Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-01-24 @ 7:20 AM
Study NCT ID:
NCT01290835
Status:
COMPLETED
Last Update Posted:
2025-08-15
First Post:
2011-02-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conformal Partial Breast Irradiation With CyberKnife After Resection for Early Stage Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016634', 'term': 'Radiosurgery'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013238', 'term': 'Stereotaxic Techniques'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2011-02-04', 'studyFirstSubmitQcDate': '2011-02-04', 'lastUpdatePostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the feasibility of using CyberKnife radiotherapy to deliver partial breast radiotherapy for early stage breast cancer.', 'timeFrame': 'one year', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'To determine if conformal irradiation to the operative bed using CyberKnife produces acceptable local control', 'timeFrame': '1 year', 'description': 'Subjects will be followed for disease control following standard guidelines that include periodic PE and imaging with either mammography or screening breast MRaI for 5 years.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stereotactic radiotherapy', 'CyberKnife following lumpectomy', 'Breast cancer'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '12192016', 'type': 'BACKGROUND', 'citation': '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. doi: 10.1056/NEJMoa020128.'}, {'pmid': '12393820', 'type': 'BACKGROUND', 'citation': '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': '16360786', 'type': 'BACKGROUND', 'citation': "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': '2990668', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11521809', 'type': 'BACKGROUND', 'citation': '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. doi: 10.1023/a:1011136326943.'}, {'pmid': '8931610', 'type': 'BACKGROUND', 'citation': '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': '11161371', 'type': 'BACKGROUND', 'citation': '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': '10561294', 'type': 'BACKGROUND', 'citation': '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': '16192590', 'type': 'BACKGROUND', 'citation': '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': '15474426', 'type': 'BACKGROUND', 'citation': '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': '16421922', 'type': 'BACKGROUND', 'citation': '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': '17826055', 'type': 'BACKGROUND', 'citation': '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': '19910132', 'type': 'BACKGROUND', 'citation': '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': '19395195', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '21356563', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19545784', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '17409963', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '2916935', 'type': 'BACKGROUND', 'citation': '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. doi: 10.1001/archsurg.1989.01410020023002.'}, {'pmid': '17524571', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': 'NCCN Clinical Practice Guidelines in Oncology, V.I.2010,'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of breast malignancy, stage T1\n2. Surgical treatment with lumpectomy\n3. age 60 or older\n4. resection margins negative by at least 2mm\n5. any grade\n6. ER positive\n7. unicentric\n8. invasive ductal\n9. pathologic free of nodal metastases (N0, i- or i+)\n10. Post-lumpectomy cavity to whole breast ratio must be less than or equal to 30%\n\nExclusion criteria\n\n1. Prior radiotherapy to the breast\n2. Neoadjuvant chemotherapy\n3. multicentric disease\n4. Pure DCIS histology\n5. Presence of extensive intraductal component\n6. Node positive disease (N1 or greater)'}, 'identificationModule': {'nctId': 'NCT01290835', 'acronym': 'CKPBI', 'briefTitle': 'Conformal Partial Breast Irradiation With CyberKnife After Resection for Early Stage Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Essentia Health'}, 'officialTitle': 'Conformal Partial Breast Irradiation With CyberKnife After Resection for Early Stage Breast Cancer', 'orgStudyIdInfo': {'id': 'SMDC10101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stereotactic radiotherapy', 'description': 'Accelerated stereotactic radiotherapy as an adjuvant treatment for early stage breast cancer.', 'interventionNames': ['Radiation: Stereotactic radiotherapy delivered by CyberKnife', 'Radiation: stereotactic radiotherapy']}], 'interventions': [{'name': 'Stereotactic radiotherapy delivered by CyberKnife', 'type': 'RADIATION', 'otherNames': ['CyberKnife'], 'description': 'Adjuvant radiotherapy will be delivered using CyberKnife radiotherapy using twice daily sessions for five days for a total of ten sessions.', 'armGroupLabels': ['Stereotactic radiotherapy']}, {'name': 'stereotactic radiotherapy', 'type': 'RADIATION', 'armGroupLabels': ['Stereotactic radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55805', 'city': 'Duluth', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Essentia Health SMDC Cancer Center', 'geoPoint': {'lat': 46.78327, 'lon': -92.10658}}], 'overallOfficials': [{'name': 'Ken Dornfeld, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Essentia Health Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Essentia Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Radiation Oncologist', 'investigatorFullName': 'Ken Dornfeld', 'investigatorAffiliation': 'Essentia Health'}}}}