and digital photographs of the treated and untreated breasts [at 18 months post completion of AHF-RT]
Two digital images will be taken at each assessment point (a close up of the treated breast alone in order to provide detailed information regarding the treatment effects and a straight frontal view of both breasts taken in either a standing or seated position with the patient's hands symmetrically placed on her hips, taking care to exclude her face and framing or focusing on both the treated and untreated breast to allow optimal comparison of the breasts for symmetry.
Quality of Life, as measured by a patient-completed breast cancer specific QOL instrument (EORTC QLQ-BR23) [at 18 months post completion of AHF-RT]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Only women who satisfy all of the following conditions will be eligible for this study.

must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines
must be at least 21 years old
must have stage 0, I, or II breast cancer
On histological examination, the tumor must be ductal carcinoma in situ (DCIS) or invasive adenocarcinoma of the breast.
Surgical treatment of the breast must have been breast conserving surgery (BCS). The margins of the resected specimen must be histologically free of tumor (including DCIS component). Reexcision of surgical margins is permitted.
Gross disease may be unifocal or multifocal with pathologic (invasive and/or DCIS) tumor size excised with negative margins.
Patients with invasive breast cancer are required to have axillary staging which can include sentinel node biopsy alone (if sentinel node is negative), sentinel node biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary nodes (if sentinel node is positive), or axillary dissection alone (with a minimum of 6 axillary nodes). Axillary staging is not required for patients with DCIS.
must begin adjuvant therapy (chemotherapy or radiotherapy) within 9 weeks following the last surgery for breast cancer (lumpectomy, re-excision of margins, or axillary staging procedure)
Patients must have all usual and customary hormone receptor (ER/PR) and estrogen receptor (ER) analysis performed on the primary tumor prior to enrollment. Patients with invasive disease must have HER2 receptor status determined (positive or negative) with immuno-histochemistry (IHC) and/or fluorescent in-situ hybridization (FISH).
At the time of study enrollment, patients must have had a history & physical exam within 4 months and a bilateral mammogram within 6 months.
Patients with a history of non-breast malignancies are eligible if they have been disease-free for 5 or more years prior to enrollment and are deemed by their physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
Patients must live in a county that is designated as Appalachian and/or rural by Kentucky Cancer Registry Criteria (see list below) and/or must hold their primary residence at least 10 miles from the nearest radiation facility. Patients who do not fit these criteria may still be considered eligible if they are determined to suffer significant financial and/or transportation hardship during a typical course of CF-RT or HF-RT (in the judgment of any of their treating physicians). Patients who live outside the Commonwealth of Kentucky are eligible if they fit any of these aforementioned conditions.

Appalachian counties in KY include: Adair, Bath, Bell, Boyd, Breathitt, Carter, Casey, Clark, Clay, Clinton, Cumberland, Edmonson, Elliott, Estill, Fleming, Floyd, Garrard, Green, Greenup, Harlan, Hart, Jackson, Johnson, Knott, Knox, Laurel, Lawrence, Lee, Leslie, Letcher, Lewis, Lincoln, Madison, Magoffin, Martin, McCreary, Menifee, Metcalfe, Monroe, Montgomery, Morgan, Nicholas, Owsley, Perry, Pike, Powell, Pulaski, Robertson, Rockcastle, Rowan, Russell, Wayne, Whitley, Wolfe.

Exclusion Criteria:

Men are not eligible for this study. Women with one or more of the following conditions are ineligible for this study.

T3, stage III, or stage IV breast cancer
More than 3 histologically positive axillary nodes
Axillary nodes with definite evidence of microscopic or macroscopic extracapsular extension
One or more positive non-axillary sentinel node(s) (Note that intramammary nodes are staged as axillary nodes.)
Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor
Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign
Non-epithelial breast malignancies such as sarcoma or lymphoma
Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by 4 or more centimeters
Paget's disease of the nipple
Synchronous bilateral invasive or non-invasive breast cancer
History of invasive breast cancer or DCIS (Patients with a history of lobular carcinoma in situ (LCIS) treated by surgery alone are eligible.)
Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation (If surgical margins are rendered free of disease by reexcision, the patient is eligible.)
Treatment plan that includes regional nodal irradiation
Current therapy with any hormonal agents such as raloxifene (Evista®), tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or breast cancer prevention (Patients are eligible only if these medications are discontinued prior to enrollment.)
Cosmetic breast implants (Patients who have had implants removed are eligible.)
Prior breast or thoracic RT for any condition
Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma
Pregnancy or lactation at the time of proposed randomization. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy.
Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements