Conformal Partial Breast Irradiation With CyberKnife After Resection for Early Stage Breast Cancer - Full Text View

Purpose

The purpose of this study is to determine if it is feasible, safe, and effective to use Cyberknife radiotherapy to deliver partial breast radiotherapy after lumpectomy.Patients meeting eligibility criteria will be invited to participate. Adjuvant radiotherapy will be delivered using CyberKnife radiotherapy using twice daily sessions for five days for a total of ten sessions. Short-term and long-term toxicity will be assessed as well as Tumor control and site of failure (if any).

Condition	Intervention	Phase
Breast Cancer	Radiation: Stereotactic radiotherapy delivered by CyberKnife	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Conformal Partial Breast Irradiation With CyberKnife After Resection for Early Stage Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by Essentia Health:

Primary Outcome Measures:

To determine the feasibility of using CyberKnife radiotherapy to deliver partial breast radiotherapy for early stage breast cancer. [ Time Frame: one year ] [ Designated as safety issue: No ]
Subjects will undergo a treatment plan for partial breast irradiation with cyberknife. Feasibility will be determined by monitoring the number of potential eligible subjects enrolled that can be treatedwhile also respecting normal tissue tolerances.

Secondary Outcome Measures:

To determine if conformal irradiation to the operative bed using CyberKnife produces acceptable local control [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Subjects will be followed for disease control following standard guidelines that include periodic PE and imaging with either mammograpy or screening breast MRaI for 5 years.

Enrollment:	20
Study Start Date:	June 2010
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Stereotactic radiotherapy for breast cancer Accelerated radiotherapy as an adjuvant treatment for early stage breast cancer.	Radiation: Stereotactic radiotherapy delivered by CyberKnife Adjuvant radiotherapy will be delivered using CyberKnife radiotherapy using twice daily sessions for five days for a total of ten sessions. Other Name: CyberKnife

Detailed Description:

This study will determine the feasibility and toxicity of a short course of accelerated radiotherapy as adjuvant treatment for early stage breast cancer. Successful completion of this project may provide a rationale to offer this treatment for select patients with the benefit of potentially less tissue damage and a shorter overall course of therapy. These improvements may ultimately allow more patients the opportunity of breast conserving therapy to treat their cancer

Eligibility

Ages Eligible for Study:	60 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of breast malignancy, stage T1
Surgical treatment with lumpectomy
age 60 or older
resection margins negative by at least 2mm
any grade
ER positive
unicentric
invasive ductal
pathologic free of nodal metastases (N0, i- or i+)
Post-lumpectomy cavity to whole breast ratio must be less than or equal to 30%

Exclusion criteria

Prior radiotherapy to the breast
Neoadjuvant chemotherapy
multicentric disease
Pure DCIS histology
Presence of extensive intraductal component
Node positive disease (N1 or greater)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01290835

Locations

United States, Minnesota
Essentia Health SMDC Cancer Center
Duluth, Minnesota, United States, 55805

Sponsors and Collaborators

Essentia Health

Investigators

Principal Investigator:

Ken Dornfeld, MD

Essentia Health Oncology

More Information

Publications:

Fisher B, Jeong JH, Anderson S, Bryant J, Fisher ER, Wolmark N. Twenty-five-year follow-up of a randomized trial comparing radical mastectomy, total mastectomy, and total mastectomy followed by irradiation. N Engl J Med. 2002 Aug 22;347(8):567-75.

Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41.

Clarke M, Collins R, Darby S, Davies C, Elphinstone P, Evans E, Godwin J, Gray R, Hicks C, James S, MacKinnon E, McGale P, McHugh T, Peto R, Taylor C, Wang Y; Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 Dec 17;366(9503):2087-106. Review.

Holland R, Veling SH, Mravunac M, Hendriks JH. Histologic multifocality of Tis, T1-2 breast carcinomas. Implications for clinical trials of breast-conserving surgery. Cancer. 1985 Sep 1;56(5):979-90.

Veronesi U, Marubini E, Mariani L, Galimberti V, Luini A, Veronesi P, Salvadori B, Zucali R. Radiotherapy after breast-conserving surgery in small breast carcinoma: long-term results of a randomized trial. Ann Oncol. 2001 Jul;12(7):997-1003.

Clark RM, Whelan T, Levine M, Roberts R, Willan A, McCulloch P, Lipa M, Wilkinson RH, Mahoney LJ. Randomized clinical trial of breast irradiation following lumpectomy and axillary dissection for node-negative breast cancer: an update. Ontario Clinical Oncology Group. J Natl Cancer Inst. 1996 Nov 20;88(22):1659-64.

Holli K, Saaristo R, Isola J, Joensuu H, Hakama M. Lumpectomy with or without postoperative radiotherapy for breast cancer with favourable prognostic features: results of a randomized study. Br J Cancer. 2001 Jan;84(2):164-9.

Liljegren G, Holmberg L, Bergh J, Lindgren A, Tabár L, Nordgren H, Adami HO. 10-Year results after sector resection with or without postoperative radiotherapy for stage I breast cancer: a randomized trial. J Clin Oncol. 1999 Aug;17(8):2326-33.

Schroen AT, Brenin DR, Kelly MD, Knaus WA, Slingluff CL Jr. Impact of patient distance to radiation therapy on mastectomy use in early-stage breast cancer patients. J Clin Oncol. 2005 Oct 1;23(28):7074-80.

Benitez PR, Chen PY, Vicini FA, Wallace M, Kestin L, Edmundson G, Gustafson G, Martinez A. Partial breast irradiation in breast conserving therapy by way of intersitial brachytherapy. Am J Surg. 2004 Oct;188(4):355-64.

Chen PY, Vicini FA, Benitez P, Kestin LL, Wallace M, Mitchell C, Pettinga J, Martinez AA. Long-term cosmetic results and toxicity after accelerated partial-breast irradiation: a method of radiation delivery by interstitial brachytherapy for the treatment of early-stage breast carcinoma. Cancer. 2006 Mar 1;106(5):991-9.

Benitez PR, Keisch ME, Vicini F, Stolier A, Scroggins T, Walker A, White J, Hedberg P, Hebert M, Arthur D, Zannis V, Quiet C, Streeter O, Silverstein M. Five-year results: the initial clinical trial of MammoSite balloon brachytherapy for partial breast irradiation in early-stage breast cancer. Am J Surg. 2007 Oct;194(4):456-62.

Vicini F, Winter K, Wong J, Pass H, Rabinovitch R, Chafe S, Arthur D, Petersen I, White J, McCormick B. Initial Efficacy Results of RTOG 0319: Three-Dimensional Conformal Radiation Therapy (3D-CRT) Confined to the Region of the Lumpectomy Cavity for Stage I/ II Breast Carcinoma. Int J Radiat Oncol Biol Phys. 2009 Nov 10; [Epub ahead of print]

Hepel JT, Tokita M, MacAusland SG, Evans SB, Hiatt JR, Price LL, DiPetrillo T, Wazer DE. Toxicity of three-dimensional conformal radiotherapy for accelerated partial breast irradiation. Int J Radiat Oncol Biol Phys. 2009 Dec 1;75(5):1290-6.

Smith BD, Arthur DW, Buchholz TA, Haffty BG, Hahn CA, Hardenbergh PH, Julian TB, Marks LB, Todor DA, Vicini FA, Whelan TJ, White J, Wo JY, Harris JR. Accelerated partial breast irradiation consensus statement from the American Society for Radiation Oncology (ASTRO). Int J Radiat Oncol Biol Phys. 2009 Jul 15;74(4):987-1001.

Le QT, Loo BW, Ho A, Cotrutz C, Koong AC, Wakelee H, Kee ST, Constantinescu D, Whyte RI, Donington J. Results of a phase I dose-escalation study using single-fraction stereotactic radiotherapy for lung tumors. J Thorac Oncol. 2006 Oct;1(8):802-9.

Rose MA, Olivotto I, Cady B, Koufman C, Osteen R, Silver B, Recht A, Harris JR. Conservative surgery and radiation therapy for early breast cancer. Long-term cosmetic results. Arch Surg. 1989 Feb;124(2):153-7.

Lövey K, Fodor J, Major T, Szabó E, Orosz Z, Sulyok Z, Jánváry L, Fröhlich G, Kásler M, Polgár C. Fat necrosis after partial-breast irradiation with brachytherapy or electron irradiation versus standard whole-breast radiotherapy--4-year results of a randomized trial. Int J Radiat Oncol Biol Phys. 2007 Nov 1;69(3):724-31. Epub 2007 May 24.

Responsible Party:	Ken Dornfeld MD, Essentia Health SMDC Cancer Center
ClinicalTrials.gov Identifier:	NCT01290835 History of Changes
Other Study ID Numbers:	SMDC10101
Study First Received:	February 4, 2011
Last Updated:	February 4, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Essentia Health:

Stereotactic radiotherapy
CyberKnife following lumpectomy
Breast cancer

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013

Conformal Partial Breast Irradiation With CyberKnife After Resection for Early Stage Breast Cancer (CK PBI)