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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by James Graham Brown Cancer Center
Sponsor:
Collaborator:
University of Louisville
Information provided by (Responsible Party):
James Graham Brown Cancer Center
ClinicalTrials.gov Identifier:
NCT01278212
First received: January 12, 2011
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Breast Cancer
Radiation: accelerated hypofractionated radiotherapy (AHF-RT)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by James Graham Brown Cancer Center:

Primary Outcome Measures:
  • ipsilateral breast tumor recurrence (IBTR), as determined by mammogram [ Time Frame: at 5 years post completion of AHF-RT ] [ Designated as safety issue: No ]
    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 [ Time Frame: at 5 years post completion of AHF-RT ] [ Designated as safety issue: No ]
    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 [ Time Frame: at 5 years post completion of AHF-RT ] [ Designated as safety issue: No ]
    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 [ Time Frame: at 5 years post completion of AHF-RT ] [ Designated as safety issue: No ]
  • treatment toxicities [ Time Frame: at 6 months post completion of AHF-RT ] [ Designated as safety issue: Yes ]
  • breast cosmesis, measured by a patient self-report instrument, physician cosmetic evaluation, and digital photographs of the treated and untreated breasts [ Time Frame: at 18 months post completion of AHF-RT ] [ Designated as safety issue: No ]
    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) [ Time Frame: at 18 months post completion of AHF-RT ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: January 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: accelerated hypofractionated radiation

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

  1. must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines
  2. must be at least 21 years old
  3. must have stage 0, I, or II breast cancer
  4. On histological examination, the tumor must be ductal carcinoma in situ (DCIS) or invasive adenocarcinoma of the breast.
  5. 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.
  6. Gross disease may be unifocal or multifocal with pathologic (invasive and/or DCIS) tumor size excised with negative margins.
  7. 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.
  8. 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)
  9. 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).
  10. At the time of study enrollment, patients must have had a history & physical exam within 4 months and a bilateral mammogram within 6 months.
  11. 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.
  12. 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.

  1. T3, stage III, or stage IV breast cancer
  2. More than 3 histologically positive axillary nodes
  3. Axillary nodes with definite evidence of microscopic or macroscopic extracapsular extension
  4. One or more positive non-axillary sentinel node(s) (Note that intramammary nodes are staged as axillary nodes.)
  5. 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
  6. Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign
  7. Non-epithelial breast malignancies such as sarcoma or lymphoma
  8. Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by 4 or more centimeters
  9. Paget's disease of the nipple
  10. Synchronous bilateral invasive or non-invasive breast cancer
  11. History of invasive breast cancer or DCIS (Patients with a history of lobular carcinoma in situ (LCIS) treated by surgery alone are eligible.)
  12. 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.)
  13. Treatment plan that includes regional nodal irradiation
  14. 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.)
  15. Cosmetic breast implants (Patients who have had implants removed are eligible.)
  16. Prior breast or thoracic RT for any condition
  17. Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma
  18. 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.
  19. Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01278212

Contacts
Contact: Clinical Trials Office, Brown Cancer Center 502-562-3429 ctobcc@louisville.edu

Locations
United States, Kentucky
James Graham Brown Cancer Center Recruiting
Louisville, Kentucky, United States, 40202
Principal Investigator: Anthony E. Dragun, MD         
Sponsors and Collaborators
James Graham Brown Cancer Center
University of Louisville
Investigators
Principal Investigator: Anthony E. Dragun, MD James Graham Brown Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: James Graham Brown Cancer Center
ClinicalTrials.gov Identifier: NCT01278212     History of Changes
Other Study ID Numbers: 10.0584, BCC-AHF-RT-10
Study First Received: January 12, 2011
Last Updated: March 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by James Graham Brown Cancer Center:
breast cancer
breast neoplasm
breast tumor
radiotherapy
radiation
accelerated
lumpectomy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014