Conformal Partial Breast Irradiation With CyberKnife After Resection for Early Stage Breast Cancer

NCT01290835 | Completed

• 1 other identifier: SMDC10101
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Breast Cancer

Keywords

Stereotactic radiotherapy; CyberKnife following lumpectomy; Breast cancer

Outcome Measures

Primary Outcomes (1)

• To determine the feasibility of using CyberKnife radiotherapy to deliver partial breast radiotherapy for early stage breast cancer.

  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 treated while also respecting normal tissue tolerances.

  one year

Secondary Outcomes (1)

• To determine if conformal irradiation to the operative bed using CyberKnife produces acceptable local control

  1 year

Study Arms (1)

Stereotactic radiotherapy

EXPERIMENTAL

Accelerated stereotactic radiotherapy as an adjuvant treatment for early stage breast cancer.

Radiation: Stereotactic radiotherapy delivered by CyberKnife; Radiation: stereotactic radiotherapy

Interventions

Stereotactic radiotherapy delivered by CyberKnife RADIATION

Adjuvant radiotherapy will be delivered using CyberKnife radiotherapy using twice daily sessions for five days for a total of ten sessions.

Also known as: CyberKnife

Stereotactic radiotherapy

stereotactic radiotherapy RADIATION

Stereotactic radiotherapy

Eligibility Criteria

• Age: 60 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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%

You may not qualify if:

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

Sponsors & Collaborators

• Essentia Health: lead

Study Sites (1)

Essentia Health SMDC Cancer Center

Duluth, Minnesota, 55805, United States

Location

Related Publications (20)

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  PMID: 12192016 BACKGROUND

• 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. doi: 10.1056/NEJMoa022152.

  PMID: 12393820 BACKGROUND

• Clarke M, Collins R, Darby S, Davies C, Elphinstone P, Evans V, 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. doi: 10.1016/S0140-6736(05)67887-7.

  PMID: 16360786 BACKGROUND

• 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. doi: 10.1002/1097-0142(19850901)56:53.0.co;2-n.

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• 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. doi: 10.1093/jnci/88.22.1659.

  PMID: 8931610 BACKGROUND

• 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. doi: 10.1054/bjoc.2000.1571.

  PMID: 11161371 BACKGROUND

• Liljegren G, Holmberg L, Bergh J, Lindgren A, Tabar 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. doi: 10.1200/JCO.1999.17.8.2326.

  PMID: 10561294 BACKGROUND

• 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. doi: 10.1200/JCO.2005.06.032.

  PMID: 16192590 BACKGROUND

• 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. doi: 10.1016/j.amjsurg.2004.06.027.

  PMID: 15474426 BACKGROUND

• 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. doi: 10.1002/cncr.21681.

  PMID: 16421922 BACKGROUND

• 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. doi: 10.1016/j.amjsurg.2007.06.010.

  PMID: 17826055 BACKGROUND

• 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. 2010 Jul 15;77(4):1120-7. doi: 10.1016/j.ijrobp.2009.06.067. Epub 2009 Nov 10.

  PMID: 19910132 BACKGROUND

• 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. doi: 10.1016/j.ijrobp.2009.01.009. Epub 2009 Apr 22.

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• Dornfeld K, Gessert CE, Renier CM, McNaney DD, Urias RE, Knowles DM, Beauduy JL, Widell SL, McDonald BL. Differences in breast tissue oxygenation following radiotherapy. Radiother Oncol. 2011 Aug;100(2):289-92. doi: 10.1016/j.radonc.2011.02.004. Epub 2011 Feb 26.

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• 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. doi: 10.1016/j.ijrobp.2009.02.031.

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• Lovey K, Fodor J, Major T, Szabo E, Orosz Z, Sulyok Z, Janvary L, Frohlich G, Kasler M, Polgar 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. doi: 10.1016/j.ijrobp.2007.03.055. Epub 2007 May 24.

  PMID: 17524571 BACKGROUND

• NCCN Clinical Practice Guidelines in Oncology, V.I.2010,

  BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ken Dornfeld, MD

  Essentia Health Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Study Record Dates

• First Submitted: February 4, 2011
• First Posted: February 7, 2011
• Study Start: June 1, 2010
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

US (1)